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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01393964
First received: July 12, 2011
Last updated: March 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
 Drug: Lenalidomide
Drug: Dexamethasone
Biological: Elotuzumab (BMS-901608; HuLuc63)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Maximum plasma concentration (Cmax) of Elotuzumab [ Time Frame: Within the first 28 days after the first dose on Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    [AUC(INF)] of Elotuzumab estimated by summing AUC(0-T) and the extrapolated area, computed by the quotient of the last quantifiable concentration and the terminal rate constant (Lz)

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    ECOG PS - Eastern Cooperative Oncology Group performance status

  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: January 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Lenalidomide + Dexamethasone +Elotuzumab
Severe Renal Impairment
 Drug: Lenalidomide
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
Other Name: Revlimid®
Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Biological: 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: Arm 2: Lenalidomide + Dexamethasone +Elotuzumab
End-stage renal disease
 Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Biological: 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
Drug: Lenalidomide
Capsules, Oral, 5 mg. Once daily on Days 1-21. Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Name: Revlimid®
Experimental: Arm 3: Lenalidomide + Dexamethasone +Elotuzumab
Normal renal function
 Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Drug: Dexamethasone
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
Other Names:
  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak® Taperpak®
Biological: 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
Drug: Lenalidomide
Capsules, Oral, 25 mg. Once daily on Days 1-21. Repeat every 28 days until subject meets criteria for discontinuation of study drug
Other Name: Revlimid®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393964

Locations
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
University Of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Tennessee
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Texas
The University Of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Va Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01393964     History of Changes
Other Study ID Numbers: CA204-007
Study First Received: July 12, 2011
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Failure, Chronic
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on May 22, 2013