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Active, Not Recruiting

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma - CA204-004

Updated: 31 October, 2018   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Active Comparator: Lenalidomide + Dexamethasone
Drug: Lenalidomide Drug: Dexamethasone
Experimental: Lenalidomide + Dexamethasone +Elotuzumab
Drug: Lenalidomide Drug: Dexamethasone (Oral) Drug: Dexamethasone (IV) Biological: Elotuzumab (BMS-901608; HuLuc63)

Key Eligibility Criteria

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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com