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.
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
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There are 11 Locations for this study
Atlanta Georgia, 30322, United States
Indianapolis Indiana, 46260, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
New York New York, 10021, United States
New York New York, 10029, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Seattle Washington, 98108, United States
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