An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 170
- Locations
- 111
- Primary Endpoint
- Progression Free Survival (PFS)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Investigational Arm
Nivolumab, Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Nivolumab (Biological)
Investigational Arm
Nivolumab, Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Pomalidomide (Drug)
Investigational Arm
Nivolumab, Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Dexamethasone (Drug)
Control Arm
Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Pomalidomide (Drug)
Control Arm
Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Dexamethasone (Drug)
Exploratory Arm
Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Nivolumab (Biological)
Exploratory Arm
Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Elotuzumab (Biological)
Exploratory Arm
Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Pomalidomide (Drug)
Exploratory Arm
Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone
Enrollment is closed for this arm
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)
Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
Secondary Outcomes
- Overall Survival (OS)(From randomization to the date of death due to any cause (up to approximately 64 months))
- Duration of Objective Response (DOR)(From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months))
- Objective Response Rate (ORR)(From randomization up to approximately 64 months)
- Time to Objective Response (TTR)(From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months))