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)1
Study Director: Mary Horowitz, MD, Center for International Blood and Marrow Transplant Research
Description: For this multi-center, randomized phase 2 trial (ClinicalTrials.gov Identifier: NCT02728102), researchers are evaluating the efficacy and safety of a dendritic cell vaccine among patients with multiple myeloma.
This study has 3 arms: 1 experimental and 2 active comparator arms. In all 3 arms patients will undergo tumor cell collection, autologous stem cell transplantation with melphalan, and maintenance therapy with lenalidomide.
In the experimental arm, patients will receive the dendritic cell vaccine and granulocyte macrophage colony-stimulating factor (GM-CSF) alongside lenalidomide maintenance. In the first comparator arm, patients will receive GM-CSF with lenalidomide maintenance. Maintenance therapy in the second comparator arm will include lenalidomide only.
The primary outcome is complete response; secondary endpoints include disease progression, minimal residual disease assessment, treatment-related mortality, and toxicity.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02728102.
Status: This study is open and recruiting patients as of August 4, 2017.
This study is sponsored by the National Heart, Lung, and Blood Institute in collaboration with the Blood and Marrow Transplant Clinical Trials Network, the National Cancer Institute, and the National Marrow Donor Program.
- Clinicaltrials.gov. Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401). NCT02728102. https://clinicaltrials.gov/ct2/show/NCT02728102. Accessed August 4, 2017.