An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan

Bristol-Myers Squibb K.K.0 个研究点开始时间: 2016年9月20日最近更新: 2023年10月17日

适应症

试验速览

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•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:
•a.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.
•b.Patient did not discontinue lenalidomide due to a Grade over 3 related AE.

•All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade under 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.

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