Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine

Summary

Participation Requirements

Description

The vaccine will be administered orally (by mouth) as a solution mixed with sodium bicarbonate. Participants may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the...

The vaccine will be administered orally (by mouth) as a solution mixed with sodium bicarbonate. Participants may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the vaccine. Participants will remain in the clinic for three hours after receiving the vaccine for monitoring.Two doses of TXSVN will be given two weeks apart. Participants disease will be assessed pre-treatment and then 6 weeks after the second treatment. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital. In between the first and second treatments, and for 6 weeks after the last treatment, the investigators ask that participants not receive any other anti-cancer treatments such as radiation therapy or chemotherapy. If participants do receive any other therapies in-between the first and second treatment, then they will be taken off treatment and will not be able to receive the second treatment of cells. This is a dose escalation study. This means that at the beginning, patients will be started 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. Before being treated, participants will receive a series of standard medical tests: Physical exam. Blood tests to measure blood cells, kidney and liver function. Measurement of participants multiple myeloma by blood tests and bone marrow biopsy (when available). Measurements of participants tumor by routine imaging studies. The investigators will use the imaging study that was used before to follow the participants tumor: Computerized Tomography (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT), skeletal bone survey. These studies will be done on a case-by-case basis at the discretion of the participants treating physician. Pregnancy test (using a blood sample) if the participants is a female who can have children. Blood and stool cultures to ensure no ongoing infection at the time of vaccine administration. Participants will receive standard medical tests when they are getting the vaccine and after: Blood tests to measure blood cells, kidney and liver function. Blood and stool cultures at 4 days after getting the vaccine an d at least weekly for up to 8 weeks after treatment, to monitor shedding of the administered live vaccine. Measurement of the participants multiple myeloma by blood tests and/or bone marrow biopsy (when available). Imaging study (as decided by the participants treating physician) 8 weeks after the 1st vaccination. To learn more about the way the vaccine is working in the participants body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each vaccination, and weekly for eight (8) weeks after the participants first vaccination. Study Duration: The participants active participation in this study will last for approximately one (1) year. The investigators will then contact the participants once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate the participants disease response long-term. While participants are being followed on study, investigators will collect information about the response to the vaccine (how well or not the participants multiple myeloma responds to the treatment) and any toxicities the participants may experience. This study will continue until it has completed enrolling subjects and all subjects have completed follow-up or have come off study.

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