Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, relapse/ refractory multiple myeloma, bispecific antibody, bispecific, BCMA, BCMA- CD3 bispecific, Phase 1, PF-06863135, dexamethasone, lenalidomide, pomalidomide
Brief summary
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed description
Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.
Interventions
DRUGPF-06863135 + dexamethasone
PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
DRUGPF-06863135 + lenalidomide
PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
DRUGPF-06863135 + pomalidomide
PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
DRUGPF-06863135 monotherapy IV or SC
PF-06863135 will be administered intravenously or subcutaneously.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Relapsed/refractory multiple myeloma * Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody * Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma) * Adequate bone marrow, hematological, kidney and liver function * Resolved acute effects of any prior therapy to baseline severity * Not pregnant
Exclusion criteria
* Recent history of other malignancies * History of active autoimmune disorders * Any form of primary immunodeficiency * Active and clinically significant bacterial, fungal, or viral infection * Evidence of active mucosal or internal bleeding * History of severe immune-mediated adverse event with prior immunomodulatory treatment * Major surgery within 4 weeks of study treatment start * Radiation therapy within 2 weeks of study treatment start * History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment * Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry * Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy * Requirement for systemic immune suppressive medication except as permitted in the protocol * Current requirement for chronic blood product support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | Cycle 1 (21 Days) | Hematological: Grade 4 neutropenia lasting \>5 days; Febrile neutropenia \<1000/mm\^3 with a single temperature of \>38.3 degree Celsius (C) or a sustained temperature of \>=38 degree C for more than one hour; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with \>= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting \>=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to \<=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor. |
| Part 2: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria | From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months) | ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by \>=90% or to \<200 mg/24 hr. If serum and urine M-protein were unmeasurable, \>=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria. |
| Part 2: Duration of Response (DOR) as Per IMWG Criteria | From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 34.3 months) | DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas&\<5% plasma cells in bone marrow aspirates.VGPR: serum & urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp & reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum & urine Mp were unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months) | Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported. |
| Part 1: ORR as Per IMWG Criteria | From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months) | ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by \>=90% or to \<200 mg/24 hr. If serum and urine M-protein were unmeasurable, \>=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria. |
| Part 1: Time to Response (TTR) as Per IMWG Criteria | From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months) | TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum& urine & disappearance of soft tissue plasmacytomas & \<5% plasma cells in bone marrow aspirates. VGPR: serum& urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein& reduction in 24hrs urinary M-protein by \>=90% or \<200 mg/24hr. If serum & urine M-protein unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. |
| Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months) | CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. |
| Part 1: Concentration of Soluble Cytokines in Serum | Part 1: C1 (0, 2, 4 & 8 hours [h] post dose on Day [D] 1, 24h post dose on D2, 72h post dose on D3); Part 1.1, 1C & 1D: C0 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2); C1 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2, 72h post dose on D3) | The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure. Cycle = C. |
| Part 1: DOR as Per IMWG Criteria | From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 63.31 months) | DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas&\<5% plasma cells in bone marrow aspirates.VGPR: serum & urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp & reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum & urine Mp were unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types. |
| Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 63.31 months) | DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. |
| Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 63.31 months) | DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum & urine &disappearance of any soft tissue plasmacytomas &\<5% plasma cells in bone marrow aspirates. VGPR: serum & urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp & reduction in 24 hours urinary Mp by \>=90% or\<200 mg/24 hr. If serum & urine Mp were unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. |
| Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 63.31 months) | PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. |
| Part 1: Overall Survival (OS) | Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 63.31 months) | OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive. |
| Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first (maximum up to 63.31 months) | MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10\^-5 and 10\^-6. |
| Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2 | Cmax of PF-06863135 was measured in this outcome measure. Total is free and bound drug in the body. |
| Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2 | Area under the concentration curve from time 0 to end of dosing interval (AUCtau) was measured in this outcome measure. Total is free and bound drug in the body. |
| Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 1 (0 hours post dose on Day 1, 8 and 15); Cycle 2 (0 hours on Day 15) | Plasma concentration of lenalidomide and pomalidomide was measured in this outcome measure. |
| Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months) | AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs. |
| Part 2: Concentration of Soluble Cytokines in Serum | Cycle 0 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2); Cycle 1 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2, 72 hours post dose on Day 3) | The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure. |
| Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months) | AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs. |
| Part 2: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months) | Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported. |
| Part 2: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months) | Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported. |
| Part 2: Number of Participants With Shifts From Grade <=2 to Grade 3 or 4 Post-Baseline in Urinalysis | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months) | Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported. |
| Part 2: CRR as Per IMWG Criteria | From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months) | CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. |
| Part 2: DoCR as Per IMWG Criteria | From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 34.3 months) | DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. |
| Part 2: Number of Participants With ADA and NAb Against PF-06863135 | From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 34.3 months) | Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted). |
| Part 2: TTR as Per IMWG Criteria | From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months) | TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum& urine & disappearance of soft tissue plasmacytomas & \<5% plasma cells in bone marrow aspirates. VGPR: serum& urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein& reduction in 24hrs urinary M-protein by \>=90% or \<200 mg/24hr. If serum & urine M-protein unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. |
| Part 2: DOSD as Per IMWG Criteria | Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 34.3 months) | DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum & urine &disappearance of any soft tissue plasmacytomas &\<5% plasma cells in bone marrow aspirates. VGPR: serum & urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp & reduction in 24 hours urinary Mp by \>=90% or\<200 mg/24 hr. If serum & urine Mp were unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. |
| Part 2: PFS as Per IMWG Criteria | From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 34.3 months) | PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. |
| Part 2: OS | Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 34.3 months) | OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive. |
| Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria | Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy whichever occurred first (maximum up to 34.3 months) | MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10\^-5 and 10\^-6. |
| Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 63.31 months) | Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted). |
| Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months) | Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported. |
| Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months) | Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported. |
Countries
Canada, United States
Participant flow
Recruitment details
A total of 101 participants (Part 1: 86 participants and Part 2: 15 participants) were enrolled in the study.
