Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments lenalidomide, dexamethasone, elotuzumab (bms-901608; huluc63)
Phase phase 1
Sponsor Bristol-Myers Squibb
Collaborator AbbVie
Start date December 2011
End date March 2014
Trial size 26 participants
Trial identifier NCT01393964, CA204-007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Severe Renal Impairment
lenalidomide Revlimid®
Capsules, Oral, 15 mg, One capsule every 48 hours through Days 1-21 (Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets, Oral, 40 mg, weekly, on days 8, 15 & 22 (cycle 1); days 8 &22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
elotuzumab (bms-901608; huluc63)
Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
(Experimental)
End-stage renal disease
dexamethasone Decadron®
Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets, Oral, 40 mg, weekly, on days 8, 15 & 22 (cycle 1); days 8 &22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
elotuzumab (bms-901608; huluc63)
Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
lenalidomide Revlimid®
Capsules, Oral, 5 mg. Once daily on Days 1-21. Repeat every 28 days until subject meets criteria for discontinuation of study drug
(Experimental)
Normal renal function
dexamethasone Decadron®
Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets, Oral, 40 mg, weekly, on days 8, 15 & 22 (cycle 1); days 8 &22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
elotuzumab (bms-901608; huluc63)
Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
lenalidomide Revlimid®
Capsules, Oral, 25 mg. Once daily on Days 1-21. Repeat every 28 days until subject meets criteria for discontinuation of study drug

Primary Outcomes

Measure
Maximum plasma concentration (Cmax) of Elotuzumab
time frame: Within the first 28 days after the first dose on Day 1 of Cycle 1
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
time frame: Within the first 28 days after the first dose on Day 1 of Cycle 1
The area under the Elotuzumab concentration-time curve from zero to infinity [AUC(INF)] of Elotuzumab
time frame: Within the first 28 days after the first dose on Day 1 of Cycle 1
Terminal-phase elimination half-life in serum (T-Half) calculated by least squares regression analysis of Elotuzumab
time frame: Within the first 28 days after the first dose on Day 1 of Cycle 1
The time corresponding to the maximum concentration Cmax (Tmax) of Elotuzumab
time frame: Within the first 28 days after the first dose on Day 1 of Cycle 1
Total body clearance (CLT), calculated as Dose/AUC(INF) of Elotuzumab
time frame: Within the first 28 days after the first dose on Day 1 of Cycle 1
Apparent volume of distribution (Vz), calculated as Dose/(AUC(INF)*Lz) of Elotuzumab
time frame: Within the first 28 days after the first dose on Day 1 of Cycle 1
The trough serum concentration immediately before the next dose (Cmin) of Elotuzumab
time frame: Immediately before the next dose of study drug at each cycle (Cycle 2 onwards)

Secondary Outcomes

Measure
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
time frame: first dose until 60 days after last dose of study drug administered
Presence of anti-elotuzumab antibodies and serum titer values for subjects who test positive for anti-elotuzumab antibodies
time frame: first dose until 60 days after last dose of study drug administered

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.