Expanded Access for Relapsed/Refractory Myeloma: Elotuzumab, Lenalidomide + Dex
The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need. Trial Overview
- Treatments: Elotuzumab, dexamethasone, lenalidomide
- Enrollment: There are no enrollment restrictions for this study.
- Who Sponsors this trial? Bristol-Myers Squibb
- Phase: Expanded Access
- Trial ID: MM-0718
Men and women 18 years and older Active, relapsed or refractory multiple myeloma by IMWG (International Myeloma Working Group) criteria as assessed by the treating physician and have received 1 to 3 prior lines of multiple myeloma therapy. No prior exposure to lenalidomide except in cases were: i) not refractory to prior lenalidomide defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrollment ii) lenalidomide was not discontinued due to a Grade ≥ 3 related AE Exclusion Criteria: Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L) All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2 Significant cardiac disease as determined by the treating physician including cardiac amyloidosis HIV infection or active hepatitis A, B, or C History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009 Inadequate recovery from prior surgery or prior myeloma therapy. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GvHD) Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient Certain abnormal physical or laboratory findings Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant Trial Locations: For information on this expanded access trial, please contact Clinical.Trials@bms.com. If there are no trial locations near you, your doctor can submit a Professional Request Form for Bristol-Myers Squibb's Named Patient Program. This allows for compassionate use of Elotuzumab outside of the Expanded Access Program and outside of any clinical trial. This trial has 24 active trial sites in the US. Find the closest site to your location by clicking on the SparkCures link here. For a complete list of clinical trials using this drug, click on the SparkCures finder here.