Phase 2
Completed N=40
Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT01632150 ↗Enrolled (actual)
40
Serious AEs
57.5%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) — 62.5 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) |
62.5 | — |
| PRIMARY Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) |
55.0 | — |
| SECONDARY Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event |
65.0 | — |
| SECONDARY Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event |
57.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01632150). 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.