A Phase 2 Biomarker Study of Elotuzumab (Humanized anti-CS1 Monoclonal IgG1 Antibody) Monotherapy to Assess the Association Between NK Cell Status and Efficacy in High Risk Smoldering Myeloma

Trial Purpose and Description

Trial Purpose

This is a Phase 2, open-label, multi-center trial exploring the association between baseline percent CD56dim cells in bone marrow and the maximal change in monoclonal protein in patients with high risk SMM treated with elotuzumab monotherapy.

Primary Outcome Measures:

·         The association between Elotuzumab-induced change in monoclonal protein and baseline percentage of CD56dim/CD16+/CD3-/CD45+ Natural Killer (NK) cells in bone marrow [ Time Frame: Baseline (for NK cells in bone marrow) and once every 4 weeks +/- 7 days (for monoclonal protein) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

·         Objective Response Rate: the proportion of subjects who have a partial or better response according to modified International MyelomaWorking Group (IMWG) criteria [ Time Frame: Once every 4 weeks +/- 7 days ] [ Designated as safety issue: No ]

·         Electrocardiogram (ECG) Endpoint: The change from baseline in corrected QC Interval (QTc) [ Time Frame: Baseline and Day 1 on Cycle 1 ] [ Designated as safety issue: Yes ]

·         Electrocardiogram (ECG) Endpoint: The change from baseline in corrected QC Interval (QTc) [ Time Frame: Baseline and Day 1 on Cycle 3 ] [ Designated as safety issue: Yes ]

_{2 year progression free survival: The time from first dose of Elotuzumab until documented disease progression or death [ Time Frame: Once every 4 weeks +/- 7 days until documented disease progression ] [ Designated as safety issue: No ]}

Participation Guidelines

Eligibility Criteria

Inclusion Criteria:

·         Subjects with a confirmed diagnosis of smoldering multiple myeloma according to IMWG and that is considered high risk according to the following:

o    Serum M protein ≥ 3 gm/dL and bone marrow plasma cells (BMPC) ≥ 10% or

o    Serum M protein 1 - 3 g/dL and BMPC ≥ 10% and abnormal free light chain ratio of < 0.125 or > 8.0

Exclusion Criteria:

·         Active multiple myeloma

·         Monoclonal Gammopathy of Undetermined Significance (MGUS)

·         Active plasma cell leukemia

Positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)

Dates:

March 2012

Last Updated:

Study HIC#:

1110009170

Clinicaltrials.gov ID: Yale2110210