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.
Drug: Elotuzumab in combination with Lenalidomide and Dexamethasone
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- 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 one prior line of multiple myeloma therapy
- Prior lenalidomide exposure is permitted only if they fulfill all of the following: - i)Were 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 enrolment. - ii) Patient did not discontinue lenalidomide 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 protein
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, 92708
UC San Diego Moores Cancer Center
La Jolla, California, 92093
David Geffen School of Medicine UCLA
Los Angeles, California, 90095
Cancer Specialists of North Florida
Jacksonville, Florida, 32258
Medical Associates of Brevard
Melbourne, Florida, 32935
Illinois Cancer Specialists
Niles, Illinois, 60714
Stormont Vail Health Care
Topeka, Kansas, 66606
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Center For Cancer and Blood Disorders
Bethesda, Maryland, 20817
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201
St. Louis Cancer Care LLP
Bridgeton, Missouri, 63044
Billings Clinic
Billings, Montana, 59101
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510
Oncology Hematology West PC
Omaha, Nebraska, 68114
Roswell Park Cancer Institute
Buffalo, New York, 14263
New York Presbyterian Hospital - Weill-Cornell
New York, New York, 10021
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
University of Tennessee Medical Center
Knoxville, Tennessee, 32258
Northern Utah Associates
Ogden, Utah, 84403
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, 84112
Virginia Cancer Institute
Richmond, Virginia, 23230
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb