Multiple Myeloma Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT01393964

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 11 Locations for this study

See Locations Near You

Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis Indiana, 46260, United States
University Of Iowa Hospitals And Clinics
Iowa City Iowa, 52242, United States
University Of Maryland
Baltimore Maryland, 21201, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Washington University School Of Medicine
Saint Louis Missouri, 63110, United States
Weill Cornell Medical College
New York New York, 10021, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Tennessee Oncology, Pllc
Nashville Tennessee, 37203, United States
The University Of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
Va Puget Sound Health Care System
Seattle Washington, 98108, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT01393964

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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