Multiple Myeloma
Conditions
Keywords
RRMM, Antibodies, monoclonal, Antigens, BCMA, Immunotherapy, Hematologic diseases, Myeloma, Seattle Genetics
Brief summary
This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur. The study will have several parts. In Parts A and B, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works. In Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.
Interventions
DRUGSEA-BCMA
Given into the vein (IV; intravenously)
DRUGdexamethasone
Given by mouth (orally) or by IV
DRUGpomalidomide
Given orally
Sponsors
Seagen Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diagnosis of MM * Must have MM that is relapsed or refractory * Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody * Measurable disease, as defined by at least one of the following: (1) serum M protein 0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain (FLC) 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda FLC ratio. * Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1 * Life expectancy of greater than 3 months in the opinion of the investigator * Adequate hematologic, renal, and hepatic function
Exclusion criteria
* Parts A and D: Prior treatment with a BCMA-directed therapy * History of another malignancy within 3 years * Active cerebral or meningeal disease related to the underlying malignancy * Uncontrolled Grade 3 or higher infection * Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR-T-cell therapy must be completed 8 weeks before first dose of study drug. * Combination therapy only: 1. Known intolerance to corticosteroids 2. Uncontrolled psychoses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months) | An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). |
| Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months) | An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). |
| Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months) | An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). |
| Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months) | An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). |
| Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months) | The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported. |
| Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months) | The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported. |
| Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months) | The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported. |
| Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months) | The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported. |
| Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months) | The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported. |
| Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months) | The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported. |
| Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months) | The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported. |
| Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months) | The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported. |
| Number of Participants With Dose Limiting Toxicities (DLTs): Part A | Cycle 1 (28 days) | The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the safety monitoring committee (SMC) to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death. |
| Number of Participants With DLTs: Part B | Cycle 1 (28 days) | The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death. |
| Number of Participants With DLTs: Part C | Cycle 1 (28 days) | The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death. |
| Number of Participants With DLTs: Part D | Cycle 1 (28 days) | The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR as Per the IMWG Uniform Response Criteria: Part C | 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 37 months) | The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP & reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required. |
| ORR as Per the IMWG Uniform Response Criteria: Part D | 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 20 months) | The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP & reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required. |
| Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | 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 45 months) | BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD & PD per 2016 IMWG. MRD: evaluated using adaptive next generation sequencing(NGS) for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & \<5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP & R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP & UMP are unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator. |
| OS: Part B | From date of start of study treatment until date of death or censoring date (maximum up to 34 months) | OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day). |
| Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | 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 months) | BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD & PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & \<5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP & R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP & UMP are unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator. |
| Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | 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 37 months) | BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD & PD per 2016 IMWG. MRD: evaluated using NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & \<5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP & R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP & UMP are unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator. |
| Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | 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 20 months) | BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD & PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & \<5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP & R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP & UMP are unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator. |
| Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: Part A | From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 45 months) | DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &\<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP & R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. |
| DOR as Per the IMWG Uniform Response Criteria: Part B | From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 34 months) | DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &\<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP & R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. |
