NCT02728102: Phase 2 - Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)

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

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 (BMT CTN 1401)

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).

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Collaborators: Blood and Marrow Transplant Clinical Trials Network

National Cancer Institute (NCI)

National Marrow Donor Program

Multiple Locations

ClinicalTrials.gov Identifier: NCT02728102

Official 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 (BMT CTN #1401)

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Procedure: Tumor Cell Collection

Procedure: Autologous Stem Cell Transplant

Drug: Melphalan

Procedure: Leukapheresis

Biological: Myeloma vaccine

Drug: GM-CSF

Drug: Lenalidomide

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653.Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials

Impact of Autologous Hematopoietic Cell Transplant (HCT) Followed By Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance in Increasing Multiple Myeloma (MM) Immunity (BMT CTN 1401)

https://www.sciencedirect.com/science/article/abs/pii/S000649712102886X

- California: University of California San Francisco

- Georgia: Emory University Atlanta

- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston

- Nebraska: University of Nebraska Medical Center Omaha

- New York: Tisch Cancer Institute Mount Sinai Hospital New York

- New York: Roswell Park Cancer Institute Buffalo

- New York: Memorial Sloan-Kettering Cancer Center New York

- Texas: The University of Texas MD Anderson Cancer Center Houston

- Washington: Fred Hutchinson Cancer Center Seattle