Multiple Myeloma
Conditions
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 Japanese sites where licensed physicians determine clinical need.
Interventions
DRUGElotuzumab
Specified dose on specified days
DRUGLenalidomide
Specified dose on specified days
DRUGDexamethasone
Specified dose on specified days
Sponsors
AbbVie
Bristol-Myers Squibb
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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:. 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 enrollment. ii) 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. * Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient. * Other protocol-defined Inclusion/
Countries
Japan
Outcome results
None listed