| DOR as Per the IMWG Uniform Response Criteria: Part C | From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 37 months) | DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &\<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP & R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. |
| DOR as Per the IMWG Uniform Response Criteria: Part D | From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 20 months) | DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &\<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP & R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. |
| Progression Free Survival (PFS): Part A | From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 45 months) | PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day. |
| PFS: Part B | From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 34 months) | PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day. |
| PFS: Part C | From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 37 months) | PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day. |
| Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 | Area under the observed concentration-time curve from the time of dosing to Day 14 calculated by log-linear trapezoidal approximation. |
| OS: Part C | From date of start of study treatment until date of death or censoring date (maximum up to 37 months) | OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day). |
| OS: Part D | From date of start of study treatment until date of death or censoring date (maximum up to 20 months) | OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day). |
| PFS: Part D | From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 20 months) | PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day. |
| Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A | Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1 | Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation. |
| AUC0-7 of SEA-BCMA: Part B | Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1 | Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation. |
| AUC0-7 of SEA-BCMA: Part C | Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1 | Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation. |
| AUC0-7 of SEA-BCMA: Part D | Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1 | Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation. |
| Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15 | — |
| Cmax of SEA-BCMA: Part B | Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15 | — |
| Cmax of SEA-BCMA: Part C | Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15 | — |
| Cmax of SEA-BCMA: Part D | Cycle 1:Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15 | — |
| Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A | Anytime during study (maximum up to 45 months) | A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result. |
| Number of Participants With SEA-BCMA, ATA: Part B | Anytime during study (maximum up to 34 months) | A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result. |
| Number of Participants With SEA-BCMA, ATA: Part C | Anytime during study (maximum up to 37 months) | A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result. |
| Number of Participants With SEA-BCMA, ATA: Part D | Anytime during study (maximum up to 20 months) | A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result. |
| Overall Survival (OS): Part A | From date of start of study treatment until date of death or censoring date (maximum up to 45 months) | OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day). |
| Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A | 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 45 months) | ORR: Percentage of participants with an objective response (OR) per investigator. Participant was determined to have an OR if, based on 2016 IMWG uniform response criteria, & achieved stringent complete response (sCR), Complete response (CR), very good partial response(VGPR) & partial response(PR): free light chain(FLC) ratio & absence of clonal cells in bone marrow by immunohistochemistry(IC)/ immunofluorescence(IF). CR: negative immunofixation of serum & urine, disappearance of any soft tissue plasmacytomas(STP), 5% plasma cells in bone marrow. VGPR: serum & urine M-protein (UMP) detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in serum M-protein (SMP) level+UMP level \<100 mg/24 hr, PR: \>=50% reduction of SMP & reduction in 24-hr urinary M-protein by \>=90%/to \<200 mg/24 hr. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. |
| ORR as Per the IMWG Uniform Response Criteria: Part B | 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 months) | The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP & reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required. |
Countries
United States
Participant flow
Recruitment details
A total of 106 participants signed the informed consent form. 15 participants were screen failures, 8 were not assigned to receive study treatment and 83 participants received at least 1 dose of study treatment.
Pre-assignment details
This study had following parts: Part A (SEA-\[B-cell maturation antigen\] BCMA) monotherapy, Part B (SEA-BCMA monotherapy intensive dosing), Part C (SEA-BCMA and dexamethasone combination) and Part D (SEA-BCMA, pomalidomide and dexamethasone combination).
Participants by arm
| Arm | Count |
|---|---|
| Part A: SEA-BCMA 100mg Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV 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 occurs first. | 2 |
| Part A: SEA-BCMA 200mg Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV 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 occurs first. | 2 |
| Part A: SEA-BCMA 400mg Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV 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 occurs first. | 2 |
| Part A: SEA-BCMA 800mg Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV 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 occurs first. | 7 |
| Part A: SEA-BCMA 1600mg Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV 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 occurs first. | 22 |
| Part B: SEA-BCMA 1600mg Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first. | 20 |
| Part C: SEA-BCMA 1600mg and Dexamethasone Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion 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 occurs first. | 12 |
| Part C: SEA-BCMA 800mg and Dexamethasone Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion 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 occurs first. | 6 |
| Part C: SEA-BCMA 1600 mg and Dexamethasone Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion 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 occurs first. | 5 |
| Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first. | 5 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A | Death | 1 | 1 | 2 | 4 | 11 | 0 | 0 | 0 | 0 | 0 |
| Part A | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part A | Other | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Part A | Study terminated by sponsor | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part A | Withdrawal by Subject | 1 | 1 | 0 | 1 | 7 | 0 | 0 | 0 | 0 | 0 |
