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Protocol No. BMTCTN1401

Principal Investigator Callander, Natalie

Phase II

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title Phase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell /Myeloma Fusions

Objective The standard of care for patients with Multiple Myeloma (MM) is an autologous transplant and maintenance treatment. Maintenance treatment is chemotherapy after transplant. We're doing this study to learn if maintenance treatment works better alone or with an experimental vaccine made from your own blood cells.

Treatment You will be randomized to one of three treatment plans after you receive a standard autologous stem cell transplant. The three treatment plans are: • vaccine plus GM-CSF with lenalidomide maintenance therapy • lenalidomide maintenance therapy with GM-CSF • lenalidomide maintenance therapy alone

Description For this study, you will receive an autologous transplant (transplant). An autologous transplant uses blood-forming cells that are collected from your blood stream. After they are collected and frozen, you will get a high dose of chemotherapy. Chemotherapy before a transplant is called the "conditioning regimen". The goal of chemotherapy is to kill as many cancer cells in your body as possible. It also destroys most of the normal cells in your bone marrow. To restore your marrow, your frozen blood-forming cells are thawed and transplanted back into your blood stream. The cells find their way into the bone marrow where they start making healthy blood-forming cells. The standard of care for patients with MM is an autologous transplant and maintenance treatment. Maintenance treatment is chemotherapy after transplant. There's no cure for MM, so patients get maintenance treatment to slow the return of MM after a transplant.

Some subjects may receive a vaccine, and/or GM-CSF (also known as Leukine) with their maintenance therapy. GM-CSF helps your body make new white blood cells after transplant. The vaccine is made from dendritic cells and MM tumor cells in a laboratory. We will collect a sample of your cells through your central line (or catheter). This process is called leukapheresis. If the vaccine is made successfully, it will be frozen and stored to give to you later.

Key Eligibility
  • Must be between the ages of 18 and 70
  • Must be diagnosed with multiple myeloma , High Risk MM included
  • Must be considered transplant eligible by the treating physician at time of study entry
  • Ineligible if patient received treatment with Daratumumab or other CD38 Monoclonal Antibodies
  • Ineligible if patient has had prior autologous or allogeneic HCT
  • Ineligible if patient has disease progression at any time prior to enrollment
  • Ineligible if seropositive for HIV

Applicable Disease Sites Bone Marrow Transplant; Multiple Myeloma

Therapies Involved Cytotoxic Chemotherapy; Not Applicable

Drugs Involved CC-5013 (Lenalidomide); Lenalidomide; Revlimid (Lenalidomide); gm-csf (sargramostim); gm-csf vaccine

Status Open

Participating Institutions UW Hospital and Clinics