DS Stage III Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage I Plasma Cell Myeloma
Conditions
Brief summary
This partially randomized phase I/II trial studies the side effects and best dose of elotuzumab and to see how well it works when given together with lenalidomide, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to block cancer growth.
Detailed description
PRIMARY OBJECTIVES: I. To determine the appropriate Phase II dose of elotuzumab to use in combination with lenalidomide, bortezomib, and dexamethasone for patients with multiple myeloma. (Phase I) II. To assess whether incorporation of the novel agent elotuzumab into the treatment algorithm of high-risk multiple myeloma (HRMM) will improve progression-free survival (PFS). (Phase II) III. To estimate the frequency and severity of toxicities of this treatment strategy in this patient population. (Phase II) OUTLINE: This is a phase I, dose-escalation study of elotuzumab, followed by a phase II, randomized study. PHASE I: INDUCTION: Patients receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I: INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 6 years.
Interventions
DRUGBortezomib
Given SC or IV
DRUGDexamethasone
Given PO or IV
BIOLOGICALElotuzumab
Given IV
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGLenalidomide
Given PO
Sponsors
SWOG Cancer Research Network
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have newly diagnosed active multiple myeloma (MM) * For the Phase II portion only, patients must have high-risk MM based on one or more of the following criteria at the time of initial diagnosis (prior to any chemotherapy): * Poor-risk genomic signature according to the University of Arkansas 70-gene model (available clinically as myeloma prognostic risk score \[MyPRS\] score, Signal Genetics, Inc) AND/OR * Translocation (14;16), and/or translocation (14;20), and/or deletion (17p) by fluorescence in-situ hybridization (FISH) or cytogenetics AND/OR * Primary plasma cell leukemia (defined by either \>= 2,000 plasma cells/mL of peripheral blood, or 20% on a manual differential count) AND/OR * Serum lactate dehydrogenase (LDH) \>= 2 x institutional upper limit of normal (IULN) AND/OR * 1q21 amplification by FISH analysis AND/OR * High risk by the SKY92 signature * Patients with non-secretory MM or known amyloidosis are not eligible * Patients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy) * Patients on the Phase I portion may not have received ANY prior chemotherapy; patients on the Phase II portion may have received one prior cycle of any non-investigational chemotherapy; prior chemotherapy must have been completed within 56 days prior to registration and all toxicities must have resolved to =\< grade 1; patients on either portion may have received prior treatment with dexamethasone, providing total number of days of treatment was =\< 14 days and total treatment dose was =\< 360 mg * Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only; radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to =\< grade 1 * Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 without growth factor support * Platelet count \>= 70,000 cells/mm\^3 for patients who have bone marrow plasmacytosis \< 50%; or \>= 50,000 cells/mm\^3 for patients who have bone marrow plasmacytosis of \>= 50% * Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) * Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =\< 2.5 x IULN * Creatinine clearance (CrCL) \>= 30 mL/min, measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula within 14 days prior to registration * Patients must not have active involvement of the central nervous system (CNS) with MM (by clinical evaluation); patients with documentation of, or clinical signs or symptoms consistent with, CNS involvement of MM must have a lumbar puncture that is negative for CNS involvement of MM; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture prior to registration; note that monitoring of CNS involvement and treatment with intrathecal therapy is recommended during protocol treatment * Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration: * Cluster of differentiation (CD)4 cells \>= 500/mm\^3 * Viral load of \< 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on combination antiretroviral therapy (cART) or \< 25,000 copies HIV mRNA if not on cART * No zidovudine or stavudine as part of cART * Patients who are HIV+ and do not meet all of these criteria are not eligible for this study * Patients must have baseline skeletal survey (whole body x-ray) to document lytic lesions, osteopenia or compression fracture * Patients must have Zubrod performance status =\< 2 * Patients with known hepatitis B or hepatitis C infection may be eligible providing they have viral load \< 800,000 IU/L within 28 days prior to registration * Patients must not have POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled \>= grade 3 cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus; patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration * Uncontrolled diabetes: a glycated hemoglobin (Hg A1C) \> 7% within 14 days prior to registration; the same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months * Uncontrolled blood pressure and hypertension: systolic blood pressure (SBP) \> 140 mm Hg or diastolic blood pressure (DBP) \> 90 mm Hg within 14 days prior to registration; patients are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study); all blood pressure measurements within the 14 days prior to registration and on day 1 of cycle 1 must be SBP =\< 140 and DBP =\< 90; an exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a