Early Patient Access Treatment Use Protocol CA204-220
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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 Japanese sites where licensed physicians determine clinical need.
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Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Men and women 20 years and older
Active, relapsed or refractory multiple myeloma by International Myeloma Working Group (IMWG) criteria as assessed by the treating physician and have received at least 1 prior line of multiple myeloma therapy.
Progression from a most recent line of therapy
Prior lenalidomide exposure is permitted only if they fulfill all of the following:
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 enrollment.
Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.
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
Known HIV infection or active hepatitis A, B, or C
Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.
Other protocol defined inclusion/exclusion criteria could apply