This trial is active, not recruiting.

Condition multiple myeloma
Treatment bms-901608 (elotuzumab)
Phase phase 1
Sponsor Bristol-Myers Squibb
Start date January 2011
End date February 2014
Trial size 6 participants
Trial identifier NCT01241292, CA204-005


The purpose of this study is to assess the safety and tolerability of Elotuzumab when given in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or refractory multiple myeloma (MM) in Japan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
bms-901608 (elotuzumab)
Injection, Intravenous, 10 or 20 mg/kg, Weekly at cycle 1 and 2, bi-weekly at cycle 3 and thereafter, Until disease progression or unacceptable toxicity became apparent

Primary Outcomes

Assessment of safety and tolerability of Elotuzumab in combination with Lenalidomide and low dose Dexamethasone, based on the assessment of the Dose Limiting Toxicity (DLT) expression
time frame: Within the first 28 days

Secondary Outcomes

Clinical activity based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria
time frame: Day 1 of each cycle from cycle 2
Plasma pharmacokinetics
time frame: Day 1, 8, 15 and 22 of cycle 1, Day 1 and 22 of cycle 2, Day 1 and 15 of cycle 3, Day 1 of cycle 4 and 6 and every 3 cycles thereafter
time frame: Day 1 of cycle 1, 2, 3, 4, 6 and every 3 cycles thereafter

Eligibility Criteria

Male or female participants at least 20 years old.

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: - Received between 1 to 4 prior lines of therapy - Measureable disease - Men and women of childbearing potential (WOCBP) must be using two acceptable methods of contraception - Men must agree to use a latex condom and a second form of birth control during sexual contact with WOCBP and must agree to not donate semen during study drug therapy - Subjects must be willing to refrain from blood donations during study drug therapy Exclusion Criteria: - Subjects with non-secretory or oligo-secretory or light-chain only myeloma or active/prior plasma cell leukemia or known /suspect POEMS syndrome - Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia - Unable to take aspirin daily as prophylactic anticoagulation therapy. Prior history of inability to tolerate weekly 40 mg dexamethasone - History of renal failure - History of clinical significant thrombosis, such as treatment for thrombosis was required

Additional Information

Official title Phase 1 Multiple Ascending Dose Study of Elotuzumab (BMS-901608) in Combination With Lenalidomide/Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.