Pre-assignment details
The following parts were planned for the study: Part 1 dose escalation included Part 1 monotherapy, Part 1.1 dose priming, Part 1C lenalidomide combination, Part 1D pomalidomide combination and Part 1E dexamethasone combination. Part 2 dose expansion included Part 2A monotherapy, Part 2C lenalidomide combination, Part 2D pomalidomide combination and Part 2E dexamethasone combination. Participants were not enrolled in Parts 1E, 2C, 2D and 2E and their data is not reported in the record.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 2 |
| Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 3 |
| Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 2 |
| Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 3 |
| Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 2 |
| Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 5 |
| Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 6 |
| Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 6 |
| Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 4 |
| Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 4 |
| Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 4 |
| Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 7 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 13 |
| Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 9 |
| Part 2A: PF-06863135 SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first. | 15 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1: Dose Escalation | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 0 | 0 | 1 | 0 |
| Part 1: Dose Escalation | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 |
| Part 1: Dose Escalation | Disease Relapse | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: Dose Escalation | Global Deterioration of Health Status | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: Dose Escalation | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1: Dose Escalation | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 3 | 1 | 1 | 0 |
| Part 1: Dose Escalation | Progressive Disease | 2 | 3 | 2 | 3 | 2 | 5 | 3 | 5 | 3 | 1 | 2 | 2 | 3 | 3 | 8 | 3 | 4 | 0 |
| Part 1: Dose Escalation | Refused Further Treatment | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part 1: Dose Escalation | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 0 | 1 | 0 |
| Part 2A: Dose Expansion | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Part 2A: Dose Expansion | Disease Relapse | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part 2A: Dose Expansion | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part 2A: Dose Expansion | Progressive Disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 9 |
| Part 2A: Dose Expansion | Refused Further Treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: PF-06863135 1 mcg/kg IV | Part 1: PF-06863135 3 mcg/kg IV | Part 1: PF-06863135 10 mcg/kg IV | Part 1: PF-06863135 30 mcg/kg IV | Part 1: PF-06863135 50 mcg/kg IV | Part 1: PF-06863135 80 mcg/kg SC | Part 1: PF-06863135 130 mcg/kg SC | Part 1: PF-06863135 215 mcg/kg SC | Part 1: PF-06863135 360 mcg/kg SC | Part 1: PF-06863135 600 mcg/kg SC | Part 1: PF-06863135 1000 mcg/kg SC | Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1C: PF-06863135 + Lenalidomide SC | Part 1D: PF-06863135 + Pomalidomide SC | Part 2A: PF-06863135 SC | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.0 Years STANDARD_DEVIATION 4.24 | 67.3 Years STANDARD_DEVIATION 4.04 | 53.0 Years STANDARD_DEVIATION 0 | 63.3 Years STANDARD_DEVIATION 9.24 | 54.5 Years STANDARD_DEVIATION 4.95 | 70.8 Years STANDARD_DEVIATION 14.15 | 67.0 Years STANDARD_DEVIATION 8.92 | 67.3 Years STANDARD_DEVIATION 8.73 | 63.8 Years STANDARD_DEVIATION 11.64 | 68.5 Years STANDARD_DEVIATION 9.11 | 62.0 Years STANDARD_DEVIATION 3.92 | 59.5 Years STANDARD_DEVIATION 8.31 | 58.5 Years STANDARD_DEVIATION 11.48 | 60.0 Years STANDARD_DEVIATION 12.22 | 67.4 Years STANDARD_DEVIATION 7.26 | 60.5 Years STANDARD_DEVIATION 22.49 | 58.9 Years STANDARD_DEVIATION 8.33 | 66.7 Years STANDARD_DEVIATION 9.65 | 63.7 Years STANDARD_DEVIATION 10.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 5 Participants | 6 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 5 Participants | 7 Participants | 13 Participants | 4 Participants | 8 Participants | 13 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants | 6 Participants | 6 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 4 Participants | 5 Participants | 10 Participants | 2 Participants | 8 Participants | 10 Participants | 71 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants | 6 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 4 Participants | 5 Participants | 4 Participants | 1 Participants | 3 Participants | 7 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 9 Participants | 3 Participants | 6 Participants | 8 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 2 | 2 / 3 | 2 / 2 | 3 / 3 | 2 / 2 | 4 / 5 | 4 / 6 | 5 / 6 | 1 / 4 | 3 / 4 | 3 / 4 | 3 / 6 | 2 / 6 | 3 / 7 | 4 / 13 | 2 / 4 | 4 / 9 | 10 / 15 | 19 / 23 | 17 / 30 | 7 / 20 |
| other Total, other adverse events | 2 / 2 | 3 / 3 | 2 / 2 | 3 / 3 | 2 / 2 | 5 / 5 | 6 / 6 | 6 / 6 | 4 / 4 | 4 / 4 | 4 / 4 | 6 / 6 | 6 / 6 | 7 / 7 | 13 / 13 | 4 / 4 | 9 / 9 | 13 / 15 | 23 / 23 | 30 / 30 | 20 / 20 |
| serious Total, serious adverse events | 0 / 2 | 1 / 3 | 0 / 2 | 3 / 3 | 0 / 2 | 2 / 5 | 5 / 6 | 4 / 6 | 1 / 4 | 3 / 4 | 3 / 4 | 4 / 6 | 5 / 6 | 6 / 7 | 9 / 13 | 2 / 4 | 8 / 9 | 12 / 15 | 11 / 23 | 20 / 30 | 15 / 20 |
Outcome results
Primary
Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03
Hematological: Grade 4 neutropenia lasting \>5 days; Febrile neutropenia \<1000/mm\^3 with a single temperature of \>38.3 degree Celsius (C) or a sustained temperature of \>=38 degree C for more than one hour; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with \>= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting \>=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to \<=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor.
