15
Participants
Start Date
January 31, 2016
Primary Completion Date
July 13, 2017
Study Completion Date
July 13, 2017
Elotuzumab
"The following must also be administered before any elotuzumab:~Dexamethasone 8 mg IV (on the day of elotuzumab infusion 45-90 mins prior to the start of infusion), the following 30 - 90 minutes prior to start of infusion: H1 blocker: diphenhydramine (25 - 50 mg po or IV) or equivalent, H2 blocker: ranitidine (50 mg IV) or equivalent (adjusted for renal failure as indicated), acetaminophen (650 - 1000 mg po)."
Lenalidomide
On the days of elotuzumab administration, the dose of lenalidomide is to be administered at least 2 hours after completion of elotuzumab dosing. Aspirin 81 mg PO daily will also be prescribed for DVT prophylaxis.
autologous PBMC reconstitution
Autologous peripheral blood mononuclear cell collection and reconstitution. PBMC will be collected from patients by standard apheresis procedures. Up to 25 ml of autologous plasma will also be recovered for dilution of cryopreserved products (if necessary). For reconstitution, Patients will be pre-medicated as per each institution's standard protocols prior to reinfusion of PBMC products. Patient ID will be checked and verified by nursing staff and the products will be re-infused by continuous intravenous infusion pump. Patient vital signs will be monitored every 15 minutes for the duration of the procedure as per standard reinfusion protocol.
ASCT
"Autologous peripheral blood stem cell transplantation. (stem cells from the patient's own marrow are harvested, stored and then returned to the body (engrafted). To be done as part of standard of care."
Icahn School of Medicine at Mount Sinai, New York
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Hearn Jay Cho
OTHER