| Part B | Death | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Part B | Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 12 | 0 | 0 | 0 | 0 |
| Part B | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 |
| Part C | Death | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 1 | 2 | 0 |
| Part C | Other | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Part C | Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 2 | 0 |
| Part C | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 0 |
| Part D | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Part D | Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Part A: SEA-BCMA 100mg | Part A: SEA-BCMA 200mg | Part A: SEA-BCMA 400mg | Part A: SEA-BCMA 800mg | Part A: SEA-BCMA 1600mg | Part B: SEA-BCMA 1600mg | Part C: SEA-BCMA 1600mg and Dexamethasone | Part C: SEA-BCMA 800mg and Dexamethasone | Part C: SEA-BCMA 1600 mg and Dexamethasone | Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 68.5 Years STANDARD_DEVIATION 2.1 | 70.0 Years STANDARD_DEVIATION 7.1 | 72.5 Years STANDARD_DEVIATION 9.2 | 64.3 Years STANDARD_DEVIATION 10.6 | 73.3 Years STANDARD_DEVIATION 7.9 | 73.2 Years STANDARD_DEVIATION 8.9 | 66.9 Years STANDARD_DEVIATION 8.5 | 74.3 Years STANDARD_DEVIATION 6.5 | 72.6 Years STANDARD_DEVIATION 3.9 | 71.2 Years STANDARD_DEVIATION 6.6 | 71.3 Years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 2 Participants | 6 Participants | 18 Participants | 19 Participants | 10 Participants | 5 Participants | 4 Participants | 4 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 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 |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 13 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 |
| 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 2 Participants | 4 Participants | 19 Participants | 17 Participants | 9 Participants | 6 Participants | 3 Participants | 5 Participants | 66 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 10 Participants | 7 Participants | 7 Participants | 2 Participants | 2 Participants | 2 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 0 Participants | 5 Participants | 12 Participants | 13 Participants | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 47 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 1 / 2 | 2 / 2 | 4 / 7 | 11 / 22 | 2 / 20 | 6 / 12 | 1 / 6 | 2 / 5 | 1 / 5 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 2 / 2 | 6 / 7 | 18 / 22 | 17 / 20 | 10 / 12 | 5 / 6 | 5 / 5 | 5 / 5 |
| serious Total, serious adverse events | 1 / 2 | 1 / 2 | 2 / 2 | 3 / 7 | 8 / 22 | 5 / 20 | 5 / 12 | 3 / 6 | 2 / 5 | 3 / 5 |
Outcome results
Primary
Number of Participants With DLTs: Part B
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Time frame: Cycle 1 (28 days)
Population: The DE analysis set included treated participants who either experienced a DLT, or were followed up for the full DLT evaluation period and received at least 75% of the intended total Cycle 1 SEA-BCMA dose, and did not receive prohibited treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With DLTs: Part B | 0 Participants |
Primary
Number of Participants With DLTs: Part C
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Time frame: Cycle 1 (28 days)
Population: The DE analysis set included treated participants who either experienced a DLT, or were followed up for the full DLT evaluation period and received at least 75% of the intended total Cycle 1 SEA-BCMA dose, and did not receive prohibited treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With DLTs: Part C | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With DLTs: Part C | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With DLTs: Part C | 0 Participants |
Primary
Number of Participants With DLTs: Part D
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Time frame: Cycle 1 (28 days)
Population: The DE analysis set included treated participants who either experienced a DLT, or were followed up for the full DLT evaluation period and received at least 75% of the intended total Cycle 1 SEA-BCMA dose, and did not receive prohibited treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With DLTs: Part D | 0 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs): Part A
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE \>=Grade 3, unless deemed by the safety monitoring committee (SMC) to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Time frame: Cycle 1 (28 days)
Population: The DLT-evaluable (DE) analysis set included treated participants who either experienced a DLT, or were followed up for the full DLT evaluation period and received at least 75% of the intended total Cycle 1 SEA-BCMA dose, and did not receive prohibited treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Dose Limiting Toxicities (DLTs): Part A | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Dose Limiting Toxicities (DLTs): Part A | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Dose Limiting Toxicities (DLTs): Part A | 0 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Dose Limiting Toxicities (DLTs): Part A | 1 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Dose Limiting Toxicities (DLTs): Part A | 0 Participants |
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 2 | 0 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 4 | 1 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 1 | 0 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 3 | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 2 | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 4 | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 1 | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 3 | 1 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 1 | 1 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 2 | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 3 | 1 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 4 | 0 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 4 | 2 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 3 | 4 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 2 | 1 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 1 | 0 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 2 | 12 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 4 | 1 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 3 | 9 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A | Grade 1 | 0 Participants |
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B | Grade 1 | 6 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B | Grade 2 | 6 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B | Grade 3 | 7 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B | Grade 4 | 1 Participants |
