This research study is studying a targeted therapy as a possible treatment for Smoldering Multiple Myeloma. The following intervention will be involved in this study: * Lenalidomide * Citarinostat (CC-96241) * PVX-410
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. In this research study, the investigators 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. The study will test two different combinations of the study drugs; a combination of the vaccine (PVX-410) along with Citarinostat (CC-96241) and triple combination of the vaccine, Citarinostat, and Lenalidomide. The vaccine (PVX-410) is a multi-peptide vaccine that contains four synthetic peptides that together are intended to induce a T cell-mediated immune response against the myeloma. The FDA (the U.S. Food and Drug Administration) has not approved PVX-410 as a treatment for any disease. Citarinostat is an orally active, small-molecule Histone Deacetylase (HDAC) Inhibitor which is being combined here to further augment the immune activity of the vaccine. Citarinostat has not been approved by the FDA as a treatment for any disease. Lenalidomide is commercially available analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties that has demonstrated an increase in immune activity in previous trials. The FDA has approved Lenalidomide as a treatment option for Smoldering Multiple Myeloma. Lenalidomide is being added to the combination of the vaccine and Citarinostat because it is hypothesized that co-administration of lenalidomide along with Citarinostat would further enhance the T cell-mediated immune response induced by PVX-410.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
19
Intramuscular injection of Hiltonol (1 mg) administered Biweekly at the time of PVX-410 administration
Citarinostat (180 mg) administered orally once daily on days 1-21 every 28 day cycle.
Lenalidomide (25 mg) administered orally once daily on days 1-21 every 28 day cycle.
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Safety And Tolerability Of The PVX-410 Tumor Vaccine Regimen
The proportion of participants who experience dose limiting toxicities and other toxicities. The CTCAE version 4 criteria will be used to grade adverse events.
Time frame: 2 years
Immune Responses Of Lymphocytes To HLA A2+
Time frame: 2 years
Change In Monoclonal (M) Serum Protein
Time frame: 2 years
Change In Free Light Chain (FLC)
Time frame: 2 years
Change In Urinary FLC Level
Time frame: 2 years
Correlation of Immune Response and Clinical Anti-tumor Responses
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PVX-410 Biweekly (0.8 mg) via subcutaneous injection
Duke University Medical Center
Durham, North Carolina, United States
University Hospital of Cleveland- Seidman Cancer Center
Cleveland, Ohio, United States