Clinical trial · Interventional
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
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
NCT01241292CI-TRIAL-00031693completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-901608 (Elotuzumab) 10 mg | Biological | — | UNRESOLVED |
| BMS-901608 (Elotuzumab) 20 mg | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BMS-901608 (Elotuzumab) 10mg
- interventionNames
- Biological: BMS-901608 (Elotuzumab) 10 mg
- type
- EXPERIMENTAL
- label
- BMS-901608 (Elotuzumab) 20mg
- interventionNames
- Biological: BMS-901608 (Elotuzumab) 20 mg
Primary outcomes (5)
- measure
- Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths
- timeFrame
- First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
- description
- AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Data cut-off February 2014.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDIida S, Nagai H, Kinoshita G, Miyoshi M, Robbins M, Pandya D, Bleickardt E, Chou T. Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study. Int J Hematol. 2017 Mar;105(3):326-334. doi: 10.1007/s12185-016-2138-4. Epub 2016 Nov 15. PMID 27848182