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 1 | 1 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 2 | 3 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 3 | 4 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 4 | 4 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 4 | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 1 | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 3 | 2 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 2 | 3 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 4 | 1 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 2 | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 3 | 3 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C | Grade 1 | 1 Participants |
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D | Grade 1 | 0 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D | Grade 2 | 2 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D | Grade 3 | 1 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D | Grade 4 | 2 Participants |
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 2 | 0 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 4 | 2 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 3 | 0 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 1 | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 2 | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 4 | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 3 | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 1 | 1 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 1 | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 2 | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 4 | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 3 | 2 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 3 | 2 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 2 | 3 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 1 | 1 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 4 | 1 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 4 | 0 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 1 | 4 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 2 | 7 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A | Grade 3 | 11 Participants |
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B | Grade 3 | 6 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B | Grade 4 | 1 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B | Grade 1 | 5 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B | Grade 2 | 8 Participants |
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 1 | 0 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 2 | 5 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 3 | 5 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 4 | 2 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 4 | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 1 | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 3 | 3 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 2 | 1 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 4 | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 2 | 2 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 3 | 2 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C | Grade 1 | 1 Participants |
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D | Grade 3 | 3 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D | Grade 4 | 0 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D | Grade 1 | 1 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D | Grade 2 | 1 Participants |
Primary
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B | TEAEs | 19 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B | TESAEs | 5 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B | Treatment Related TEAEs | 7 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B | TEAEs (>= Grade 3) | 6 Participants |
Primary
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TEAEs | 11 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TESAEs | 5 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | Treatment Related TEAEs | 4 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TEAEs (>= Grade 3) | 8 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TEAEs (>= Grade 3) | 5 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TEAEs | 6 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | Treatment Related TEAEs | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TESAEs | 3 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TEAEs (>= Grade 3) | 3 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TESAEs | 2 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | Treatment Related TEAEs | 3 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C | TEAEs | 5 Participants |
Primary
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D | TEAEs | 5 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D | TESAEs | 3 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D | Treatment Related TEAEs | 3 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D | TEAEs (>= Grade 3) | 3 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | Treatment Related TEAEs | 0 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs | 2 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs (>= Grade 3) | 1 Participants |
| Part A: SEA-BCMA 100mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TESAEs | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | Treatment Related TEAEs | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TESAEs | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs (>= Grade 3) | 1 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs | 2 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs | 2 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs (>= Grade 3) | 2 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TESAEs | 2 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | Treatment Related TEAEs | 1 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs | 6 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TESAEs | 3 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | Treatment Related TEAEs | 4 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs (>= Grade 3) | 4 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TESAEs | 8 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs | 20 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | TEAEs (>= Grade 3) | 13 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A | Treatment Related TEAEs | 13 Participants |
Secondary
Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A
Area under the observed concentration-time curve from the time of dosing to Day 14 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 2 | 244.8 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 15.4 |
| Part A: SEA-BCMA 100mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 1 | 181.3 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 20 |
| Part A: SEA-BCMA 200mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 1 | 302.6 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 14.6 |
| Part A: SEA-BCMA 200mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 2 | 436.0 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 10.6 |