normal blood pressure * Patients must have history and physical examination within 28 days prior to registration * Patients must not have any psychiatric illness that could potentially interfere with the completion of treatment according to this protocol * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to registration; (Note: that pregnancy testing is also required within 24 hours prior to treatment on cycle 1, day 1); furthermore, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years * Patients must be offered participation in banking of specimens for future research; with the patient's consent, specimens (serum and bone marrow biopsy core) must be submitted to the repository; patient consent must be obtained before specimens are submitted * Patients must be registered to the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)™ program and must be willing and able to comply with the requirements of the Revlimid REMS™ program * Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone | time from first participants randomized until at least 6 patients were evaluable for DLTs. DLTs were assessed only during Cycle 1 (21 days) | Assess safety of elotuzumab in combination with bortezomib, lenalidomide and dexamethasone and select the optimal dose of elotuzumab for the Phase II portion from 10mg/kg on each cycle, to 5mg/kg on each cycle MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 1/6 participants. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 3 nausea or diarrhea despite anti-emetic and anti-diarrheal therapy; grade 3 hyperglycemia if symptomatic or glucose level \> 300mg/ml despite insulin and/or oral diabetic therapy; grade 4 neutropenia ≥ 7 days or grade 3/4 neutropenia with fever (≥ 38.5 oC); grade 4 thrombocytopenia ≥ 7 days or associated with hemorrhage; delay of treatment with any agent by \> 2 weeks due to drug related toxicity. DLT were graded using the NCI CTCAE version 4.0 Note: i) the second, lower dose level was not tested as the first dose level was deemed safe ii) 6 participants were evaluable at phase I analysis |
| Progression-free Survival | Up to 6 years post registration | From date of registration to date of first documentation of progression or death due to any cause. Per the International Uniform Response Criteria for Multiple Myeloma, progression is defined as \>=1 of Serum M protein increase \>= 25% from lowest response level, with an absolute increase of \>= 0.5g/dL; Urine M protein increase \>= 25% from lowest response level, with an absolute increase of \>= 200 mg/24 hrs; If participant had serum M protein \<1 g/dL, urine M protein \<200 mg/24 hrs, and an involved serum free light chain level \>= 10mg/dL at baseline: \>= 25% increase in the difference between involved and uninvolved serum free light chain level with an absolute increase of \>= 10 mg/dL; Bone marrow plasma cell % increase =25% from baseline with the absolute plasma cell % \>=10%; New bone lesions or soft tissue plasmocytomas, or definite increase in size of existing bone lesions or soft tissue plasmocytomas; Development of hypercalcemia that can be attributed solely to multiple myeloma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow up until death or 6 years post registration, whichever occurs first. | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Overall Survival | Up to 6 years post registration | From date of registration to date of death due to any cause |
| Response (Partial Response [PR] or Better) Rate | Up to 6 years post registration | Percentage of participants with PR or better to treatment per the International Uniform Response Criteria for Multiple Myeloma stringent Complete Response- CR criteria + normal serum free light chain (FLC) ratio + absence of clonal cells in bone marrow (BM) by immunohistochemistry or immunofluorescence CR- Negative immunofixation (IFX) on serum \& urine M proteins + \<5% plasma cells in BM + disappearance of soft tissue plasmocytomas (STP) very good PR- PR criteria + serum \& urine M proteins detectable by IFX but not on electrophoresis or \>=90% reduction (RED) in serum M protein \& urine M protein \<100 g/24 hrs PR- \>=50% RED in size of STP, if present at baseline \& \>=50% RED in plasma cells, if \>=30% plasma cells in BM at baseline: \& RED in serum M protein of \>=50% \& in urine M protein of \>= 90% or to 200 mg/24hr OR if serum M protein \<1 g/dL, urine M protein \<200 mg/24 hrs, \& involved serum FLC level \>= 10 mg/dl at baseline: \>= 50% RED in (involved-uninvolved) serum FLC levels |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSaad Usmani
SWOG Cancer Research Network
Participant flow
Pre-assignment details
8 participants were enrolled to the Phase 1 Level 1 dose arm. 2 were ineligible, so 6 participants were assessed for DLT. In Phase II, 68 participants were enrolled on RVD and 66 to RVD/Elo arm. of these, 16 and 18 respectively were ineligible. Thus, 52 participants on RVD and 48 participants on RVD/Elo arm were eligible and evaluable for analyses.
Participants by arm
| Arm | Count |
|---|---|
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) INDUCTION: Participants receive bortezomib subcutaneously (SC) or intravenously (IV) on days 1, 4, 8, and 11; lenalidomide orally (PO) once daily (QD) on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12 (and on day 15 of courses 1 and 2 only). Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; dexamethasone PO on days 1, 8, and 15; and elotuzumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. | 6 |
| Arm I (Bortezomib, Lenalidomide, Dexamethasone) INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy).
MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given SC or IV
Dexamethasone: Given PO or IV
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO | 52 |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE:Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Bortezomib: Given SC or IV
Dexamethasone: Given PO or IV
Elotuzumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Lenalidomide: Given PO | 48 |
| Total | 106 |
Baseline characteristics
| Characteristic | Total | Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Arm I (Bortezomib, Lenalidomide, Dexamethasone) | Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) |
|---|---|---|---|---|
| Age, Continuous | 64.2 years | 62.3 years | 65.6 years | 67.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 45 Participants | 48 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 4 Participants | 0 Participants |
| PCL and/or high LDH No | 90 Participants | 42 Participants | 43 Participants | 5 Participants |
| PCL and/or high LDH Yes | 16 Participants | 6 Participants | 9 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 6 Participants | 8 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 88 Participants | 41 Participants | 44 Participants | 3 Participants |
| Sex: Female, Male Female | 43 Participants | 19 Participants | 21 Participants | 3 Participants |
| Sex: Female, Male Male | 63 Participants | 29 Participants | 31 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 6 | 19 / 52 | 16 / 48 |
| other Total, other adverse events | 6 / 6 | 52 / 52 | 47 / 48 |
| serious Total, serious adverse events | 3 / 6 | 6 / 52 | 24 / 48 |
Outcome results
Primary
Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone
Assess safety of elotuzumab in combination with bortezomib, lenalidomide and dexamethasone and select the optimal dose of elotuzumab for the Phase II portion from 10mg/kg on each cycle, to 5mg/kg on each cycle MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 1/6 participants. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 3 nausea or diarrhea despite anti-emetic and anti-diarrheal therapy; grade 3 hyperglycemia if symptomatic or glucose level \> 300mg/ml despite insulin and/or oral diabetic therapy; grade 4 neutropenia ≥ 7 days or grade 3/4 neutropenia with fever (≥ 38.5 oC); grade 4 thrombocytopenia ≥ 7 days or associated with hemorrhage; delay of treatment with any agent by \> 2 weeks due to drug related toxicity. DLT were graded using the NCI CTCAE version 4.0 Note: i) the second, lower dose level was not tested as the first dose level was deemed safe ii) 6 participants were evaluable at phase I analysis
Time frame: time from first participants randomized until at least 6 patients were evaluable for DLTs. DLTs were assessed only during Cycle 1 (21 days)
Population: At the time of the phase I analysis, six participants were evaluable for DLTs (i.e. were eligible and received at least one dose of study drug).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone | 10 mg/kg (Phase II dosing for elotuzumab) |
Primary
Progression-free Survival
From date of registration to date of first documentation of progression or death due to any cause. Per the International Uniform Response Criteria for Multiple Myeloma, progression is defined as \>=1 of Serum M protein increase \>= 25% from lowest response level, with an absolute increase of \>= 0.5g/dL; Urine M protein increase \>= 25% from lowest response level, with an absolute increase of \>= 200 mg/24 hrs; If participant had serum M protein \<1 g/dL, urine M protein \<200 mg/24 hrs, and an involved serum free light chain level \>= 10mg/dL at baseline: \>= 25% increase in the difference between involved and uninvolved serum free light chain level with an absolute increase of \>= 10 mg/dL; Bone marrow plasma cell % increase =25% from baseline with the absolute plasma cell % \>=10%; New bone lesions or soft tissue plasmocytomas, or definite increase in size of existing bone lesions or soft tissue plasmocytomas; Development of hypercalcemia that can be attributed solely to multiple myeloma
Time frame: Up to 6 years post registration
Population: Eligible and analyzable participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Progression-free Survival | 33.6 months |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Progression-free Survival | 31.5 months |
Secondary
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Duration of treatment and follow up until death or 6 years post registration, whichever occurs first.
