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Salmonella-Based Cancer Vaccine for Multiple Myeloma (MAPSS Trial)
MAPSS Trial Summary
This trial will test a cancer vaccine, called TXSVN, derived from Salmonella bacteria, in multiple myeloma patients. TXSVN is a weakened form of a live vaccine strain of the Salmonella bacteria (CVD908ssb) that has been genetically modified to produce a protein known as Survivin. CVD908ssb has been administered to over 80 healthy donors as a Salmonella vaccine in reported clinical trials. This trial intends to explore administration of this vaccine at a lower dose than what was tested in healthy individuals.
MAPSS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMAPSS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MAPSS Trial Design
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Who is running the clinical trial?
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- My bilirubin levels are normal or slightly high, and my hemoglobin is at least 7.0.My kidney function, measured by creatinine, is within twice the normal limit for my age.People in your household who are pregnant, have a weak immune system, or are under 2 years old.I am HIV positive.I experience moderate to severe nausea, vomiting, or diarrhea.You had an allergic reaction to a Salmonella vaccine before.I am able to live my life with varying degrees of assistance.I cannot tolerate antibiotics for Salmonella.Your white blood cell count is higher than 1000 at the time of vaccination and your lymphocyte count is higher than 500.Your AST blood test result is not more than 3 times the normal limit.I can swallow pills.I am not pregnant and willing to use effective birth control or I have had a hysterectomy or tubal ligation.I am over 18, have Myeloma, and have tried at least two treatments or had a stem cell transplant over 90 days ago.My oxygen level is above 90% without extra oxygen, after chest radiation.I haven't taken any antibiotics for the last 14 days.I stopped my conventional therapy at least a week ago, except for immunomodulators.I am currently suffering from a severe infection.I am taking more than 0.5 mg/kg/day of steroids.
- Group 1: CVD908ssb-TXSVN
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any available slots for participants in this research project?
"As per the details provided by clinicaltrials.gov, this trial is recruiting participants at present; it was launched on August 6th 2021 and last revised on November 2nd 2022."
Has the FDA given their sanction to CVD908ssb-TXSVN?
"Our research team at Power has calculated that CVD908ssb-TXSVN's safety rating is a 1, as this Phase 1 trial only provides limited evidence of its security and efficacy."
How many individuals are being monitored in this research endeavor?
"That is correct. Clinicaltrials.gov records reveal that this clinical investigation, which was first created on August 6th 2021, remains open to patient enrolment with 18 participants being sought from 1 location."
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