Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments elotuzumab, bortezomib, dexamethasone
Phase phase 2
Targets SLAMF7, proteasome
Sponsor Bristol-Myers Squibb
Collaborator AbbVie
Start date November 2011
End date May 2014
Trial size 150 participants
Trial identifier NCT01478048, 2011-002695-16, CA204-009

Summary

The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will increase the time before myeloma worsens [progression free survival (PFS)].

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
On days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered
elotuzumab BMS-901608
Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until subject meets criteria for discontinuation of study drug
bortezomib Velcade®
Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets; Oral; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets; Oral; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug
(Active Comparator)
bortezomib Velcade®
Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
dexamethasone Decadron®
Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug

Primary Outcomes

Measure
Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause
time frame: Every 21 +/-7 days (Cycles 1-8) relative to the first dose of study medication
Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause
time frame: Every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication

Secondary Outcomes

Measure
PFS hazard ration in the subgroup of subjects with at least one FcγRIIIa V allele
time frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication.
Difference in response rates between treatment arms in the overall population
time frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication.
Estimate the difference in response rates between arms in the subgroup of subjects with at least one FcγRIIIa V allele
time frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication.

Eligibility Criteria

Male or female participants at least 18 years old.

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: - Documented progression from most recent line of therapy - Measurable disease - 1 to 3 prior lines of therapy - Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met: 1. The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity 2. The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose 3. The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI) Exclusion Criteria: - Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia - Active plasma cell leukemia - Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Additional Information

Official title A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.