| Part A: SEA-BCMA 400mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 1 | 977.2 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 37 |
| Part A: SEA-BCMA 400mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 2 | 2216.4 Day*micrograms per milliliter (ug/mL) | — |
| Part A: SEA-BCMA 800mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 1 | 1443.2 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 23.9 |
| Part A: SEA-BCMA 800mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 2 | 2387.9 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 41.4 |
| Part A: SEA-BCMA 1600mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 1 | 3267.7 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 26.8 |
| Part A: SEA-BCMA 1600mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A | Cycle 2 | 5972.1 Day*micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 61 |
Secondary
Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A | 112.6 Day*ug/mL | Geometric Coefficient of Variation 17.6 |
| Part A: SEA-BCMA 200mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A | 197.6 Day*ug/mL | Geometric Coefficient of Variation 11.1 |
| Part A: SEA-BCMA 400mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A | 626.5 Day*ug/mL | Geometric Coefficient of Variation 26.3 |
| Part A: SEA-BCMA 800mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A | 932.0 Day*ug/mL | Geometric Coefficient of Variation 22.1 |
| Part A: SEA-BCMA 1600mg | Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A | 2064.5 Day*ug/mL | Geometric Coefficient of Variation 23.4 |
Secondary
AUC0-7 of SEA-BCMA: Part B
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | AUC0-7 of SEA-BCMA: Part B | 2001.3 Day*ug/mL | Geometric Coefficient of Variation 26.4 |
Secondary
AUC0-7 of SEA-BCMA: Part C
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | AUC0-7 of SEA-BCMA: Part C | 2011.8 Day*ug/mL | Geometric Coefficient of Variation 32.9 |
| Part A: SEA-BCMA 200mg | AUC0-7 of SEA-BCMA: Part C | 840.3 Day*ug/mL | Geometric Coefficient of Variation 21.2 |
| Part A: SEA-BCMA 400mg | AUC0-7 of SEA-BCMA: Part C | 1629.3 Day*ug/mL | Geometric Coefficient of Variation 20.9 |
Secondary
AUC0-7 of SEA-BCMA: Part D
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | AUC0-7 of SEA-BCMA: Part D | 1926.2 Day*ug/mL |
Secondary
Cmax of SEA-BCMA: Part B
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Cmax of SEA-BCMA: Part B | 493.3 ug/mL | Geometric Coefficient of Variation 27.7 |
Secondary
Cmax of SEA-BCMA: Part C
Time frame: Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Cmax of SEA-BCMA: Part C | 471.5 ug/mL | Geometric Coefficient of Variation 72.3 |
| Part A: SEA-BCMA 200mg | Cmax of SEA-BCMA: Part C | 204.2 ug/mL | Geometric Coefficient of Variation 27.3 |
| Part A: SEA-BCMA 400mg | Cmax of SEA-BCMA: Part C | 486.4 ug/mL | Geometric Coefficient of Variation 17.9 |
Secondary
Cmax of SEA-BCMA: Part D
Time frame: Cycle 1:Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Cmax of SEA-BCMA: Part D | 415.1 ug/mL | Geometric Coefficient of Variation 31.8 |
Secondary
DOR as Per the IMWG Uniform Response Criteria: Part B
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &\<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP & R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Time frame: From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 34 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | DOR as Per the IMWG Uniform Response Criteria: Part B | 8.4 Months |
Secondary
DOR as Per the IMWG Uniform Response Criteria: Part C
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &\<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP & R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Time frame: From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | DOR as Per the IMWG Uniform Response Criteria: Part C | NA Months |
| Part A: SEA-BCMA 200mg | DOR as Per the IMWG Uniform Response Criteria: Part C | NA Months |
| Part A: SEA-BCMA 400mg | DOR as Per the IMWG Uniform Response Criteria: Part C | 6.5 Months |
Secondary
DOR as Per the IMWG Uniform Response Criteria: Part D
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &\<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP & R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Time frame: From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | DOR as Per the IMWG Uniform Response Criteria: Part D | 8.3 Months |
Secondary
Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: Part A
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &\<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hour, PR: \>=50%R of SMP & R in 24-hour UMP by \>=90% or to \<200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
Time frame: From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 1600mg | Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: Part A | 10.0 Months |
Secondary
Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A
Time frame: Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SEA-BCMA 100mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 2 | 44.9 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 3.6 |
| Part A: SEA-BCMA 100mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 1 | 28.5 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 32.3 |
| Part A: SEA-BCMA 200mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 1 | 47.2 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 3.9 |
| Part A: SEA-BCMA 200mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 2 | 62.4 Micrograms per milliliter (ug/mL) | — |
| Part A: SEA-BCMA 400mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 1 | 134.8 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 11.6 |
| Part A: SEA-BCMA 400mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 2 | 213.1 Micrograms per milliliter (ug/mL) | — |
| Part A: SEA-BCMA 800mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 1 | 236.4 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 14.4 |
| Part A: SEA-BCMA 800mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 2 | 307.4 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 34.1 |
| Part A: SEA-BCMA 1600mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 1 | 494.6 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 20.3 |
| Part A: SEA-BCMA 1600mg | Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A | Cycle 2 | 746.6 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 29.7 |
Secondary
Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Time frame: Anytime during study (maximum up to 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A | 0 Participants |
| Part A: SEA-BCMA 800mg | Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A | 0 Participants |
| Part A: SEA-BCMA 1600mg | Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A | 0 Participants |
Secondary
Number of Participants With SEA-BCMA, ATA: Part B
