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

Phase 1

Conditions: relapsed and refractory Multiple Myeloma
MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-005699-21-IT

Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

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: 1
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: valutare il beneficio clinico e la sicurezza della combinazione terapeutica di Nivolumab, Pomalidomide e Desametasone (N-PD braccio investigativo) paragonato al braccio di controllo ( Pd-Pomalidomide e desametasone) in soggetti con mieloma multiplo recidivato e refrattario;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<br>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);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

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;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