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In this research study, we are studying smoldering multiple myeloma. Smoldering multiple myeloma is an early precursor to a rare blood cancer known as multiple myeloma, which affects plasma cells. This type of cancer produces certain proteins that can be measures in both blood and urine. These proteins show up before an individual begins to have any symptoms of cancer.
The multi-peptide vaccine, PVX-410, combined with Lenalidomide, an immunomodulatory drug that promotes immune responses to help slow tumor growth, has been previously studied and demonstrated an increase in immune activity. In this study, we will add lenalidomide to the combination of the vaccine and Citarinostat (CC-96241), an oral inhibitor which stops the growth of cancer, with the hope of augmenting immunity even further. Preclinical laboratory data has suggested Citarinostat is able to further augment immunity.
Participants will be randomized into one of the following study groups:
Safety and tolerability will be assessed by documentation of adverse events, including serious adverse events, vaccination injection site examinations, clinical laboratory tests, vital signs, physical examination findings, and performance status assessments.
Participants will be in this research study for approximately 15 months, which includes a follow-up visit after completing the first 12 months of treatment. Participants may choose to withdraw at any time or if the study doctor thinks this treatment is no longer beneficial.
Inclusion Criteria:
Exclusion Criteria:
Detailed eligibility reviewed when contacting the study team.