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

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.

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