Multiple Myeloma
Conditions
Interventions
investigational material(s)
Generic name etc : BMS-901608 (Elotuzumab)
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investiga
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Subjects who is other than symptomatic multiple myeloma - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety and tolerability of Elotuzumab in combination with Lenalidomide and low dose Dexamethasone. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clinical activity based on the EBMT criteria - Plasma pharmacokinetics - Immunogenicity | — |
Outcome results
None listed