Overview

This trial is active, not recruiting.

Condition relapsed and/or refractory multiple myeloma
Treatments elotuzumab, thalidomide, dexamethasone, cyclophosphamide
Phase phase 2
Target SLAMF7
Sponsor Bristol-Myers Squibb
Collaborator AbbVie
Start date May 2012
End date October 2013
Trial size 40 participants
Trial identifier NCT01632150, 2011-005121-49, CA204-010

Summary

The purpose of this study is to determine how safe and well tolerated Elotuzumab is in combination with Thalidomide and Dexamethasone when treating patients with relapsed and/or refractory Multiple Myeloma (MM).

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 BMS-901608
Solution, Intravenous (IV), 10 mg/kg, Cycle 1 & 2 - weekly. Every 2 weeks thereafter, Until progression/ treatment discontinuation
thalidomide Thalomid®
Capsules, By mouth (PO), 50 mg, Cycle 1 - Daily days 1-14, Until progression/ treatment discontinuation
thalidomide Thalomid®
Capsules, PO, 100 mg, Cycle 1 - Daily days 15-28, Until progression/ treatment discontinuation
thalidomide Thalomid®
Capsules, PO, 200 mg, Cycle 2 onwards - Daily, Until progression/ treatment discontinuation
dexamethasone Decadron®
Tablets, PO, 28 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 &15 (cycles 3 and beyond), Until progression/ treatment discontinuation
dexamethasone Decadron®
Tablets, PO, 40 mg , Once daily, on Days 8 & 22 (cycles 3 and beyond), Until progression/ treatment discontinuation
dexamethasone Decadron®
Solution, IV, 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 &15 (cycles 3 and beyond), Until progression/ treatment discontinuation
cyclophosphamide Cytoxan
Tablets, PO, 50, Daily starting C3 (if applicable, for subjects not achieving Partial Response (PR) by end of Cycle 4), Until progression/ treatment discontinuation

Primary Outcomes

Measure
Proportion of subjects who experience one or more severe (Grade 3 or higher) non-hematologic adverse events
time frame: Up to 60 days after the last dose

Secondary Outcomes

Measure
Proportion of subjects who experience one or more dose reductions or discontinuation of study treatment due to drug related adverse events
time frame: Up to 60 days after the 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: - Confirmed diagnosis of previously treated multiple myeloma with documented progression International Myeloma Working Group (IMWG) criteria after or during the most recent therapy - Patient received 5 or less prior lines of therapy - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (safety lead-in cohort) or 0-2 (additional subjects) - Measurable disease as defined by at least one of the following; 1. Serum immunoglobulin G (IgG), IgA, IgM M-protein ≥0.5 g/dL, or serum IgD M-protein ≥0.05 g/dL; OR 2. Urine M protein ≥200 mg excreted in a 24-hour collection sample; OR 3. Involved serum free light chain level ≥10 mg/dL provided the free light chain ratio is abnormal Exclusion Criteria: - Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia - Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma or Waldenström's macroglobulinemia - LVEF by echocardiogram or Multi Gated Acquisition (MUGA) must not be ≤50% - Electrocardiogram (ECG) QTc ≥450 msec will be excluded - Active plasma cell leukemia (defined as either 20% of peripheral White Blood Cells (WBC) comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L to 2 x 100,000,0000/L) - Subjects with non-secretory myeloma - Active hepatitis A, B, or C - Grade ≥2 neuropathy

Additional Information

Official title Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or 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.