Time frame: Cycle 1 (21 Days)
Population: DLT evaluable set included all participants that had experienced a DLT in the DLT observation period or received all of their planned doses of PF-06863135 in the initial DLT observation period if Q2W dosing was being evaluated or at least all but one of their planned doses of PF-0686135 if Q1W dosing was being evaluated, provided a dose was not missed due to toxicity attributed to study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 1 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 1 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 1 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 1 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 3 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 2 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 0 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03 | 1 Participants |
Primary
Part 2: Duration of Response (DOR) as Per IMWG Criteria
DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas&\<5% plasma cells in bone marrow aspirates.VGPR: serum & urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp & reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum & urine Mp were unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.
Time frame: From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 34.3 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Duration of Response (DOR) as Per IMWG Criteria | 11.6 Months |
Primary
Part 2: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria
ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by \>=90% or to \<200 mg/24 hr. If serum and urine M-protein were unmeasurable, \>=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
Population: Modified intent to treat (mITT) analysis set included all participants who have received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria | 60.0 Percentage of participants |
Secondary
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau)
Area under the concentration curve from time 0 to end of dosing interval (AUCtau) was measured in this outcome measure. Total is free and bound drug in the body.
Time frame: 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
Population: PK parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 0.1654 Microgram*day per milliliter | Geometric Coefficient of Variation 74 |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 0.0009462 Microgram*day per milliliter | Geometric Coefficient of Variation 1.95 |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 2.190 Microgram*day per milliliter | Geometric Coefficient of Variation 11 |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | 0.05280 Microgram*day per milliliter | Geometric Coefficient of Variation 2.59 |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 0.7801 Microgram*day per milliliter | Geometric Coefficient of Variation 24 |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 3.322 Microgram*day per milliliter | Geometric Coefficient of Variation 40 |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 1.206 Microgram*day per milliliter | Geometric Coefficient of Variation 62 |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 0.3344 Microgram*day per milliliter | Geometric Coefficient of Variation 72 |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 1.182 Microgram*day per milliliter | Geometric Coefficient of Variation 58 |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 1.478 Microgram*day per milliliter | Geometric Coefficient of Variation 23 |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | 13.47 Microgram*day per milliliter | Geometric Coefficient of Variation 39 |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | 2.572 Microgram*day per milliliter | Geometric Coefficient of Variation 49 |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 4.426 Microgram*day per milliliter | Geometric Coefficient of Variation 17 |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 4.362 Microgram*day per milliliter | Geometric Coefficient of Variation 103 |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 12.58 Microgram*day per milliliter | Geometric Coefficient of Variation 26 |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | 45.14 Microgram*day per milliliter | Geometric Coefficient of Variation 113 |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 17.92 Microgram*day per milliliter | Geometric Coefficient of Variation 29 |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 4.909 Microgram*day per milliliter | Geometric Coefficient of Variation 42 |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | 76.83 Microgram*day per milliliter | Geometric Coefficient of Variation 30 |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | 34.18 Microgram*day per milliliter | Geometric Coefficient of Variation 155 |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 25.53 Microgram*day per milliliter | Geometric Coefficient of Variation 36 |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | 88.92 Microgram*day per milliliter | Geometric Coefficient of Variation 31 |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 6.564 Microgram*day per milliliter | Geometric Coefficient of Variation 33 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 11.92 Microgram*day per milliliter | Geometric Coefficient of Variation 109 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 0 Day 1 | 4.111 Microgram*day per milliliter | Geometric Coefficient of Variation 49 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | 45.63 Microgram*day per milliliter | Geometric Coefficient of Variation 128 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 58.93 Microgram*day per milliliter | Geometric Coefficient of Variation 14 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 0 Day 1 | 16.82 Microgram*day per milliliter | Geometric Coefficient of Variation 20 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | 173.4 Microgram*day per milliliter | Geometric Coefficient of Variation 21 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 0 Day 1 | 5.054 Microgram*day per milliliter | Geometric Coefficient of Variation 73 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | 66.20 Microgram*day per milliliter | Geometric Coefficient of Variation 63 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 34.13 Microgram*day per milliliter | Geometric Coefficient of Variation 60 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 93.96 Microgram*day per milliliter | Geometric Coefficient of Variation 53 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | 148.1 Microgram*day per milliliter | Geometric Coefficient of Variation 65 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 0 Day 1 | 16.93 Microgram*day per milliliter | Geometric Coefficient of Variation 46 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 0 Day 1 | 2.447 Microgram*day per milliliter | Geometric Coefficient of Variation 92 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 8.896 Microgram*day per milliliter | Geometric Coefficient of Variation 12 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 54.78 Microgram*day per milliliter | Geometric Coefficient of Variation 16 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 0 Day 1 | 9.643 Microgram*day per milliliter | Geometric Coefficient of Variation 148 |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 0 Day 1 | 3.487 Microgram*day per milliliter | Geometric Coefficient of Variation 50 |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 1 Day 1 | 11.40 Microgram*day per milliliter | Geometric Coefficient of Variation 91 |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Free PF-06863135: Cycle 2 Day 1 | NA Microgram*day per milliliter | — |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 0 Day 1 | 10.91 Microgram*day per milliliter | Geometric Coefficient of Variation 37 |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) | Total PF-06863135: Cycle 1 Day 1 | 31.92 Microgram*day per milliliter | Geometric Coefficient of Variation 45 |
Secondary
Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide
Plasma concentration of lenalidomide and pomalidomide was measured in this outcome measure.
Time frame: Cycle 1 (0 hours post dose on Day 1, 8 and 15); Cycle 2 (0 hours on Day 15)
Population: PK Concentration Analysis Set was defined as all participants randomized and treated who had at least 1 measurable PF-06863135 concentration.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 1 Day 15 | 70.60 nanogram/milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 1 Day 1 | NA nanogram/milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 2 Day 15 | 36.70 nanogram/milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 1 Day 8 | 70.70 nanogram/milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 2 Day 15 | 0.0000 nanogram/milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 1 Day 1 | NA nanogram/milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 1 Day 15 | 32.70 nanogram/milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide | Cycle 1 Day 8 | 13.60 nanogram/milliliter |
