Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Brief Summary
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Detailed Description
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Conditions
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Interventions
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Elotuzumab in combination with Lenalidomide and Dexamethasone
Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Eligibility Criteria
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Inclusion Criteria
* 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.
A. Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Countries
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Related Links
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BMS Clinical Trial Information
EAP Investigator Requests
FDA Safety Alerts and Recalls
Other Identifiers
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CA204-143
Identifier Type: -
Identifier Source: org_study_id