At a glance
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Phase II Combination Immunotherapy After ASCT for Advanced Myeloma to Study MAGE-A3 Immunizations With Hiltonol® (Poly-ICLC) Plus Transfer of Vaccine-Primed Autologous T Cells Followed by Lenalidomide Maintenance
In Brief
A Phase 2 clinical trial evaluating Prevnar- Pneumococcal Conjugate Vaccine (PCV), Activated/costimulated autologous T-cell, and 2 other interventions for Myeloma. Completed, enrolled 28 participants across 2 sites.
Detailed Summary
One purpose of this study is to find out if a new combination of immune system treatments (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection ("immunity") against the myeloma cells. A second purpose is to find out how well this combination of immune system treatments is able to control the myeloma.
Study Details
Timeline
Interventions
After study enrollment, patients will receive Prevnar- Pneumococcal Conjugate Vaccine (PCV). At Day #14, Day #42, and Day #90, Day #120 and Day #150, patients will receive a booster immunization with Prevnar- Pneumococcal Conjugate Vaccine (PCV).
For all patients, the cells will be expanded ex vivo for up to 12 days and then prepared for infusion \~day 2 post-transplant. The target number of costimulated T-cells for infusion will be \~ 5 x 10e10 T-cells total in 100-500 mL total volume.
At about day 100 post-transplant, after completion of post-transplant immunological assessments and myeloma restaging studies, patients will be eligible to receive low-dose Revlamid® (Lenalidomide) 10 mg/day for maintenance therapy (10 mg/day) until progression of myeloma or development of intolerance.
After study enrollment, patients will receive both MAGE-A3/GM-CSF \[+ coinjection of 2mg of Hiltonol®(Poly-ICLC)\]. At Day #14, Day #42, Day #90, Day #120 and Day #150 patients will receive an additional immunization with MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC).