Phase 2
Completed N=320
An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT01592370 ↗Enrolled (actual)
320
Serious AEs
49.1%
Results posted
Feb 2022
Primary outcomePrimary: Number of Participants That Experienced Drug Related Grade 3-4 AEs — 19; 18; 0 Participants
Summary
The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Experienced Drug Related Grade 3-4 AEs |
19; 18; 0 | — |
| PRIMARY Number of Participants That Experienced Drug Related Grade 3-4 SAEs |
28; 8; 3 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver |
3; 1; 4; 1; 0; 2 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid |
14; 19; 15; 11; 13; 9 | — |
| PRIMARY Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort |
2; 5; 13; 2 | — |
| PRIMARY Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort |
2; 4; 10; 6 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology |
0; 0; 3; 1; 2; 2 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver |
0; 0; 0; 0; 1; 3 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid |
3; 1; 8; 3; 1; 1 | — |
| SECONDARY Best Overall Response |
10.4; 13.8; 9.7; 33.8; 34.5; 29.0 | — |
| SECONDARY Best Overall Response - Multiple Myeloma Group |
3.7; 0; 0; 0; 0; 0 | — |
| SECONDARY Duration of Response |
22.83; 24.84; 19.38 | — |
| SECONDARY Duration of Response - Multiple Myeloma Group |
NA | — |
| SECONDARY Progression Free Survival |
6.24; 6.93; 3.02 | — |
| SECONDARY Progression Free Survival Rate |
58.0; 42.4; 50.5; 51.5; 34.3; 32.5 | — |
| SECONDARY Overall Survival |
52.57; 30.39; 14.95 | — |
| SECONDARY Number of Participants With PD-L1 Expression |
25; 26; 16; 16; 14; 20 | — |
| SECONDARY Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score |
8.70; 63.03; -39.49 | — |
| SECONDARY Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort |
3.02; 3.60; 2.83; 3.02; 5.45; 30.85 | — |
| SECONDARY Objective Response Rate in the Nivolumab + Daratumumab Cohort |
66.7; 71.4; 51.2; 36.4 | — |
| SECONDARY Duration of Response in the Nivolumab + Daratumumab Cohort |
NA; NA; 6.70; 12.98 | — |
| SECONDARY Progression Free Survival in the Nivolumab + Daratumumab Cohort |
7.56; 16.95; 7.49; 7.01 | — |
| SECONDARY Cmax in the Nivolumab + Daratumumab Cohort |
— | — |
| SECONDARY Tmax in the Nivolumab + Daratumumab Cohort |
— | — |
| SECONDARY Cmin in the Nivolumab + Daratumumab Cohort |
— | — |
| SECONDARY AUC (0-T) in the Nivolumab + Daratumumab Cohort |
— | — |
| SECONDARY AUC (TAU) in the Nivolumab + Daratumumab Cohort |
— | — |
| SECONDARY End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort |
57.28; 69.59; 175.73; 105.14; 193.38; 208.14 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Have received at least 3 prior lines of therapy, including a proteasome inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease that is double refractory to a PI and IMiD
- More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant)
- Have detectable disease measured by a specific protein in your blood and/or urine
- Must consent to bone marrow aspirate or biopsy.
Exclusion Criteria
- Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation
- Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C
- History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT01592370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.