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Time frame: Anytime during study (maximum up to 34 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With SEA-BCMA, ATA: Part B | 0 Participants |
Secondary
Number of Participants With SEA-BCMA, ATA: Part C
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Time frame: Anytime during study (maximum up to 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With SEA-BCMA, ATA: Part C | 0 Participants |
| Part A: SEA-BCMA 200mg | Number of Participants With SEA-BCMA, ATA: Part C | 0 Participants |
| Part A: SEA-BCMA 400mg | Number of Participants With SEA-BCMA, ATA: Part C | 0 Participants |
Secondary
Number of Participants With SEA-BCMA, ATA: Part D
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Time frame: Anytime during study (maximum up to 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Number of Participants With SEA-BCMA, ATA: Part D | 0 Participants |
Secondary
Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A
ORR: Percentage of participants with an objective response (OR) per investigator. Participant was determined to have an OR if, based on 2016 IMWG uniform response criteria, & achieved stringent complete response (sCR), Complete response (CR), very good partial response(VGPR) & partial response(PR): free light chain(FLC) ratio & absence of clonal cells in bone marrow by immunohistochemistry(IC)/ immunofluorescence(IF). CR: negative immunofixation of serum & urine, disappearance of any soft tissue plasmacytomas(STP), 5% plasma cells in bone marrow. VGPR: serum & urine M-protein (UMP) detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in serum M-protein (SMP) level+UMP level \<100 mg/24 hr, PR: \>=50% reduction of SMP & reduction in 24-hr urinary M-protein by \>=90%/to \<200 mg/24 hr. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were 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 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A | 0 Percentage of participants |
| Part A: SEA-BCMA 800mg | Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A | 0 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A | 14 Percentage of participants |
Secondary
ORR as Per the IMWG Uniform Response Criteria: Part B
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP & reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
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 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: SEA-BCMA 100mg | ORR as Per the IMWG Uniform Response Criteria: Part B | 20 Percentage of participants |
Secondary
ORR as Per the IMWG Uniform Response Criteria: Part C
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP & reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
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 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: SEA-BCMA 100mg | ORR as Per the IMWG Uniform Response Criteria: Part C | 17 Percentage of participants |
| Part A: SEA-BCMA 200mg | ORR as Per the IMWG Uniform Response Criteria: Part C | 33 Percentage of participants |
| Part A: SEA-BCMA 400mg | ORR as Per the IMWG Uniform Response Criteria: Part C | 20 Percentage of participants |
Secondary
ORR as Per the IMWG Uniform Response Criteria: Part D
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis/ \>= 90% reduction in SMP level+UMP level \<100 mg/24 hour, PR: \>=50% reduction of SMP & reduction in 24-hour urinary M-protein by \>=90%/to \<200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, \>=50% reduction in the size of STP were also required.
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 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: SEA-BCMA 100mg | ORR as Per the IMWG Uniform Response Criteria: Part D | 80 Percentage of participants |
Secondary
OS: Part B
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 34 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | OS: Part B | NA Months |
Secondary
OS: Part C
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | OS: Part C | 18.0 Months |
| Part A: SEA-BCMA 200mg | OS: Part C | NA Months |
| Part A: SEA-BCMA 400mg | OS: Part C | 12.2 Months |
Secondary
OS: Part D
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | OS: Part D | NA Months |
Secondary
Overall Survival (OS): Part A
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
Time frame: From date of start of study treatment until date of death or censoring date (maximum up to 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Overall Survival (OS): Part A | 9.2 Months |
| Part A: SEA-BCMA 200mg | Overall Survival (OS): Part A | 37.5 Months |
| Part A: SEA-BCMA 400mg | Overall Survival (OS): Part A | 8.1 Months |
| Part A: SEA-BCMA 800mg | Overall Survival (OS): Part A | 19.2 Months |
| Part A: SEA-BCMA 1600mg | Overall Survival (OS): Part A | 19.7 Months |
Secondary
Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD & PD per 2016 IMWG. MRD: evaluated using adaptive next generation sequencing(NGS) for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & \<5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP & R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP & UMP are unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
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 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stable disease (SD) | 50 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Partial response (PR) | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Progressive disease (DP) | 50 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stringent complete response (sCR) | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal Residual Disease (MRD)-negative complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal response (MR) | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Very good partial response (VGPR) | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Very good partial response (VGPR) | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal Residual Disease (MRD)-negative complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stringent complete response (sCR) | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Partial response (PR) | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stable disease (SD) | 100 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal response (MR) | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Progressive disease (DP) | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Partial response (PR) | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Progressive disease (DP) | 100 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stable disease (SD) | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal Residual Disease (MRD)-negative complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal response (MR) | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Very good partial response (VGPR) | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stringent complete response (sCR) | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 800mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal response (MR) | 0 Percentage of participants |
