What's the purpose of this trial?

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.

What's being studied?

• Citarinostat is an HDAC inhibitor, a drug that can block proteins that tell cancer cells to grow and divide, which can cause cell death.
• Hiltonol (Poly ICLC) is a medicine that helps the immune system cooperate and respond better to the vaccine, called an immunostimulant.
• Lenalidomide is an immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.
• PVX-410 is a cancer vaccine that is 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.

What will happen during the trial?

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.

• GROUP 1: PVX-410, Hiltonol, Citarinostat
• GROUP 2: PVX-410, Hiltonol, Citarinostat, and Lenalidomide

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

• 6 biweekly doses of PVX-410 - (0.8 mg/peptides) via subcutaneous injection
• 6 biweekly doses of Hiltonol - (1 mg) Intramuscular injection given at the time of PVX-410 administration (this drug is administered as an adjuvant to PVX-410 to help boost the patient’s immune response to the vaccine)
• 3 monthly cycles of Citarinostat - (180 mg) administered orally once daily on days 1-21 every 28 day cycle
• This will be followed by a dose of PVX-410 at month 1, 2, 3, 6, and 9 follow-up visits

Experimental Arm 2: PVX-410 + Citarinostat + Lenalidomide

• 6 biweekly doses of PVX-410 - (0.8 mg) via subcutaneous injection
• 6 biweekly doses of Hiltonol - (1 mg) Intramuscular injection given at the time of PVX-410 administration
• 3 monthly cycles of Citarinostat - (180 mg) administered orally once daily on days 1-21 every 28 day cycle
• 3 monthly cycles of Lenalidomide - (25 mg) administered orally once daily on days 1-21 every 28 day cycle
• This will be followed by a dose of PVX-410 at month 1, 2, 3, 6, and 9 follow-up visits

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:

• Screening:The screening period, begins after you sign the informed consent form. It includes an exam and lab tests as well as tissue typing to evaluate whether or not you qualify for the clinical trial. The screening period may last about 28 days and will end with notification of whether or not you are qualified for the clinical trial.
• Treatment:If you are accepted into the trial and choose to participate, you will be treated with the study drug. Detailed information about the duration, dosing and testing procedures during the treatment period and end of treatment visit will be explained by the study doctor.
• Follow-up:following the end of active treatment you will have an additional visit with your doctor.

Additional Trial Information

Phase 1

Enrollment: 20 patients (estimated)