Elotuzumab in Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance for Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

July 13, 2017

Study Completion Date

July 13, 2017

Conditions
Multiple Myeloma
Interventions
DRUG

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)."

DRUG

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.

OTHER

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.

OTHER

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."

Trial Locations (1)

10029

Icahn School of Medicine at Mount Sinai, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Hearn Jay Cho

OTHER