Secondary
Part 1: Complete Response Rate (CRR) as Per IMWG Criteria
CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates.
Time frame: From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 50.0 Percentage of participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 25.0 Percentage of participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 50.0 Percentage of participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 50.0 Percentage of participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 14.3 Percentage of participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 46.2 Percentage of participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 50.0 Percentage of participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 33.3 Percentage of participants |
| Part 1: PF-06863135 Total IV | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 Total SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 30.0 Percentage of participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Complete Response Rate (CRR) as Per IMWG Criteria | 35.0 Percentage of participants |
Secondary
Part 1: Concentration of Soluble Cytokines in Serum
The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure. Cycle = C.
Time frame: Part 1: C1 (0, 2, 4 & 8 hours [h] post dose on Day [D] 1, 24h post dose on D2, 72h post dose on D3); Part 1.1, 1C & 1D: C0 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2); C1 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2, 72h post dose on D3)
Population: The Pharmacodynamic (PD)/Biomarker analysis set included all enrolled participants with at least 1 of the PD/Biomarkers evaluated at pre- and/or post-dose. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 6.50 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 7.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 6.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 7.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 5.50 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 6.50 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 7.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 8.50 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 6.50 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 8.00 Picogram per milliliter |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 17.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.50 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 40.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 8.50 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 11.0 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 106.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 9.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 53.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 7.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 11.0 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 9.50 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 73.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 10.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 25.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 8.50 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 8.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 83.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 6.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 12.50 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 7.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 10.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 8.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 9.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 6.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 16.50 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 7.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.50 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 46.50 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 6.50 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 8.50 Picogram per milliliter |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 10.50 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.50 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.50 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 12.50 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 6.50 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 29.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 8.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 15.50 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 11.0 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 6.50 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 184.50 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 21.50 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 18.50 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 12.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.00 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 2.00 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 7.20 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 2.00 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 8.95 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 31.25 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 24.85 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 59.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 52.50 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 2 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 129.65 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 24 hours | 201.40 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 8 hours | 88.40 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 89.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 0 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 2 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 4 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 8 hours | 10.30 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 24 hours | 5.00 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 4 hours | 11.50 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 2 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 0 hours | 2.00 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 0 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 2 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 4 hours | 3.30 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 8 hours | 9.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 24 hours | 3.80 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 24 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 8 hours | 14.30 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 4 hours | 2.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 56.45 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 0 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 58.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 0 hours | 2.00 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 2 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 24 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 30.45 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 24 hours | 7.40 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 4 hours | 2.50 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 8 hours | 7.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 35.00 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 4 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 1.80 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 38.35 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 0 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 2 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 8 hours | 7.40 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 22.95 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 4 hours | 3.60 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 24 hours | 3.80 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 24.50 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 0 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 8 hours | 17.90 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 1.