Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed as a Phase II, multicenter trial of vaccination with Dendritic
      cell/myeloma fusions with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant
      plus lenalidomide maintenance therapy versus maintenance therapy alone or with GM-CSF
      following autologous transplant as part of upfront treatment of multiple myeloma (MM). It is
      hypothesized that the dendritic cell myeloma vaccine will result in improved response in
      patients with multiple myeloma after autologous Hematopoietic Cell Transplant (HCT).
    

Detailed description: 
      The study is a three-arm, phase II randomized, open-labeled clinical trial that randomizes
      patients to vaccination with Dendritic Cell (DC)/myeloma fusions/GM-CSF plus lenalidomide
      maintenance therapy or lenalidomide maintenance therapy with or without GM-CSF following
      autologous transplant as part of upfront treatment for patients diagnosed with multiple
      myeloma. Patients are randomized approximately 2 months post transplant and will begin
      maintenance lenalidomide between day 90 and 100. The primary objective of this randomized
      trial is to compare the proportion of patients alive and in complete response (defined as CR
      or sCR) at one year post transplant between patients receiving DC/myeloma vaccine/GM-CSF with
      lenalidomide maintenance therapy to those receiving lenalidomide maintenance therapy with or
      without GM-CSF.
    

Intervention name(s): Tumor Cell Collection; Autologous Stem Cell Transplant; Melphalan; Leukapheresis; Myeloma vaccine; GM-CSF; Lenalidomide
Intervention type(s): Procedure; Procedure; Drug; Procedure; Biological; Drug; Drug
Intervention description(s): 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).; 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.; Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m^2 at the schedule and timing according to institutional practices.; Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.; 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.; 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.; 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.
Other intervention name(s): Alkeran; Dendritic cell fusion vaccine; DC/MM fusion vaccine; Granulocyte macrophage colony-stimulating factor; Leukine; Revlimid™
Intervention MeSH terms: Lenalidomide; Melphalan; Molgramostim; Vaccines; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Lenalidomide; Maintenance Therapy; Hematologic Disorders; Vaccine; GM-CSF; Transplant; Anti-Myeloma Agents