Expanded Access Treatment Protocol CA204-143
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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Men and women 18 years and older
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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
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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.
- Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE
Exclusion Criteria:
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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).
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All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2
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Significant cardiac disease as determined by the treating physician including cardiac amyloidosis
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HIV infection or active hepatitis A, B, or C
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History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009
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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)
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Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient
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Certain abnormal physical or laboratory findings
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Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | John Muir Medical Center | Concord | California | United States | 94520 |
2 | Compassionate Cancer Res Grp | Corona | California | United States | 92879 |
3 | City Of Hope National Medical Center | Duarte | California | United States | 91010-3000 |
4 | UC San Diego Moores Cancer Ctr | La Jolla | California | United States | 92093-0698 |
5 | Central Coast Med Oncology | Los Angeles | California | United States | 90095 |
6 | David Geffen School Of Medicine At Ucla | Los Angeles | California | United States | 90095 |
7 | Torrance Health Association | Redondo Beach | California | United States | 90277 |
8 | Sansum Santa Barbara Medical Foundation Clinic | Solvang | California | United States | 93463 |
9 | St. Mary's Hospital Med Ctr | Grand Junction | Colorado | United States | 81501 |
10 | Cancer Specialists Of North Florida | Jacksonville | Florida | United States | 32256 |
11 | The Emory Clinic | Atlanta | Georgia | United States | 30322 |
12 | Center For Cancer And Blood Disorders | Bethesda | Maryland | United States | 20817 |
13 | Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | United States | 02114 |
14 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02114 |
15 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
16 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
17 | Billings Clinic | Billings | Montana | United States | 59101 |
18 | Southeast Nebraska Cancer Center | Lincoln | Nebraska | United States | 68510 |
19 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
20 | North Shore Hematology/Oncology Associates, P.C. | East Setauket | New York | United States | 11733 |
21 | New York Presbyterian Hospital-Weill Cornell Med College | New York | New York | United States | 10021 |
22 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
23 | Cone Health Cancer Center | Greensboro | North Carolina | United States | 27403 |
24 | Northern Utah Associates | Ogden | Utah | United States | 84403 |
25 | Huntsman Cancer Institute At The Univ. Of Utah | Salt Lake City | Utah | United States | 84112 |
26 | Wellmont Medical Associates | Bristol | Virginia | United States | 24201 |
27 | Virginia Cancer Institute | Richmond | Virginia | United States | 23230 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- EAP Investigator Requests
- FDA Safety Alerts and Recalls
Publications
None provided.- CA204-143