Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments elotuzumab, lenalidomide, dexamethasone
Phase phase 2
Target SLAMF7
Sponsor Bristol-Myers Squibb
Start date March 2014
End date August 2018
Trial size 76 participants
Trial identifier NCT02159365, CA204-112

Summary

To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
elotuzumab BMS-901608
lenalidomide Revlimid
dexamethasone

Primary Outcomes

Measure
Estimating the incidence of G3/4 infusion reactions by the end of Cycle 2: The number and percentage of treated patients with G3/4 infusion reactions by the end of Cycle 2
time frame: End of cycle 2 treatment (approximately 56 days)

Secondary Outcomes

Measure
Estimate the incidence of any grade and G3/4 infusion reactions on-study: the number and percentage of treated patients with G3/4 infusion reactions during the entire study period
time frame: Entire study period (up to 60 days post last dose)

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: - Eastern Cooperative Oncology Group (ECOG) performance status ≤2 - Documented evidence of active multiple myeloma: - Newly diagnosed, not candidate for transplant - Relapsed/refractory who have received up to 3 prior lines of therapy - Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled: - Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide - Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE) Exclusion Criteria: - Target Disease Exceptions - Plasma cell leukemia - Monoclonal gammopathy of undetermined significance (MGUS) - Smoldering Myeloma - Primary amyloidosis - Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome

Additional Information

Official title A Phase 2 Single Arm Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.