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Histone Deacetylase Inhibitor
PVX-410 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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety And Tolerability Of The PVX-410 Tumor Vaccine Regimen
Secondary outcome measures
Change In Free Light Chain (FLC)
Body Weight Changes
Change In Urinary FLC Level
+2 moreTrial 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
PVX-410
2012
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,937 Previous Clinical Trials
13,199,031 Total Patients Enrolled
35 Trials studying Multiple Myeloma
2,619 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
637 Previous Clinical Trials
129,495 Total Patients Enrolled
143 Trials studying Multiple Myeloma
41,462 Patients Enrolled for Multiple Myeloma
OncoPep, Inc.Industry Sponsor
3 Previous Clinical Trials
97 Total Patients Enrolled
1 Trials studying Multiple Myeloma
22 Patients Enrolled for Multiple Myeloma
Frequently Asked Questions
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