Phase 3 Study of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Multiple Myeloma

Phase 1

Conditions: relapsed and refractory Multiple Myeloma
MedDRA version: 19.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-005699-21-NO

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 512

Inclusion Criteria

-Measurable Disease
-Have received= 2 lines of prior therapy which must have included at least 2 consecutive cycles of an immune modulatory drug (IMID) and a proteasome inhibitor alone or in combination.
-Documented progression from most recent therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 154
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 358

Exclusion Criteria

-Solitary bone or extramedullary plasmacytoma disease only
-Active plasma cell leukemia
-monoclonal gammopathy of undetermined significance (MGUS),
smoldering multiple myeloma (SMM), amyloidosis, Waldenstrom’s macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the clinical benefit and safety of the combination therapy of Nivolumab, pomalidomide, and dexamethasone (N-Pd the investigational arms, when compared to pomalidomide and dexamethasone (Pd; the control arm) in subjects with relapsed and refractory multiple myeloma;Secondary Objective: -To assess the time to objective response (TTR) within N-Pd and Pd arms<br>- To assess the duration of objective response (DOR) within N-Pd and Pd arms<br>-To assess ORR and PFS by Investigator within N-Pd and Pd arms;Primary end point(s): 1. Objective response rate (ORR)<br>2.Progression free survival (PFS)<br>;Timepoint(s) of evaluation of this end point: 1.Appromixately 18 months from the time of patient enrollment<br>2. Approximately 23 months from the time of patient enrollment<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.To assess the time to objective response (TTR) <br>2.To assess the duration of objective response (DOR) <br>3.ORR and PFS by Investigator<br><br><br>;Timepoint(s) of evaluation of this end point: 1.Approximately 23months from the time of patient enrollment<br>2.Approximately 23 months from the time of patient enrollment<br>3.Approximately 23 months from the time of patient enrollment<br><br>