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 2.45 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 24 hours | 122.70 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 4.20 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 20.60 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 0 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 2 hours | 2.00 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 2.10 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 8 hours | 129.90 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 4 hours | 10.40 Picogram per milliliter |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 2 hours | 1.70 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 2.90 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 0 hours | 2.00 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 2 hours | 1.70 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 2 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 4 hours | 2.60 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 8 hours | 3.05 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 8.05 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 24 hours | 3.15 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 0 hours | 2.00 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 2 hours | 2.00 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 7.45 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 3.15 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 4 hours | 3.75 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 24 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 8 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 4 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 12.80 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 2.55 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 2 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 3.85 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 0 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 12.25 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 2.80 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 24 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 8 hours | 3.70 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 1.70 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 8 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 4 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 9.30 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 0 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 12.15 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 24 hours | 8.50 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 2.10 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 4.20 Picogram per milliliter |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 1.70 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 4 hours | 5.25 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 2 hours | 2.00 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 8 hours | 2.00 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 2.25 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 1.70 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 0 hours | 2.00 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 24 hours | 2.30 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 4 hours | 2.40 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 2.00 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 8 hours | 1.75 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 0 hours | 1.70 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 2.90 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 2.30 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 1.70 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 4 hours | 1.70 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 2 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 24 hours | 33.60 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 0 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 1.70 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 32.75 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 4 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 8 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 2 hours | 2.35 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 1.70 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 24 hours | 4.20 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 0 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 24 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 2 hours | 2.10 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 2.00 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 1.70 Picogram per milliliter |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 8 hours | 2.10 Picogram per milliliter |
Secondary
Part 1: DOR as Per IMWG Criteria
DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas&\<5% plasma cells in bone marrow aspirates.VGPR: serum & urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp & reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum & urine Mp were unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.
Time frame: From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 63.31 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and for arms where it is 0 signifies there was no participant with confirmed objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: DOR as Per IMWG Criteria | 25.3 Months |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: DOR as Per IMWG Criteria | 13.6 Months |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: DOR as Per IMWG Criteria | NA Months |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: DOR as Per IMWG Criteria | NA Months |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: DOR as Per IMWG Criteria | 6.7 Months |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: DOR as Per IMWG Criteria | 17.1 Months |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: DOR as Per IMWG Criteria | 14.9 Months |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: DOR as Per IMWG Criteria | 8.3 Months |
| Part 1: PF-06863135 Total SC | Part 1: DOR as Per IMWG Criteria | 32.2 Months |
| Part 1.1: PF-06863135 Total SC | Part 1: DOR as Per IMWG Criteria | 13.3 Months |
Secondary
Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria
DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Time frame: From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 63.31 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and for arms where it is 0 signifies there was no participant with complete response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | 25.3 Months |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | NA Months |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | NA Months |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | NA Months |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | NA Months |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | NA Months |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | NA Months |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | NA Months |
| Part 1: PF-06863135 Total SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | 31.5 Months |
| Part 1.1: PF-06863135 Total SC | Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria | 11.5 Months |
Secondary
Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria
DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum & urine &disappearance of any soft tissue plasmacytomas &\<5% plasma cells in bone marrow aspirates. VGPR: serum & urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp & reduction in 24 hours urinary Mp by \>=90% or\<200 mg/24 hr. If serum & urine Mp were unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Time frame: Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 63.31 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and for arm where it is 0 signifies there was no participant with stable disease.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 1.3 Months |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | NA Months |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 0.8 Months |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | NA Months |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 3.4 Months |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 3.0 Months |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 0.4 Months |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 0.6 Months |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 18.4 Months |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 13.6 Months |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 32.2 Months |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | NA Months |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 7.4 Months |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 17.6 Months |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 17.9 Months |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 5.6 Months |
| Part 1: PF-06863135 Total IV | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 1.8 Months |
| Part 1: PF-06863135 Total SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 7.3 Months |
| Part 1.1: PF-06863135 Total SC | Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria | 12.0 Months |
Secondary
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135
Cmax of PF-06863135 was measured in this outcome measure. Total is free and bound drug in the body.
