A Phase I study of a vaccine called PVX-410 for patients with moderate/high risk Smoldering Multiple Myeloma is open. PVX-410 is a multi-peptide vaccine that helps promote the immune system to fight myeloma. The FDA (U.S. Food and Drug Administration) has not yet approved PVX-410 as a treatment for any disease.
The study will be testing the appropriate dosing regimen as well as the clinical and immune response to the study drugs involved. There will be two groups in this study, one receiving thePVX-410 vaccine, Hiltonol (an immunostimulant) and Citarinostat, and the other receiving the same combination plus Lenalidomide. Citaronistat is an HDAC inhibitor in the same family as panobinostat.
PVX-410 will be administered via a biweekly subcutaneous injection (a shot in the stomach) along with the biweekly Hiltonol injection (a shot into muscle). The Citarinostat and Lenalidomide will be administered orally during days 1-21 of each 28 day cycle. Participants will be monitored for two years after the initial three 28 day cycle treatment regimens have been completed.
This study invites 20 participants with moderate/high risk smoldering myeloma with HLA-A2+ tissue type. Patients may not have had previous exposure to an HDAC inhibitor, including Citarinostat. Patients must also have adequate cardiac, hepatic, renal and bone marrow function.
To learn more about this study, including full inclusion/exclusion criteria, you can call SparkCures at (888) 828-2206, or click the button below.