Expanded Access Treatment Protocol CA204-143
Status: | Available |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Contact: | Please Contact |
Email: | Clinical.Trials@bms.com |
An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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.
combination with lenalidomide and dexamethasone for patients with relapsed or refractory
multiple myeloma at U.S. sites where licensed physicians determine clinical need.
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 physicial or laboratory findings
- Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab
formulation, or recombinant protein
We found this trial at
25
sites
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 855-644-6387
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-3863
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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2401 W Belvedere Ave
Baltimore, Maryland 21215
Baltimore, Maryland 21215
(410) 601-9000
Phone: 410-601-8461
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
Bethesda, Maryland 20817
(301) 571-0019
Phone: 301-571-0988
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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3855 Health Sciences Dr,
La Jolla, California 92093
La Jolla, California 92093
(858) 822-6100
Phone: 858-822-6196
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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10833 Le Conte Ave
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-4321
Phone: 310-794-3550
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
Phone: 801-585-0159
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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