This phase 1 trial is testing how well combinations of PVX-410, Citarinostat and Lenalidomide work in treating moderate/high risk Smoldering Myeloma. It will also evaluate what doses of these combinations are the safest and work the best.
This trial is currently open and accepting patients.
This trial is non-randomized, which means you will be assigned into one of two different groups, and this will determine which study drugs you will receive.
This trial is open label, which means both you and the researchers running the study will know which group you are placed in, and what drugs you will be receiving.
For both groups, this study is organized into screening period where you will undergo lab testing and tissue typing, the treatment period, and followup.
During the first three months, both groups will receive biweekly injections of PVX-410 and Hiltonol given together, and take Citarinostat orally on days 1-21 of each 28 day cycle.
During the first three months, Group 2 will additionally receive Lenalidomide orally on days 1-21 of each 28 day cycle.
Once the initial three months have been completed, patients will receive followup doses of PVX-410 at 1, 2, 3, 6 and 9 months afterwards.
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 be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
You may be eligible to participate in this study if you:
Enrollment: 20 patients (estimated)View More
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January 28, 2019
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