Phase 3
Completed N=170
An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma
Source: ClinicalTrials.gov NCT02726581 ↗Enrolled (actual)
170
Serious AEs
66.7%
Results posted
Mar 2023
Primary outcomePrimary: Progression Free Survival (PFS) — 8.38; 7.33 Months
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either:
Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone.
Enrollment is closed for all groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
8.38; 7.33 | — |
| SECONDARY Overall Survival (OS) |
24.87; 21.39 | — |
| SECONDARY Objective Response Rate (ORR) |
48.0; 54.9 | — |
| SECONDARY Time to Objective Response (TTR) |
5.91; 4.37 | — |
| SECONDARY Duration of Objective Response (DOR) |
8.51; 6.47 | — |
Eligibility Criteria
Inclusion Criteria
- Refractory or relapsed and refractory multiple myeloma
- Measurable disease
- Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination
Exclusion Criteria
- Solitary bone or extramedullary plasmacytoma disease only
- Active plasma cell leukemia
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02726581). 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.