relapsed or refractory multiple myeloma
Conditions
Interventions
investigational material(s)
Generic name etc : Elotuzumab
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materi
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Outcome results
None listed