An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma

Phase 3

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: Nivolumab; Biological: Elotuzumab; Drug: Dexamethasone; Drug: Pomalidomide

• Registration Number: NCT02726581
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-01
• Study Start: 2016-08-10
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-09
• Status Verified: 2023-02
• Results First Submitted: 2023-02-28
• Results First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Results First Posted: 2023-03-27
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exploratory Arm	Elotuzumab	Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Control Arm	Dexamethasone	Pomalidomide and Dexamethasone Enrollment is closed for this arm
Exploratory Arm	Nivolumab	Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Investigational Arm	Nivolumab	Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Investigational Arm	Pomalidomide	Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Control Arm	Pomalidomide	Pomalidomide and Dexamethasone Enrollment is closed for this arm
Investigational Arm	Dexamethasone	Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Exploratory Arm	Dexamethasone	Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
Exploratory Arm	Pomalidomide	Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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 Outcome Measures

Name	Time	Method
Overall Survival (OS)	From randomization to the date of death due to any cause (up to approximately 64 months)	The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
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)	The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor 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.
Objective Response Rate (ORR)	From randomization up to approximately 64 months	The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria.; sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.; CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates.; VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h.; PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.
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)	The time from the date of randomization to the date of the first stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).; sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.; CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates.; VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h.; PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.

Trial Locations

Locations (111)

Local Institution - 0020; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0160; 🇺🇸 Mobile, Alabama, United States

Local Institution - 0163; 🇺🇸 Fayetteville, Arkansas, United States

Local Institution - 0118; 🇺🇸 Bakersfield, California, United States

Local Institution - 0093; 🇺🇸 Corona, California, United States

Local Institution - 0016; 🇺🇸 Fountain Valley, California, United States

Local Institution - 0164; 🇺🇸 La Jolla, California, United States

UC San Diego Moores Cancer Ctr; 🇺🇸 La Jolla, California, United States

Local Institution - 0138; 🇺🇸 Los Angeles, California, United States

Local Institution - 0155; 🇺🇸 Los Angeles, California, United States

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