Clinical trial · Interventional
Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
NCT01632150CI-TRIAL-00026994completedPhase 2Results 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 determine the safety and tolerability of elotuzumab administered in combination with thalidomide and dexamethasone in the treatment of relapsed and/or refractory multiple myeloma.
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 |
|---|---|---|---|
| Relapsed and/or Refractory Multiple Myeloma | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Biological | Cyclophosphamide | ALIAS |
| Dexamethasone | Biological | Dexamethasone | ALIAS |
| Elotuzumab | Biological | Elotuzumab | ALIAS |
| Thalidomide | Biological | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide
- interventionNames
- Biological: Elotuzumab
- Biological: Thalidomide
- Biological: Dexamethasone
- Biological: Cyclophosphamide
Primary outcomes (2)
- measure
- Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
- timeFrame
- From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
- 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 unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Key Inclusion Criteria: * Confirmed diagnosis of previously treated multiple myeloma with progression documented by criteria of the International Myeloma Working Group after or during the most recent therapy * Patient received 5 or fewer prior lines of therapy * Eastern Cooperative Oncology Group performance status of 0 or 1 (safety lead-in cohort) or 0 to 2 (additional patients) * Measurable disease as defined by at least 1 of the following: * Serum immunoglobulin (Ig)G, IgA, IgM, or monoclonal (M) protein level ≥0.5 g/dL or serum IgD M protein level ≥0.05 g/dL; or * Urine M protein level ≥200 mg excreted in a 24-hour collection sample; or * Involved serum free light chain level ≥10 mg/dL, provided the free light chain ratio is abnormal Key Exclusion Criteria: * Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia * Monoclonal gammopathy of undetermined significance, smoldering myeloma, or Waldenström's macroglobulinemia * Left ventricular ejection fraction by echocardiogram or Multi Gated Acquisition ≤50% * Electrocardiogram finding of QTc ≥450 msec * Active plasma cell leukemia (defined as either 20% of peripheral white blood cells, composed of plasma/CD138+ cells or an absolute plasma cell count of 2\*10\^9/L) * Diagnosis of nonsecretory myeloma * Active hepatitis A, B, or C virus infection * Grade ≥2 neuropathy
References
Publications (0)
Data not yet available
No reference posted for this study.