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Bristol-Myers Squibb

Expanded Access Treatment Protocol CA204-143

Official Title: 
An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Brief Summary: 
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.
Approved for marketing
Multiple Myeloma

Drug: Elotuzumab in combination with Lenalidomide and Dexamethasone

Eligibility Criteria: 

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

Eligibility Gender: 
All
Eligibility Age: 
Minimum: 18 Years
Countries: 
Puerto Rico, United States
Locations: 

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

Bristol-Myers Squibb
EA Number: 
MeSH Terms: 
Multiple Myeloma, Neoplasms, Plasma Cell, Dexamethasone, Dexamethasone acetate, Lenalidomide, Elotuzumab, BB 1101
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