Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate clinical efficacy of activated marrow infiltrating lymphocytes (aMILs) administered alone or in combination with allogeneic myeloma cell vaccine combined with GM-CSF producing bystander cell in patients undergoing an ASCT for multiple myeloma.
2.1.1 Evaluate Response Rates utilizing the Blade' criteria Complete Response (CR) rate Near Complete Response (nCR) rate Very Good Partial Response (VGPR) rate Partial Response (PR) rate Minimal Response (MR) rate Overall response rate (CR, VGPR, PR)
Days 60, 180, and 360
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|