Population: Participants who received at least one dose of protocol treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Alanine aminotransferase increased | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyperglycemia | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nausea | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyperkalemia | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Creatinine increased | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypertension | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neuralgia | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypoalbuminemia | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Alkaline phosphatase increased | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypokalemia | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain in extremity | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness trunk | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Peripheral motor neuropathy | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Diarrhea | 5 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Peripheral sensory neuropathy | 4 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Allergic reaction | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Platelet count decreased | 10 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dizziness | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pneumonitis | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neck pain | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Portal vein thrombosis | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dry skin | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pulmonary edema | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Anemia | 8 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash acneiform | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dyspnea | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash maculo-papular | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Abdominal pain | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Resp, thoracic and mediastinal disorders - Other | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Edema limbs | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Respiratory failure | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Aspartate aminotransferase increased | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Sepsis | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Encephalopathy | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Skin infection | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness lower limb | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Eye disorders - Other, specify | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Stroke | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyponatremia | 3 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Atrial fibrillation | 3 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fall | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Supraventricular tachycardia | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Acute kidney injury | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Syncope | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fatigue | 6 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypophosphatemia | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neutrophil count decreased | 8 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypotension | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Back pain | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypoxia | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Osteonecrosis of jaw | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | INR increased | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Musculoskeletal and connective tiss disorder - Other | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infections and infestations - Other, specify | 3 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Blood bilirubin increased | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Thromboembolic event | 4 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infusion related reaction | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Insomnia | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Agitation | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lung infection | 3 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fracture | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lymphocyte count decreased | 14 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Bone pain | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tremor | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Gait disturbance | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urinary tract infection | 2 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Multi-organ failure | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urine output decreased | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Gastrointestinal disorders - Other, specify | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vomiting | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cataract | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Weight loss | 0 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Generalized muscle weakness | 1 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | White blood cell decreased | 4 Participants |
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pneumonitis | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lymphocyte count decreased | 13 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Multi-organ failure | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness lower limb | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness trunk | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Musculoskeletal and connective tiss disorder - Other | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nausea | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Abdominal pain | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Acute kidney injury | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Agitation | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Alanine aminotransferase increased | 2 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Alkaline phosphatase increased | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Allergic reaction | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Anemia | 6 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Aspartate aminotransferase increased | 2 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Atrial fibrillation | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Back pain | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Blood bilirubin increased | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Bone pain | 2 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neck pain | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cataract | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neuralgia | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Creatinine increased | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Diarrhea | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dizziness | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dry skin | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dyspnea | 2 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Edema limbs | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Encephalopathy | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Eye disorders - Other, specify | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fall | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neutrophil count decreased | 5 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Osteonecrosis of jaw | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fatigue | 5 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fracture | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Gait disturbance | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Gastrointestinal disorders - Other, specify | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Generalized muscle weakness | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyperglycemia | 4 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyperkalemia | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypertension | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypoalbuminemia | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain in extremity | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Peripheral motor neuropathy | 4 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Peripheral sensory neuropathy | 6 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Platelet count decreased | 10 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Portal vein thrombosis | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pulmonary edema | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash acneiform | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash maculo-papular | 3 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Resp, thoracic and mediastinal disorders - Other | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Respiratory failure | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Sepsis | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Skin infection | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypokalemia | 4 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Stroke | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hyponatremia | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Supraventricular tachycardia | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Syncope | 2 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypophosphatemia | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypotension | 4 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypoxia | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | INR increased | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infections and infestations - Other, specify | 4 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infusion related reaction | 3 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Insomnia | 2 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lung infection | 5 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Thromboembolic event | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tremor | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urinary tract infection | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urine output decreased | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vomiting | 0 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Weight loss | 1 Participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | White blood cell decreased | 5 Participants |
Secondary
Overall Survival
From date of registration to date of death due to any cause
Time frame: Up to 6 years post registration
Population: Eligible and evaluable participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Overall Survival | NA months |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Overall Survival | 68 months |
Secondary
Response (Partial Response [PR] or Better) Rate
Percentage of participants with PR or better to treatment per the International Uniform Response Criteria for Multiple Myeloma stringent Complete Response- CR criteria + normal serum free light chain (FLC) ratio + absence of clonal cells in bone marrow (BM) by immunohistochemistry or immunofluorescence CR- Negative immunofixation (IFX) on serum & urine M proteins + \<5% plasma cells in BM + disappearance of soft tissue plasmocytomas (STP) very good PR- PR criteria + serum & urine M proteins detectable by IFX but not on electrophoresis or \>=90% reduction (RED) in serum M protein & urine M protein \<100 g/24 hrs PR- \>=50% RED in size of STP, if present at baseline & \>=50% RED in plasma cells, if \>=30% plasma cells in BM at baseline: & RED in serum M protein of \>=50% & in urine M protein of \>= 90% or to 200 mg/24hr OR if serum M protein \<1 g/dL, urine M protein \<200 mg/24 hrs, & involved serum FLC level \>= 10 mg/dl at baseline: \>= 50% RED in (involved-uninvolved) serum FLC levels
Time frame: Up to 6 years post registration
Population: Eligible participants assessable for response at follow up. 1 participant on Arm II was not assessable for RR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | Response (Partial Response [PR] or Better) Rate | 88 Percentage of participants |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | Response (Partial Response [PR] or Better) Rate | 83 Percentage of participants |