Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)

PHASE2CompletedINTERVENTIONAL
Enrollment

203

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

June 30, 2020

Study Completion Date

December 9, 2022

Conditions
Multiple Myeloma
Interventions
PROCEDURE

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).

PROCEDURE

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.

DRUG

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.

PROCEDURE

Leukapheresis

Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.

BIOLOGICAL

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.

DRUG

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.

DRUG

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.

Trial Locations (15)

10029

Mount Sinai Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

14263

Roswell Park Cancer Institute, Buffalo

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

30322

Emory University, Atlanta

43210

Ohio State University/Arthur G. James Cancer Hospital, Columbus

44106

University Hospitals of Cleveland/Case Western, Cleveland

53211

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Hospital & Clinics, Madison

55455

University of Minnesota, Minneapolis

77030

University of Texas/MD Anderson Cancer Center, Houston

94143

University of California, San Francisco, San Francisco

02215

Beth Israel Deaconess Medical Center/Dana Farber Cancer Institute, Boston

68198-7680

University of Nebraska Medical Center, Omaha

98109-1024

Fred Hutchinson Cancer Research Center, Seattle

All Listed Sponsors
collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Marrow Donor Program

OTHER

lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT02728102 - Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401) | Biotech Hunter | Biotech Hunter