Overview

This trial is active, not recruiting.

Condition newly diagnosed, previously untreated multiple myeloma
Treatments lenalidomide, dexamethasone, elotuzumab
Phase phase 3
Target SLAMF7
Sponsor Bristol-Myers Squibb
Collaborator Abbott
Start date September 2013
End date July 2019
Trial size 750 participants
Trial identifier NCT01891643, 2010-022445-20, CA204-006 (Biomarker Substudy)

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug
lenalidomide Revlimid®
dexamethasone Decadron®
(Experimental)
Lenalidomide 25 mg capsules by mouth once daily (Days 1-21) Dexamethasone 28 mg tablets by mouth once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15(cycles 3-18); Day 1 (cycle 19 & beyond)] Dexamethasone 40 mg tablets by mouth once daily [Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 & beyond)] Dexamethasone 8 mg IV (intravenous) solution once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18); Day 1 (cycle 19 & beyond)] Elotuzumab 10 mg/kg IV solution weekly [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18)] Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 & beyond) Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
lenalidomide Revlimid®
dexamethasone Decadron®
elotuzumab BMS-901608

Primary Outcomes

Measure
Change from baseline to progression of the cell surface expression of CS1 from bone marrow-derived MM cells in both treatment arms
time frame: Screening (up to 30 days prior to first dose) and time of progression (33 months)

Secondary Outcomes

Measure
Level of cell surface CS1 from bone marrow-derived MM cells in both treatment arms
time frame: Time of progression (33 months)
sCS1 levels in serum and to evaluate change from baseline and during therapy and at progression in both treatment arms
time frame: Screening (up to 30 days prior to first dose), Cycle 3 Day 1 and time of progression (33 months)
The presence, and the change from baseline, on therapy, and at progression, of circulating MM cell numbers and their CS1 cell surface expression in both treatment arms
time frame: Screening (up to 30 days prior to first dose), Cycle 3 Day 1 and time of progression (33 months)
The cell number and CS1 expression patterns between matched samples of bone marrow-derived MM cells and circulating MM cells at baseline and at progression in both treatment arms
time frame: Screening (up to 30 days prior to first dose) and time of progression (33 months)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.