Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma (aMILs)
Patient Population: Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant.
Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the activated MILs and is at least 6 months post-transplant.
Disease response as determined by the Blade' criteria will be the primary endpoint of the trial at one year.
Additional study endpoints include progression free survival, parameters of T cell reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and clonogenic myeloma precursor cells.
Biological: Allogeneic Myeloma Vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: No ]
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)
- Evaluate Progression-free Survival and Overall Survival [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: Yes ]Patients will be monitored for progression/relapse on Days 60, 180, and 360, and as clinically indicated. Following one year follow-up, patients will be followed annually for the next four years.
- Anti-tumor immune response [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: No ]
- Evaluate tumor specific responses in blood and bone marrow
- Examine T cell responses to DC-pulsed myeloma cell lines
- Examine induction of novel antibody responses
- The effect of aMILs on osteoclastogenesis [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: No ]
Parameters of bone turnover that will include:
- RANKL/OPG ratio
- Serum C Telopeptide levels
- bAlkaline phosphatase and osteocalcin
- Effect of aMILs on clonogenic myeloma precursors [ Time Frame: Days 60, 180, and 360 ] [ Designated as safety issue: No ]• Examine side population of CD19 enriched PBLs throughout study.
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Activated marrow infiltrating lymphocytes
aMILs + allogeneic myeloma vaccine
Activated marrow infiltrating lymphocytesBiological: Allogeneic Myeloma Vaccine
Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045460
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|