Status:
COMPLETED
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Multiple Myeloma
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
January 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01241292
Start Date
January 14 2011
End Date
January 16 2017
Last Update
February 15 2018
Active Locations (3)
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1
Local Institution
Nagoya, Aichi-ken, Japan, 4600001
2
Local Institution
Nagoya, Aichi-ken, Japan, 4678602
3
Local Institution
Niigata, Niigata, Japan, 9518566