203
Participants
Start Date
July 31, 2016
Primary Completion Date
June 30, 2020
Study Completion Date
December 9, 2022
Tumor Cell Collection
Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).
Autologous Stem Cell Transplant
Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\^6 CD34+ cells/kg patient actual body weight per autologous transplantation.
Melphalan
Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\^2 at the schedule and timing according to institutional practices.
Leukapheresis
Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.
Myeloma vaccine
The target dose is 3 x 10\^6 fusion cells per vaccine. A minimum of 3 x 10\^6 total fusion cells will be required to proceed with vaccine administration. Patients who have \<3 x 10\^6 total fusion cells will not proceed with vaccination. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance. Vaccine will be administered by subcutaneous injection in the upper thigh.
GM-CSF
100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.
Lenalidomide
Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.
Mount Sinai Medical Center, New York
Memorial Sloan-Kettering Cancer Center, New York
Roswell Park Cancer Institute, Buffalo
University of Maryland/Greenebaum Cancer Center, Baltimore
Emory University, Atlanta
Ohio State University/Arthur G. James Cancer Hospital, Columbus
University Hospitals of Cleveland/Case Western, Cleveland
Medical College of Wisconsin, Milwaukee
University of Wisconsin Hospital & Clinics, Madison
University of Minnesota, Minneapolis
University of Texas/MD Anderson Cancer Center, Houston
University of California, San Francisco, San Francisco
Beth Israel Deaconess Medical Center/Dana Farber Cancer Institute, Boston
University of Nebraska Medical Center, Omaha
Fred Hutchinson Cancer Research Center, Seattle
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Cancer Institute (NCI)
NIH
National Marrow Donor Program
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH