At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Activated marrow infiltrating lymphocytes, Allogeneic Myeloma Vaccine, and 5 other interventions for Multiple Myeloma. Completed, enrolled 36 participants across 1 site.
Detailed Summary
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. Study Objectives: 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.
Study Details
Timeline
Interventions
Administered on Days 3 and 4.
Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.
Administered at 2.5 g/m\^2.
Administered post cyclophosphamide daily until leukapheresis.
Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.
100 mg/m\^2/day given on Days -2 and -1.
Infused on Day 0.