At a glance
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A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating Galinpepimut-S, GM-CSF, and 3 other interventions for Multiple Myeloma. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this trial is to assess the immune response after vaccination with a peptide vaccine called galinpepimut-S (or GPS) in a type of blood cancer called multiple myeloma. A protein called WT1 is often present in cancerous cells and GPS can train the immune system to recognize and kill the cancerous cells containing WT1. This study will also assess the safety of GPS, effect on disease, and on survival. Participants who has undergone autologous stem cell transplant (ASCT) will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). Vaccinations will start 12 to 22 days after ASCT. In the absence of disease progression and if clinically stable after the first 6 vaccinations, participants may continue to receive six more vaccinations every month. The use of post-ASCT maintenance therapy is allowed starting from 3 months after transplant.
Study Details
Timeline
Interventions
Galinpepimut-S admixed with the adjuvant Montanide following specified schedule
subcutaneous injection
adjuvant
optional post-ASCT therapy
optional post-ASCT therapy