Diseases and Conditions Researched

Smoldering Myeloma

What is the purpose of this trial?

People who have smoldering multiple myeloma do not have symptoms but are at risk for progressing to active multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. People with active multiple myeloma generally require treatment. However, there are currently no approved therapies for smoldering multiple myeloma. The purpose of this study is to determine whether or not an investigational drug is effective and safe in treating people with high risk smoldering myeloma. The name of this investigational drug is elotuzumab. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Elotuzumab was observed to kill myeloma cells in laboratory studies.

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Participation Guidelines

Study HIC#:	1110009170

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 Myeloma Working 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 ]}

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Participation Guidelines

Study HIC#:	1110009170