Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.

Key facts

Study ID

NCT01393964

Run by

Bristol-Myers Squibb

People needed

35

Starts

2012-01-06

Expected to finish

2016-07-18

Last updated by the study team

2017-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with Multiple Myeloma (MM) and renal function fitting one of three categories:
• Severe renal impairment: estimated creatinine clearance (CrCl) <30 ml/min, but not requiring dialysis
• End-stage renal disease: requiring hemodialysis
• Normal renal function: estimated CrCl ≥90 ml/min
• Documented evidence of symptomatic MM, either newly diagnosed or relapsed/refractory
• Prior Lenalidomide exposure is permitted only if the subject did not discontinue Lenalidomide due to a Grade ≥3 related Adverse Event (AE)

You may not qualify if…

• Monoclonal Gammopathy of Undetermined Significance (MGUS), Waldenstrom's macroglobulinemia, or smoldering myeloma
• Active plasma cell leukemia
• All adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved
• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Acute renal failure

Where it is running

• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Investigative Clinical Research Of Indiana, Llc — Indianapolis, Indiana, United States
• University Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States
• University Of Maryland — Baltimore, Maryland, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Tennessee Oncology, Pllc — Nashville, Tennessee, United States
• The University Of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Va Puget Sound Health Care System — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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