Phase 1
Completed N=6
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
Source: ClinicalTrials.gov NCT01241292 ↗Enrolled (actual)
6
Serious AEs
83.3%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths — 2; 3; 1; 3 participants
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 myeloma (MM) in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths |
2; 3; 1; 3; 0; 1 | — |
| PRIMARY Number of Participants With Clinically Relevant Vital Sign Findings |
0; 0 | — |
| PRIMARY Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests |
3; 3; 0; 1; 3; 3 | — |
| PRIMARY Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests |
3; 3; 0; 0; 1; 2 | — |
| PRIMARY Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests |
0; 2; 0; 0; 3; 2 | — |
| SECONDARY Number of Participants With Best Overall Response - Treated Participants |
0; 1; 1; 2; 1; 0 | — |
| SECONDARY Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3 |
173; 376; 237; 549; 297; 652 | — |
| SECONDARY Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3 |
59.1; 165; 97.0; 252; 24.6; 280 | — |
| SECONDARY Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants |
3; 0 | — |
Eligibility Criteria
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [email protected]. 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
Data sourced from ClinicalTrials.gov (NCT01241292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.