A Study of two investigational drugs including PVX-410 (a Multi-Peptide Cancer Vaccine), and Citarinostat (a Histone Deacetylase Inhibitor (HDAC)) +/- Lenalidomide for Patients with Moderate or High Risk of Progression Smoldering Multiple Myeloma
Verified

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)

View More

You may be able to join this trial if you:

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. Create your account or call us today for help (888) 828-2206.

You may be eligible to participate in this study if you:

  • Are at least 18 years old.
  • Have smoldering multiple myeloma
  • Are at higher than average risk of progression to active multiple myeloma (classified as having more than 2 risk factors)
  • Has a life expectancy of greater than 6 months
  • Are HLA-A2+ (HLA testing is a way to determine your tissue type. Every patient has a tissue type. You need to be A2+ to participate in this study)
  • Cannot have received previous treatment with a HDAC inhibitor, including Citarinostat
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Not Yet Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

New York

Weill Cornell Medicine

New York, NY

Not Yet Accepting

North Carolina

Duke Cancer Center Duke University Medical Center

Durham, NC

Open and Accepting

Ohio

University Hospitals Seidman Cancer Center at UH Case Medical

Cleveland, OH

Open and Accepting

Trial Links

Read the latest news and updates on this trial.

What Are Vaccines and How Do They Work in Myeloma?

January 28, 2019

Today there are two types of cancer vaccines available: preventive and treatment. Treatment vaccines treat an existing cancer by strengthening the body’s natural immune response to the cancer. Preventative vaccines help prevent the disease from occurring in the first place, for example the HPV vaccine for cervical cancer.

Read more
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message

SparkCures Verified

SparkCures is working closely with Massachusetts General Hospital to provide the most up-to-date information on this clinical trial. Use the button above to add this trial to your list of favorites.

Learn more about how we work with trial sponsors