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Cancer Vaccine
Salmonella-Based Cancer Vaccine for Multiple Myeloma (MAPSS Trial)
Phase 1
Waitlist Available
Led By Premal Lulla, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with bilirubin less than or equal to 2x upper limit of normal and Hgb greater than or equal to 7.0 (transfusion allowed)
Patients with a creatinine less than or equal to 2x upper limit of normal for age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
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.
Who is the study for?
This trial is for adults over 18 with multiple myeloma who've had at least two prior treatments, including possibly a stem cell transplant. They must be able to swallow medication, have decent organ function and blood counts, not be pregnant or breastfeeding, and agree to use effective birth control. Those with severe infections or on high-dose steroids can't join.Check my eligibility
What is being tested?
The study tests TXSVN, an investigational cancer vaccine derived from genetically modified Salmonella that targets Survivin in cancer cells. It aims to find the highest safe dose of TXSVN, understand side effects, and assess its potential effectiveness against multiple myeloma.See study design
What are the potential side effects?
Potential side effects are not fully known since this is the first time TXSVN is being tested in humans. However, based on similar vaccines' profiles, possible reactions may include flu-like symptoms such as fever and chills or gastrointestinal issues like nausea.
MAPSS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bilirubin levels are normal or slightly high, and my hemoglobin is at least 7.0.
Select...
My kidney function, measured by creatinine, is within twice the normal limit for my age.
Select...
I am able to live my life with varying degrees of assistance.
MAPSS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with dose limiting toxicity (DLT) by CTCAE, v5.0
Secondary outcome measures
Overall response rate according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.
MAPSS Trial Design
1Treatment groups
Experimental Treatment
Group I: CVD908ssb-TXSVNExperimental Treatment1 Intervention
3 different dosing schedules will be studied (3+3 design). At the beginning, patients will start on the lowest dose (1 of 3 different levels) of TXSVN. Once that dose schedule proves safe, the next group of patients will be started at a higher dose. This process will continue until all 3 dose levels are studied. If the side-effects are too severe, the dose will be lowered or the TXSVN administrations will be stopped. Each patient will receive 2 vaccinations at the same dose, 2 weeks apart, according to the following dosing schedules: The administration will be oral.
Dose Level 1
Day 0: 2 x 10^5 cfu
Day 14: 2 x 10^5 cfu
Dose Level 2
Day 0: 2 x 10^6 cfu
Day 14: 2 x 10^6 cfu
Dose Level 3
Day 0: 2 x 10^7 cfu
Day 14: 2 x 10^7 cfu
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,179 Total Patients Enrolled
6 Trials studying Multiple Myeloma
876 Patients Enrolled for Multiple Myeloma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,816 Total Patients Enrolled
5 Trials studying Multiple Myeloma
147 Patients Enrolled for Multiple Myeloma
The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,374 Total Patients Enrolled
5 Trials studying Multiple Myeloma
147 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: CVD908ssb-TXSVN
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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