Time frame: 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
Population: Pharmacokinetic (PK) parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.0008828 Micrograms per milliliter | Geometric Coefficient of Variation 1.23 |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 0.05363 Micrograms per milliliter | Geometric Coefficient of Variation 36 |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | NA Micrograms per milliliter | — |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 0.2855 Micrograms per milliliter | Geometric Coefficient of Variation 37 |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.1851 Micrograms per milliliter | Geometric Coefficient of Variation 40 |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 0.6044 Micrograms per milliliter | Geometric Coefficient of Variation 27 |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 0.9924 Micrograms per milliliter | Geometric Coefficient of Variation 8 |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 0.8725 Micrograms per milliliter | Geometric Coefficient of Variation 41 |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 0.2955 Micrograms per milliliter | Geometric Coefficient of Variation 4 |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.3015 Micrograms per milliliter | Geometric Coefficient of Variation 75 |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 1.684 Micrograms per milliliter | Geometric Coefficient of Variation 23 |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 0.2866 Micrograms per milliliter | Geometric Coefficient of Variation 46 |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 0.6904 Micrograms per milliliter | Geometric Coefficient of Variation 55 |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.09913 Micrograms per milliliter | Geometric Coefficient of Variation 36 |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 0.1794 Micrograms per milliliter | Geometric Coefficient of Variation 40 |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.2479 Micrograms per milliliter | Geometric Coefficient of Variation 28 |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 0.9076 Micrograms per milliliter | Geometric Coefficient of Variation 24 |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 0.3998 Micrograms per milliliter | Geometric Coefficient of Variation 41 |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 2.108 Micrograms per milliliter | Geometric Coefficient of Variation 38 |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.5916 Micrograms per milliliter | Geometric Coefficient of Variation 47 |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 3.021 Micrograms per milliliter | Geometric Coefficient of Variation 24 |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 1.473 Micrograms per milliliter | Geometric Coefficient of Variation 79 |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 1.220 Micrograms per milliliter | Geometric Coefficient of Variation 25 |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.8304 Micrograms per milliliter | Geometric Coefficient of Variation 131 |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 2.568 Micrograms per milliliter | Geometric Coefficient of Variation 42 |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 1.605 Micrograms per milliliter | Geometric Coefficient of Variation 182 |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 5.748 Micrograms per milliliter | Geometric Coefficient of Variation 16 |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 7.981 Micrograms per milliliter | Geometric Coefficient of Variation 79 |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 11.92 Micrograms per milliliter | Geometric Coefficient of Variation 28 |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 3.802 Micrograms per milliliter | Geometric Coefficient of Variation 12 |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.9875 Micrograms per milliliter | Geometric Coefficient of Variation 52 |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 0.8266 Micrograms per milliliter | Geometric Coefficient of Variation 66 |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 12.98 Micrograms per milliliter | Geometric Coefficient of Variation 26 |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 3.953 Micrograms per milliliter | Geometric Coefficient of Variation 156 |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 3.620 Micrograms per milliliter | Geometric Coefficient of Variation 53 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 0 Day 1 | 3.639 Micrograms per milliliter | Geometric Coefficient of Variation 21 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 9.927 Micrograms per milliliter | Geometric Coefficient of Variation 18 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 25.74 Micrograms per milliliter | Geometric Coefficient of Variation 19 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 0 Day 1 | 0.9445 Micrograms per milliliter | Geometric Coefficient of Variation 59 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 2.088 Micrograms per milliliter | Geometric Coefficient of Variation 106 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 11.00 Micrograms per milliliter | Geometric Coefficient of Variation 186 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | 5.323 Micrograms per milliliter | Geometric Coefficient of Variation 69 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | 12.03 Micrograms per milliliter | Geometric Coefficient of Variation 67 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 8.710 Micrograms per milliliter | Geometric Coefficient of Variation 54 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 2.485 Micrograms per milliliter | Geometric Coefficient of Variation 91 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 0 Day 1 | 1.087 Micrograms per milliliter | Geometric Coefficient of Variation 79 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 0 Day 1 | 4.216 Micrograms per milliliter | Geometric Coefficient of Variation 42 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 5.513 Micrograms per milliliter | Geometric Coefficient of Variation 141 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 0 Day 1 | 0.5165 Micrograms per milliliter | Geometric Coefficient of Variation 83 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 1.185 Micrograms per milliliter | Geometric Coefficient of Variation 90 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 0 Day 1 | 2.144 Micrograms per milliliter | Geometric Coefficient of Variation 96 |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 1 Day 1 | 2.150 Micrograms per milliliter | Geometric Coefficient of Variation 76 |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 2 Day 1 | NA Micrograms per milliliter | — |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Free PF-06863135: Cycle 0 Day 1 | 0.8080 Micrograms per milliliter | Geometric Coefficient of Variation 59 |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 1 Day 1 | 5.814 Micrograms per milliliter | Geometric Coefficient of Variation 36 |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 | Total PF-06863135: Cycle 0 Day 1 | 2.277 Micrograms per milliliter | Geometric Coefficient of Variation 51 |
Secondary
Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135
Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).
