Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
Status and phase
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
7 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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