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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA204-006 (Biomarker Substudy)  |   NCT01891643

PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Subjects who are newly diagnosed with symptomatic MM and who: - Have not received any prior systemic anti-myeloma therapy - Have measurable disease - And are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject <65 years old. There must be a comorbidity that prevents SCT for a subject <65 years old Exclusion Criteria: - Subjects with non-secretory or oligo-secretory or free light-chain only myeloma - Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions - Monoclonal Gammopathy of Undetermined Significance (MGUS) - Active plasma cell leukemia - Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm 1: Lenalidomide + Dexamethasone

ASSIGNED INTERVENTION
  • Drug: Dexamethasone Drug: Lenalidomide

Study Arms

Experimental: Arm 2: Lenalidomide + Dexamethasone + Elotuzumab

ASSIGNED INTERVENTION
  • Biological: Elotuzumab Drug: Dexamethasone Drug: Lenalidomide