Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Smoldering Multiple Myeloma

Treatments: Biological: Elotuzumab (BMS-901608; HuLuc63)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01441973

CA204-011

Details and patient eligibility

About

The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the health of the body's immune system)

Full description

Intervention model: Dosing is sequential

Enrollment: 41 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:

Participants with a confirmed diagnosis, according to criteria of the International Myeloma Working Group, of smoldering multiple myeloma, considered high risk according to the following:

• Serum monoclonal (M) protein ≥3 gm/dL and bone marrow plasma cells (BMPC) ≥10% or
• Serum M protein 1-3 g/dL and BMPC ≥10% and abnormal free light chain ratio of <0.125 or >8.0
• Urine M protein >200 mg/24 hours, ≥10% BMPC, and serum free light chain ratio ≤0.125 or ≥8.0

Key Exclusion Criteria:

• Active multiple myeloma
• Monoclonal gammopathy of undetermined significance
• Active plasma cell leukemia
• Positive for hepatitis B or C virus or HIV infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Elotuzumab, 20 mg/kg

Experimental group

Description:

Intravenous solution administered in 28-day cycles. Cycle 1: Days 1 and 8. Cycle 2 and beyond: Day 1 only.

Treatment:

Biological: Elotuzumab (BMS-901608; HuLuc63)

Elotuzumab, 10 mg/kg

Experimental group

Description:

Intravenous solution administered in 28-day cycles. Cycle 1 and 2: Days 1, 8, 15, and 22. Cycle 3 and beyond: Days 1 and 15.

Treatment:

Biological: Elotuzumab (BMS-901608; HuLuc63)