BMS CA204007: A Phase 1b Study of Elotuzumab in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma and Normal Renal Function, Severe Renal Impairment, or End Stage Renal Disease Requiring Dialysis

Study Status

Open to Enrollment

Study Description

This clinical trial is testing a new experimental drug called elotuzumab to treat multiple myeloma in men and women who have either normal kidney function, severe kidney impairment, or end-stage kidney disease requiring dialysis.

The purpose of this study is to determine if kidney impairment and end-stage kidney disease affect how your body processes elotuzumab. Earlier studies show that elotuzumab given with lenalidomide and dexamethasone has a favorable safety profile in patients with normal kidney function or mild to moderate kidney impairment. It is unknown whether the same is true for patients who have severe kidney impairment or are dependent on dialysis. This study will also look at the safety of elotuzumab given with lenalidomide and dexamethasone in patients with and without severe kidney impairment and end-stage kidney disease requiring dialysis.

Participants enrolled in the study will receive lenalidomide and dexamethasone with elotuzumab. The study is “open label,” which means you and the study physician will know which drugs you are receiving. There is no placebo used in this study.

Study Treatment (a treatment cycle is 28 days)

Elotuzumab:

  • Cycle 1: Day 1 only via infusion
  • Cycles 2 and 3: Day 1, 8, 15 and 22 via infusion
  • Cycle 4 and after: Day 1 and 15 via infusion

Lenalidomide:

  • All cycles: pills by mouth over a 21-day period every 28 days

Dexamethasone:

  • All weeks when you are receiving elotuzumab: once weekly pills by mouth between 3 and 24 hours after elotuzumab infusion AND a dose intravenously before elotuzumab infusion
  • All weeks you are not receiving elotuzumab: once weekly pills by mouth

Participants will continue treatment as long as their disease does not progress and they do not experience unacceptable side effects.

Disease Status and/or Stage

Multiple Multiple and Normal Renal Function, Severe Renal Impairment, or on Dialysis

Sponsor

Bristol-Myers Squibb

Key Eligibility

  • Men and women age 18 and older
  • Diagnosed with multiple myeloma and renal function fitting one of three categories:
    • Severe renal (kidney) impairment
    • End-stage renal (kidney) disease requiring dialysis
    • Normal renal function
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ruben Niesvizky, MD

Contact

Protocol ID

BMS CA204007


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
erb3001@med.cornell.edu

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