| Part A: SEA-BCMA 800mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 800mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stringent complete response (sCR) | 0 Percentage of participants |
| Part A: SEA-BCMA 800mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stable disease (SD) | 86 Percentage of participants |
| Part A: SEA-BCMA 800mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Partial response (PR) | 0 Percentage of participants |
| Part A: SEA-BCMA 800mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Progressive disease (DP) | 14 Percentage of participants |
| Part A: SEA-BCMA 800mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Very good partial response (VGPR) | 0 Percentage of participants |
| Part A: SEA-BCMA 800mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal Residual Disease (MRD)-negative complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Very good partial response (VGPR) | 5 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stringent complete response (sCR) | 0 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal Residual Disease (MRD)-negative complete response (CR) | 0 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Stable disease (SD) | 45 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Progressive disease (DP) | 36 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Minimal response (MR) | 5 Percentage of participants |
| Part A: SEA-BCMA 1600mg | Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A | Partial response (PR) | 9 Percentage of participants |
Secondary
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD & PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & \<5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP & R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP & UMP are unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
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 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | MRD-negative CR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | sCR | 5 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | CR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | VGPR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | PR | 15 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | MR | 5 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | SD | 55 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B | DP | 15 Percentage of participants |
Secondary
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD & PD per 2016 IMWG. MRD: evaluated using NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & \<5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP & R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP & UMP are unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
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 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | DP | 17 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | MR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | VGPR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | PR | 8 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | sCR | 8 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | MRD-negative CR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | SD | 67 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | CR | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | VGPR | 17 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | MRD-negative CR | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | sCR | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | CR | 0 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | PR | 17 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | MR | 17 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | SD | 33 Percentage of participants |
| Part A: SEA-BCMA 200mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | DP | 17 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | CR | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | MRD-negative CR | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | MR | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | sCR | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | VGPR | 0 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | DP | 20 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | SD | 60 Percentage of participants |
| Part A: SEA-BCMA 400mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C | PR | 20 Percentage of participants |
Secondary
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD & PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & \<5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ \>= 90% reduction(R) in SMP level+UMP level \<100 mg/24 hr, PR: \>=50% R of SMP & R in 24-hr UMP by \>=90%/by \<200 mg/24 hr. If SMP & UMP are unmeasurable, \>=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
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 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | sCR | 40 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | MRD-negative CR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | CR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | VGPR | 20 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | PR | 20 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | MR | 0 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | SD | 20 Percentage of participants |
| Part A: SEA-BCMA 100mg | Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D | DP | 0 Percentage of participants |
Secondary
PFS: Part B
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
Time frame: From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 34 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | PFS: Part B | 1.7 Months |
Secondary
PFS: Part C
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
Time frame: From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 37 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | PFS: Part C | 1.6 Months |
| Part A: SEA-BCMA 200mg | PFS: Part C | 3.2 Months |
| Part A: SEA-BCMA 400mg | PFS: Part C | 3.5 Months |
Secondary
PFS: Part D
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
Time frame: From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 20 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | PFS: Part D | 10.1 Months |
Secondary
Progression Free Survival (PFS): Part A
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
Time frame: From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 45 months)
Population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A: SEA-BCMA 100mg | Progression Free Survival (PFS): Part A | 1.7 Months |
| Part A: SEA-BCMA 200mg | Progression Free Survival (PFS): Part A | 5.9 Months |
| Part A: SEA-BCMA 400mg | Progression Free Survival (PFS): Part A | 0.7 Months |
| Part A: SEA-BCMA 800mg | Progression Free Survival (PFS): Part A | 4.4 Months |
| Part A: SEA-BCMA 1600mg | Progression Free Survival (PFS): Part A | 2.1 Months |