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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Lenalidomide (Drug); Dexamethasone (Drug); Dexamethasone (Drug); Dexamethasone (Drug); Elotuzumab (BMS-901608; HuLuc63) (Biological); Lenalidomide (Drug); Lenalidomide (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum plasma concentration (Cmax) of Elotuzumab

The area under the Elotuzumab concentration-time curve from time zero to the last quantifiable plasma concentration, calculated by log and linear-trapezoidal summations [AUC(0-T)] of Elotuzumab

The area under the Elotuzumab concentration-time curve from zero to infinity [AUC(INF)] of Elotuzumab

Terminal-phase elimination half-life in serum (T-Half) calculated by least squares regression analysis of Elotuzumab

The time corresponding to the maximum concentration Cmax (Tmax) of Elotuzumab

Total body clearance (CLT), calculated as Dose/AUC(INF) of Elotuzumab

Apparent volume of distribution (Vz), calculated as Dose/(AUC(INF)*Lz) of Elotuzumab

The trough serum concentration immediately before the next dose (Cmin) of Elotuzumab

Secondary outcome:

Serious and non-serious adverse events, clinical laboratory tests (hematology, chemistry, urinalysis, coagulation panel), vital sign measurements, and physical examination with assessment of ECOG PS

Presence of anti-elotuzumab antibodies and serum titer values for subjects who test positive for anti-elotuzumab antibodies

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Mount Sinai Medical Center, New York, New York 10029, United States

Weill Cornell Medical College, New York, New York 10021, 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

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: December 2011
Last updated: July 3, 2015

Page last updated: August 23, 2015

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