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Histone Deacetylase Inhibitor

Cancer Vaccine Combo for Multiple Myeloma

Phase 1

Waitlist Available

Led By Noopur Raje, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trialis testing a therapy to treat Multiple Myeloma, using drugs Lenalidomide, Citarinostat and PVX-410.

Who is the study for?

This trial is for adults with Smoldering Multiple Myeloma (SMM) who have a high risk of the disease progressing. Participants must have normal organ and marrow function, no history of symptomatic MM or other malignancies in the past 3 years, no severe heart conditions, infections or autoimmune diseases. They should not be on immunosuppressive medications recently and must agree to use birth control if applicable.

What is being tested?

The study tests a cancer vaccine called PVX-410 and two drugs: Citarinostat and Lenalidomide as potential treatments for SMM. The goal is to see if these interventions can prevent SMM from becoming more aggressive. Some participants may receive all three treatments while others might get only one or two.

What are the potential side effects?

Possible side effects include immune system reactions, fatigue, gastrointestinal issues like nausea or diarrhea, blood count changes which could increase infection risk, allergic responses to the vaccine components, liver enzyme alterations indicating liver stress, and potential reproductive impacts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety And Tolerability Of The PVX-410 Tumor Vaccine Regimen

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PVX-410 + Citarinostat + LenalidomideExperimental Treatment4 Interventions

Participants will receive: * 6 biweekly doses of PVX-410 * 6 biweekly doses of Hiltonol * 3 monthly cycles of Citarinostat * 3 monthly cycles of Lenalidomide

Group II: PVX-410 + CitarinostatExperimental Treatment3 Interventions

Participants will receive: * 6 biweekly doses of PVX-410 * 6 biweekly doses of Hiltonol * 3 monthly cycles of Citarinostat

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hiltonol

2015

Completed Phase 2

~110

Lenalidomide

FDA approved