Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments lenalidomide, dexamethasone, elotuzumab (bms-901608)
Phase phase 2
Target SLAMF7
Sponsor Bristol-Myers Squibb
Collaborator AbbVie
Start date January 2015
End date February 2017
Trial size 80 participants
Trial identifier NCT02272803, CA204-116

Summary

The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Drug: Lenalidomide Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug Drug: Dexamethasone Tablets, Oral 28 mg and 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 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 Biological: Elotuzumab (BMS-901608) 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 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
lenalidomide
dexamethasone
elotuzumab (bms-901608)
(Active Comparator)
Drug: Lenalidomide Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug Drug: Dexamethasone Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
lenalidomide
dexamethasone

Primary Outcomes

Measure
Objective Response Rate (ORR) - The percentage of patients who have a partial or better response to Lenalidomide/Dexamethasone + Elotuzumab therapy
time frame: Approximately 24 months

Secondary Outcomes

Measure
The difference in ORR between Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone therapy
time frame: Approximately 24 months

Eligibility Criteria

Male or female participants at least 20 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Newly diagnosed with symptomatic Multiple Myeloma (MM) - Have not received any prior systemic anti-myeloma therapy - Have measurable disease - 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 CA204-116 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old Exclusion Criteria: - Non-secretory 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 2, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma in Japan
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.