Pomalidomide/Dexamethasone With or Without Elotuzumab in Multiple Myeloma that is resistant to treatment.

Phase 1

Conditions: relapsed and refractory Multiple Myeloma
MedDRA version: 18.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-003282-19-GR

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

(1) = 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination.
(2) Documented refractory or relapsed and refractory multiple myeloma
(3) Refractory to proteosome inhibitor and lenalidomide, and to their last treatment
(4) Relapsed and refractory patients had achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment.

(5) Measurable disease at screening

(6) Eastern Cooperative Oncology Group (ECOG) performance status = 2

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 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

(1) Active plasma cell leukemia
(2) Prior treatment with pomalidomide
(3) Unable to tolerate thromboembolic prophylaxis while on the study
(4) Prior autologous stem cell transplant within 12 weeks
(5) Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare progression free survival (PFS) between treatment arms;Secondary Objective: - To compare objective response rate between treatment arms<br>- To compare overall survival between treatment arms;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: PFS will be defined as the time, in months, from randomization to the date of the firstdocumented tumor progression or death due to any cause.Time Frame: Every 4 weeks relative to the first dose of study medication, until progressive disease.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (1) Objective Response Rate (ORR) is defined as the proportion of randomized subjects who achieve a best response of partial response (PR) or better.(2) Overall Survival (OS) defined as the period of time from randomization until the date of death or last known alive date.;Timepoint(s) of evaluation of this end point: (1) ORR - All response endpoints will be assessed every 4 weeks after the start of study therapy, and until progressive disease occurs.<br>(2) OS will be assessed every 12 weeks, or more frequently, in the Follow Up Phase of the trial.

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