Multiple MyelomaPhase 1MAPSSNCT03762291
Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine
A Phase 1 study testing CVD908ssb-TXSVN in people with Multiple Myeloma, run by Baylor College of Medicine at 1 site in United States.
Trial 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 (also known as the CVD908ssb strain) that has been genetically modified in the laboratory to produce a protein known as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CVD908ssb-TXSVN
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2021to 5 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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 (also known as the CVD908ssb strain) that has been genetically modified in the laboratory to produce a protein known as Survivin that stimulates an immune response in the body to the Survivin tumor antigen. 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.
Survivin belongs to the group of proteins known as tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They either are not found or are found in low levels normal cells in the human body. More than 90% of myeloma cancer cells have been shown to possess large quantities of Survivin.
Read more
TXSVN may activate the immune system which is your body's ability to fight disease, and help develop a response against cancer cells that express Survivin. Survivin has been safely targeted using immune cells, drugs or direct inhibitors in over 50 patients with cancers in published reports.
TXSVN, the modified strain of CVD908ssb has not been tested in humans to this date. TXSVN is an investigational product not approved by the U.S. Food and Drug Administration.
The purpose of this study is to find the largest safe dose of TXSVN, to learn what the side effects are, and to see whether this therapy might help participants with multiple myeloma.
Read the 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 to assist with the absorption of the vaccine. 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.
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 and 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.
- Participants will then come to the clinic every 3 months for the first year
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.
- Conditions
- Multiple Myeloma
- Being tested
- CVD908ssb-TXSVN
- Keywords
- hematologic malignancy, malignant proliferation of plasma cells, MM
- Medical subject headings
- Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVD908ssb-TXSVNBiological
Also called TXSVN
TXSVN may activate the immune system which is the participants body's ability to fight disease, and help develop a response against cancer cells that express Survivin. Survivin has been safely targeted using immune cells, drugs or direct inhibitors in over 50 patients with cancers in published reports.
Survivin belongs to the group of proteins known as tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They either are not found or are found in low levels normal cells in the human body. More than 90% of myeloma cancer cells have been shown to possess large quantities of Survivin.
| Study group | Role | What they receive |
|---|---|---|
| CVD908ssb-TXSVN | Experimental | 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 Receives: Biological: CVD908ssb-TXSVN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicity (DLT) by CTCAE, v5.0
Incidence of dose limiting toxicities (DLT) of CVD908ssb-TXSVN vaccine in patients with multiple myeloma.
Measured: 8 weeks
Secondary outcomes (1)
Overall response rate according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.
Overall response rate is defined as the proportion of subjects with best overall response of complete response (CR), stringent complete response (sCR), very good partial response (VGPR) or partial response (PR) according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start6 Aug 2021
- Primary completion22 Mar 2022
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Premal Lulla, Baylor College of Medicine
- Investigators
- Premal Lulla, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762291
- Sponsor's protocol ID
- H-42712 MAPSS
- Acronym
- MAPSS
- Status last verified
- Feb 2025
- First submitted
- 11 Sep 2018
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine
- ClinicalTrials.gov ID
- NCT03762291
- Acronym / sponsor ID
- MAPSS / H-42712 MAPSS
- Conditions
- Multiple Myeloma
- Keywords
- hematologic malignancy, malignant proliferation of plasma cells, MM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (also known as the CVD908ssb strain) that has been genetically modified in the laboratory to produce a protein known as Survivin that stimulates an immune response in the body to the Survivin tumor antigen. 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.
Survivin belongs to the group of proteins known as tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They either are not found or are found in low levels normal cells in the human body. More than 90% of myeloma cancer cells have been shown to possess large quantities of Survivin.
TXSVN may activate the immune system which is your body's ability to fight disease, and help develop a response against cancer cells that express Survivin. Survivin has been safely targeted using immune cells, drugs or direct inhibitors in over 50 patients with cancers in published reports.
TXSVN, the modified strain of CVD908ssb has not been tested in humans to this date. TXSVN is an investigational product not approved by the U.S. Food and Drug Administration.
The purpose of this study is to find the largest safe dose of TXSVN, to learn what the side effects are, and to see whether this therapy might help participants with multiple myeloma.
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 to assist with the absorption of the vaccine. 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.
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 and 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.
- Participants will then come to the clinic every 3 months for the first year
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVD908ssb-TXSVN | Experimental | Biological: CVD908ssb-TXSVN3 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVD908ssb-TXSVNAlso: TXSVNTXSVN may activate the immune system which is the participants body's ability to fight disease, and help develop a response against cancer cells that express Survivin. Survivin has been safely targeted using immune cells, drugs or direct inhibitors in over 50 patients with cancers in published reports. Survivin belongs to the group of proteins known as tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They either are not found or are found in low levels normal cells in the human body. More than 90% of myeloma cancer cells have been shown to possess large quantities of Survivin. | Biological | CVD908ssb-TXSVN |
Primary outcome
Number of patients with dose limiting toxicity (DLT) by CTCAE, v5.0
Time frame: 8 weeks
Incidence of dose limiting toxicities (DLT) of CVD908ssb-TXSVN vaccine in patients with multiple myeloma.
1 secondary outcome
Overall response rate according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Premal Lulla, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVD908ssb-TXSVN in people with Multiple Myeloma, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose limiting toxicity (DLT) by CTCAE, v5.0 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.