Time frame: From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 63.31 months)
Population: The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 1 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 1 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 1 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 2 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 1 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 1 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 2 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 1 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 1 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 1 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 1 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | ADA positive | 0 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 | NAb positive | 0 Participants |
Secondary
Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 0 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 2 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 0 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 1 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 0 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 2 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 1 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 2 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 0 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 2 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 2 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 3 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 2 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 3 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 8 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 4 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 3 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 6 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 11 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 11 Participants |
Secondary
Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis
Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
Secondary
Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters
Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 1 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 2 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 2 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 2 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 2 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 5 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 5 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 6 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 3 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 4 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 4 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 6 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 6 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 6 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 13 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 4 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 9 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 19 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 29 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 19 Participants |
Secondary
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 2 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 1 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 2 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 0 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 1 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 2 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 1 Participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 3 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 0 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 1 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 2 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 1 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 3 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 2 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 3 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 1 Participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 1 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 2 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 2 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 0 Participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 2 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 2 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 5 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 4 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 1 Participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 3 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 5 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 6 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 6 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 6 Participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 6 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 3 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 4 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 4 Participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 3 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 4 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 1 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 4 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 4 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 4 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 4 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 1 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 3 Participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 3 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 4 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 4 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 3 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 4 Participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 4 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 6 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 4 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 2 Participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 6 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 6 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 5 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 6 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 6 Participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 7 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 3 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 6 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 7 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 3 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 12 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 1 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 9 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 13 Participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 13 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 4 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 2 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 4 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 4 Participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 0 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 9 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 7 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 9 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 8 Participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 2 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 11 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 17 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 23 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 17 Participants |
| Part 1: PF-06863135 Total IV | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 2 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 28 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 24 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 6 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 30 Participants |
| Part 1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 20 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 15 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with AEs | 20 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 4 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious TEAEs | 15 Participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 20 Participants |
Secondary
Part 1: ORR as Per IMWG Criteria
ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by \>=90% or to \<200 mg/24 hr. If serum and urine M-protein were unmeasurable, \>=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: ORR as Per IMWG Criteria | 50.0 Percentage of participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: ORR as Per IMWG Criteria | 75.0 Percentage of participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: ORR as Per IMWG Criteria | 66.7 Percentage of participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: ORR as Per IMWG Criteria | 83.3 Percentage of participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: ORR as Per IMWG Criteria | 57.1 Percentage of participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: ORR as Per IMWG Criteria | 61.5 Percentage of participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: ORR as Per IMWG Criteria | 75.0 Percentage of participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: ORR as Per IMWG Criteria | 77.8 Percentage of participants |
| Part 1: PF-06863135 Total IV | Part 1: ORR as Per IMWG Criteria | 0 Percentage of participants |
| Part 1: PF-06863135 Total SC | Part 1: ORR as Per IMWG Criteria | 46.7 Percentage of participants |
| Part 1.1: PF-06863135 Total SC | Part 1: ORR as Per IMWG Criteria | 60.0 Percentage of participants |
Secondary
Part 1: Overall Survival (OS)
OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.
Time frame: Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 63.31 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Overall Survival (OS) | 8.2 Months |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Overall Survival (OS) | 8.4 Months |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Overall Survival (OS) | 11.2 Months |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Overall Survival (OS) | 8.1 Months |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Overall Survival (OS) | 16.2 Months |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Overall Survival (OS) | 14.8 Months |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Overall Survival (OS) | 18.0 Months |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Overall Survival (OS) | 1.7 Months |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Overall Survival (OS) | NA Months |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Overall Survival (OS) | 19.1 Months |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Overall Survival (OS) | 14.0 Months |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Overall Survival (OS) | 32.9 Months |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Overall Survival (OS) | NA Months |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Overall Survival (OS) | 8.3 Months |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Overall Survival (OS) | NA Months |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Overall Survival (OS) | 31.3 Months |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Overall Survival (OS) | NA Months |
| Part 1: PF-06863135 Total IV | Part 1: Overall Survival (OS) | 12.0 Months |
| Part 1: PF-06863135 Total SC | Part 1: Overall Survival (OS) | 17.3 Months |
| Part 1.1: PF-06863135 Total SC | Part 1: Overall Survival (OS) | NA Months |
Secondary
Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria
MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10\^-5 and 10\^-6.
Time frame: Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first (maximum up to 63.31 months)
Population: Safety Analysis set included all participants who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 50.00 Percentage of participants |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 25.00 Percentage of participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 16.67 Percentage of participants |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 16.67 Percentage of participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 16.67 Percentage of participants |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 16.67 Percentage of participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 28.57 Percentage of participants |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 38.46 Percentage of participants |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 30.77 Percentage of participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 25.00 Percentage of participants |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 Total IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 Total IV | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 0 Percentage of participants |
| Part 1: PF-06863135 Total SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 10.00 Percentage of participants |
| Part 1: PF-06863135 Total SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 13.33 Percentage of participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-6 threshold MRD | 20.00 Percentage of participants |
| Part 1.1: PF-06863135 Total SC | Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria | 10^-5 threshold MRD | 35.00 Percentage of participants |
Secondary
Part 1: Progression Free Survival (PFS) as Per IMWG Criteria
PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates.
