Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
This trial is active, not recruiting.
|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|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
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
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
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
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
|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|
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