The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.
This is a dose escalation, phase 1/2a study to assess the safety and tolerability of PVX-410, (a multi-peptide cancer vaccine), treatment regimen in patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.. Approximately 22 patients will receive six (6) bi-weekly, subcutaneous injections of PVX-410 for a total of twelve (12) weeks of treatment. Safety will be monitored throughout the study. Tolerability, immunogenicity and clinical response will also be measured as described in the protocol.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of a dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
All adverse events will be recorded.
Time frame: Throughout treatment phase (3 months) and follow up period (12 months)
Immune response to the vaccine will be measured
Patient blood samples will be measured for immune response through ELISPOT and Pentamer assays.
Time frame: Designated timepoints during the treatment phase (3 months) and follow up phase (12 months)
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Massachusetts General Hospital
Boston, Massachusetts, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States