Cancer Vaccine Combo for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen ByNoopur Raje, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?This research study is studying a targeted therapy as a possible treatment for Smoldering Multiple Myeloma. The following intervention will be involved in this study: * Lenalidomide * Citarinostat (CC-96241) * PVX-410

Eligibility Criteria

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.

Inclusion Criteria

I am HLA-A2 positive.

Patient is willing and able to comply with the protocol for the duration of the study

Patient meets the CRAB criteria within 4 weeks before baseline

+10 more

Exclusion Criteria

I have been previously diagnosed with tuberculosis.

I currently have an active infection or tested positive for certain viruses.

I have used immunosuppressive medication within the last 28 days.

+10 more

Participant Groups

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.

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