This research study is a phase I clinical trial primarily evaluating the safety of an immunotherapy as a possible treatment for patients with moderate/high risk Smoldering Multiple Myeloma. The study will also be evaluating the appropriate dosing regimen as well as the clinical response and patient’s immune response to the study drugs involved.
The study will test two different combinations of the study drugs; a combination of the vaccine (PVX-410) along with Citarinostat (CC-96241) and a triple combination of the vaccine, Citarinostat, and Lenalidomide.
There are two experimental arms to this study. One arm is evaluating the combination of PVX-410 and Citarinostat. The other arm is a triplet combination evaluation of PVX-410 with Citarinostat and Lenalidomide.
This is a non-randomized study so you will know which arm you would be participating in if you are eligible for the study.
Experimental Arm 1: PVX-410 + Citarinostat
Experimental Arm 2: PVX-410 + Citarinostat + Lenalidomide
How long will I be in the study?
If you qualify and choose to participate, your total length of time in the study, including the screening, dosing period(s), and follow-up periods, will be about 16 months.
This study includes four periods:
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
You may be eligible to participate in this study if you:
The following criteria is provided for health care professionals.
The following is a listing of trial locations that are open and accepting patients.