Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine (MAPSS)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring hematologic malignancy, malignant proliferation of plasma cells, MM
Eligibility Criteria
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.
Sites / Locations
- Houston Methodist Hospital
Arms of the Study
Arm 1
Experimental
CVD908ssb-TXSVN
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