Overview

This trial is active, not recruiting.

Condition smoldering multiple myeloma
Treatment elotuzumab (bms-901608; huluc63)
Phase phase 2
Sponsor Bristol-Myers Squibb
Collaborator AbbVie
Start date December 2011
End date May 2014
Trial size 40 participants
Trial identifier NCT01441973, CA204-011

Summary

The purpose of this study is to determine if patients with high risk smoldering myeloma who have more CD56dim cells (a marker for the health of the body's immune system) will have better responses to Elotuzumab

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Elotuzumab 20 mg/kg Solution, Intravenous (IV), Cycle 1: Day 1 & Day 8; Cycle 2 and beyond: once monthly, Repeat every 28 days until subject meets criteria for discontinuation of study drug
elotuzumab (bms-901608; huluc63)
(Experimental)
Elotuzumab 10 mg/kg Solution, Intravenous (IV), Cycle 1 and 2: Weekly (On Days 1, 8, 15, and 22); Cycle 3 and beyond: Every 2 weeks (Days 1 and 15), Repeat every 28 days until subject meets criteria for discontinuation of study drug
elotuzumab (bms-901608; huluc63)

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
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
Electrocardiogram (ECG) Endpoint: The change from baseline in corrected QC Interval (QTc)
time frame: Baseline and Day 1 on Cycle 1
Electrocardiogram (ECG) Endpoint: The change from baseline in corrected QC Interval (QTc)
time frame: Baseline and Day 1 on Cycle 3
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

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Subjects with a confirmed diagnosis of smoldering multiple myeloma according to IMWG and that is considered high risk according to the following: - Serum 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% bone marrow plasma cells and serum free light chain (FLC) ratio ≤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)

Additional Information

Official title 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
Description Intervention model: The actual design is sequential (the first 15 patients are in once monthly dosing, followed by the second cohort of 15 with twice monthly dosing)
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.