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



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Nephrology / Urology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2012
End Date:February 2016

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PH Ib 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

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


Inclusion Criteria:

- Subjects with Multiple Myeloma (MM) and renal function fitting one of three
categories:

1. Severe renal impairment: estimated creatinine clearance (CrCl) <30 ml/min, but
not requiring dialysis

2. End-stage renal disease: requiring hemodialysis

3. 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
We found this trial at
11
sites
Indianapolis, Indiana 46254
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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1660 South Columbian Way
Seattle, Washington 98108
(206) 762-1010
VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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Seattle, WA
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Detroit, Michigan 48201
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Detroit, MI
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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New York, New York 10021
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New York, NY
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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