Time frame: From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 63.31 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 0.4 Months |
| Part 1: PF-06863135 0.3 mcg/kg IV | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 0.7 Months |
| Part 1: PF-06863135 1 mcg/kg IV | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 1.1 Months |
| Part 1: PF-06863135 3 mcg/kg IV | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 1.7 Months |
| Part 1: PF-06863135 10 mcg/kg IV | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 1.6 Months |
| Part 1: PF-06863135 30 mcg/kg IV | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 1.6 Months |
| Part 1: PF-06863135 50 mcg/kg IV | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 2.9 Months |
| Part 1: PF-06863135 80 mcg/kg SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 1.0 Months |
| Part 1: PF-06863135 130 mcg/kg SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 1.0 Months |
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 19.1 Months |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 10.2 Months |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 32.9 Months |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 8.0 Months |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 7.6 Months |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 12.7 Months |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 18.1 Months |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 6.7 Months |
| Part 1: PF-06863135 Total IV | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 1.4 Months |
| Part 1: PF-06863135 Total SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 4.8 Months |
| Part 1.1: PF-06863135 Total SC | Part 1: Progression Free Survival (PFS) as Per IMWG Criteria | 12.2 Months |
Secondary
Part 1: Time to Response (TTR) as Per IMWG Criteria
TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum& urine & disappearance of soft tissue plasmacytomas & \<5% plasma cells in bone marrow aspirates. VGPR: serum& urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein& reduction in 24hrs urinary M-protein by \>=90% or \<200 mg/24hr. If serum & urine M-protein unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and for arms where it is 0 signifies there was no participant with confirmed objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 215 mcg/kg SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 22.0 Days |
| Part 1: PF-06863135 360 mcg/kg SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 22.0 Days |
| Part 1: PF-06863135 600 mcg/kg SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 22.0 Days |
| Part 1: PF-06863135 1000 mcg/kg SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 42.0 Days |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 39.0 Days |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 36.0 Days |
| Part 1C: PF-06863135 + Lenalidomide SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 52.0 Days |
| Part 1D: PF-06863135 + Pomalidomide SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 50.0 Days |
| Part 1: PF-06863135 Total SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 22.0 Days |
| Part 1.1: PF-06863135 Total SC | Part 1: Time to Response (TTR) as Per IMWG Criteria | 36.0 Days |
Secondary
Part 2: Concentration of Soluble Cytokines in Serum
The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure.
Time frame: Cycle 0 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2); Cycle 1 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2, 72 hours post dose on Day 3)
Population: The PD/Biomarker analysis set included all enrolled participants with at least 1 of the PD/Biomarkers evaluated at pre- and/or post-dose. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 0 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 2 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 4 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 8 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 0; 24 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 0 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 2 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 4 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 8 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 24 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-2: Cycle 1; 72 hours | 2.10 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 0 hours | 2.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 2 hours | 2.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 4 hours | 2.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 8 hours | 2.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 0; 24 hours | 10.30 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 0 hours | 5.05 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 2 hours | 2.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 4 hours | 2.30 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 8 hours | 2.00 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 24 hours | 3.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interleukin-6: Cycle 1; 72 hours | 7.50 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 0 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 2 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 4 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 8 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 0; 24 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 0 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 2 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 4 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 8 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 24 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Interferon-gamma: Cycle 1; 72 hours | 4.20 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 0 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 2 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 4 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 8 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 0; 24 hours | 2.55 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 0 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 2 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 4 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 8 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 24 hours | 1.70 Picogram per milliliter |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Concentration of Soluble Cytokines in Serum | Tumor necrosis factor-alpha: Cycle 1; 72 hours | 1.70 Picogram per milliliter |
Secondary
Part 2: CRR as Per IMWG Criteria
CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates.
Time frame: From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: CRR as Per IMWG Criteria | 33.3 Percentage of participants |
Secondary
Part 2: DoCR as Per IMWG Criteria
DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Time frame: From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 34.3 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: DoCR as Per IMWG Criteria | 9.4 Months |
Secondary
Part 2: DOSD as Per IMWG Criteria
DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum & urine &disappearance of any soft tissue plasmacytomas &\<5% plasma cells in bone marrow aspirates. VGPR: serum & urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp & reduction in 24 hours urinary Mp by \>=90% or\<200 mg/24 hr. If serum & urine Mp were unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Time frame: Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 34.3 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: DOSD as Per IMWG Criteria | 11.6 Months |
Secondary
Part 2: Number of Participants With ADA and NAb Against PF-06863135
Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).
Time frame: From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 34.3 months)
Population: The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With ADA and NAb Against PF-06863135 | ADA positive | 0 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With ADA and NAb Against PF-06863135 | NAb positive | 0 Participants |
Secondary
Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
Population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with TEAEs | 15 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with serious AEs | 12 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with treatment related AEs | 13 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 3 or 4 AEs | 11 Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 | Participants with grade 5 AEs | 3 Participants |
Secondary
Part 2: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
Population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters | 8 Participants |
Secondary
Part 2: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters
Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
Population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters | 15 Participants |
Secondary
Part 2: Number of Participants With Shifts From Grade <=2 to Grade 3 or 4 Post-Baseline in Urinalysis
Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
Population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Number of Participants With Shifts From Grade <=2 to Grade 3 or 4 Post-Baseline in Urinalysis | 0 Participants |
Secondary
Part 2: OS
OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.
Time frame: Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 34.3 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: OS | 12.1 Months |
Secondary
Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria
MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10\^-5 and 10\^-6.
Time frame: Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy whichever occurred first (maximum up to 34.3 months)
Population: Safety Analysis set included all participants who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria | 10^-5 threshold MRD | 33.33 Percentage of Participants |
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria | 10^-6 threshold MRD | 13.33 Percentage of Participants |
Secondary
Part 2: PFS as Per IMWG Criteria
PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates.
Time frame: From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 34.3 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: PFS as Per IMWG Criteria | 10.4 Months |
Secondary
Part 2: TTR as Per IMWG Criteria
TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum& urine & disappearance of soft tissue plasmacytomas & \<5% plasma cells in bone marrow aspirates. VGPR: serum& urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein& reduction in 24hrs urinary M-protein by \>=90% or \<200 mg/24hr. If serum & urine M-protein unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Time frame: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | Part 2: TTR as Per IMWG Criteria | 40.0 Days |