Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments lenalidomide, dexamethasone, elotuzumab (bms-901608; huluc63)
Phase phase 3
Sponsor Bristol-Myers Squibb
Collaborator AbbVie
Start date May 2011
End date April 2018
Trial size 750 participants
Trial identifier NCT01335399, 2010-022445-20, CA204-006

Summary

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

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 treatment
Arm
(Active Comparator)
lenalidomide Revlimid®
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
(Experimental)
lenalidomide Revlimid®
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
elotuzumab (bms-901608; huluc63)
Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
elotuzumab (bms-901608; huluc63)
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Primary Outcomes

Measure
Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment.
time frame: Every 4 weeks (-1/+3 days) relative to the first dose of study medication.

Secondary Outcomes

Measure
Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy.
time frame: All response endpoints assessed every 4 weeks (-1/+3 days).
Overall Survival - The period of time from study entry until the date of death or last known date alive.
time frame: Survival will be assessed every 16 weeks in the Follow Up Phase of the trial.

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 Multiple Myeloma (MM) and who: - have not received any prior systemic anti-myeloma therapy AND - 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 CA204006 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 November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.