Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Relapsed and/or Refractory Multiple Myeloma

Treatments: Biological: Thalidomide; Biological: Dexamethasone; Biological: Elotuzumab; Biological: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01632150

2011-005121-49 (EudraCT Number)

CA204-010

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Elotuzumab + Thalidomide + Dexamethasone + Cyclophosphamide

Experimental group

Treatment:

Biological: Cyclophosphamide

Biological: Elotuzumab

Biological: Dexamethasone

Biological: Thalidomide