Status:
COMPLETED
Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Multiple myeloma patients will receive a cancer vaccine, called TXSVN that has been derived from the bacteria Salmonella. TXSVN is a weakened form of a live vaccine strain of the Salmonella bacteria (...
Detailed Description
The vaccine will be administered orally (by mouth) as a solution mixed with sodium bicarbonate. Approximately 10 minutes prior to receiving the vaccine, participants will take sodium bicarbonate pills...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Any patient, greater than or equal to 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least two lines of conventional therapy which can include an autologous HSCT. If a patient has received an autologous or syngeneic SCT they must be greater than 90 days post-transplant
- Patients with life expectancy greater than or equal to 6 weeks.
- Pulse oximetry of greater than 90% on room air in patients who previously received radiation therapy to the chest. This is not required in patients who have not received radiation therapy to the chest in the past.
- Patients with a Karnofsky score of greater than or equal to 50
- Patients with bilirubin less than or equal to 2x upper limit of normal and Hgb greater than or equal to 7.0 (transfusion allowed).
- AST less than or equal to 3x upper limit of normal.
- ANC greater than 1000 at the time of vaccination and an ALC greater than 500.
- Patients with a creatinine less than or equal to 2x upper limit of normal for age.
- Patients should have been off other investigational therapy for one month prior to entry in this study.
- Patients should be off anti-bacterial therapy for 14 days prior to vaccination
- Patients should have been off conventional therapy for at least 1 week prior to entry in this study except immunomodulator drugs
- Informed consent explained to, understood by and signed by patient. Patient given copy of informed consent.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
- Ability to swallow medications
- Exclusion Criteria
- Severe intercurrent infection.
- Patients receiving greater than 0.5 mg/kg/day (prednisone equivalent) of systemic corticosteroids
- Pregnant or breast feeding.
- Grade II or higher nausea, vomiting or diarrhea.
- History of allergy to prior vaccination with a Salmonella vaccine
- HIV infection
- Unable to tolerate Salmonella directed antibiotics
- Household contacts who are immunocompromised, pregnant or under 2 years of age.
Exclusion
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03762291
Start Date
August 6 2021
End Date
August 5 2024
Last Update
February 5 2025
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030