Overview

This trial is active, not recruiting.

Conditions lymphoma (myeloma), multiple myeloma
Treatments lenalidomide, dexamethasone, dexamethasone (oral), dexamethasone (iv), elotuzumab (bms-901608; huluc63)
Phase phase 3
Sponsor Bristol-Myers Squibb
Collaborator AbbVie
Start date March 2011
End date September 2014
Trial size 640 participants
Trial identifier NCT01239797, 2010-020347-12, CA204-004

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 (oral) Decadron®
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug. On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone (iv) Decadron®
On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug
elotuzumab (bms-901608; huluc63)
Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 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: Tumor assessments every 4 weeks (±1 week) relative to the first dose of study medication (median length of time for tumor assessments should be approximately 13 months)
Objective response rate (ORR) of Elotuzumab and Lenalidomide / low-dose Dexamethasone
time frame: Approximately up to 6.75 years

Secondary Outcomes

Measure
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 12 weeks in the Follow Up Phase of the trial (approximate length of the overall survival period is 6.75 years)
Change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference using the Brief Pain Inventory-Short Form (BPI-SF) of LdE versus Ld
time frame: Approximately up to 6.75 years

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: - Documented progression from most recent line of therapy - 1-3 prior lines of therapy - Measurable disease - Life expectancy ≥3 months - Prior treatment with Lenalidomide permitted if: 1. Best response achieved was ≥Partial Response (PR) 2. Patient was not refractory 3. Patient did not discontinue due to a Grade ≥3 related adverse event 4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression Exclusion Criteria: - Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma - Active plasma cell leukemia - Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Additional Information

Official title Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.
Location data was received from the National Cancer Institute and was last updated in April 2016.