What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, including immunotherapies and vaccine-based treatments like TXSVN, often have side effects such as fatigue, infections (e.g., pneumonia, sepsis), gastrointestinal issues (e.g., diarrhea, constipation), and hematologic toxicities (e.g., thrombocytopenia, neutropenia, anemia). Specific to immunotherapies, patients may experience infusion reactions, immune-related adverse events, and potential exacerbation of autoimmune conditions. Proteasome inhibitors and immunomodulatory drugs can also cause peripheral neuropathy, cytopenias, and increased risk of secondary cancers.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of Multiple Myeloma, including monoclonal antibodies like daratumumab and elotuzumab, which target specific proteins on myeloma cells to stimulate the immune system. Additionally, chimeric antigen receptor (CAR) T-cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel have been approved, which involve modifying a patient's T cells to better attack myeloma cells. While specific cancer vaccines like TXSVN targeting Survivin-expressing cells are still under investigation, these approved therapies highlight the growing role of immunotherapy in managing Multiple Myeloma.

What other types of research exist?

Promising novel alternatives to TXSVN for Multiple Myeloma patients include: 1) Daratumumab-based regimens, which have shown higher overall response rates and improved progression-free survival in clinical trials. 2) Elotuzumab, which, when combined with lenalidomide and dexamethasone, has demonstrated efficacy in both pretreated and untreated patients. 3) Isatuximab, another anti-CD38 monoclonal antibody, which has shown positive results in combination with pomalidomide and dexamethasone for relapsed/refractory Multiple Myeloma. These therapies have demonstrated significant clinical benefits and are viable alternatives for treatment in 2024.

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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

Must not have

HIV infection

Grade II or higher nausea, vomiting or diarrhea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new cancer vaccine called TXSVN, made from a weakened Salmonella bacteria, in patients with multiple myeloma. The vaccine aims to boost the immune system to fight cancer cells by targeting a specific protein found in these cells. The study will determine the safest dose and monitor side effects and effectiveness.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bilirubin levels are normal or slightly high, and my hemoglobin is at least 7.0.

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My kidney function, measured by creatinine, is within twice the normal limit for my age.

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I am able to live my life with varying degrees of assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive.

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I experience moderate to severe nausea, vomiting, or diarrhea.

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I cannot tolerate antibiotics for Salmonella.

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I am currently suffering from a severe infection.

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I am taking more than 0.5 mg/kg/day of steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with dose limiting toxicity (DLT) by CTCAE, v5.0

Secondary study objectives

Overall response rate according to the modified International Myeloma Working Group (IMWG) Uniform Response criteria.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Myeloma include immunotherapies, proteasome inhibitors, and monoclonal antibodies. Immunotherapies, such as the TXSVN cancer vaccine, work by stimulating the immune system to recognize and attack cancer cells expressing specific antigens like Survivin. This is crucial for Multiple Myeloma patients as it offers a targeted approach to eliminate cancer cells while sparing normal cells, potentially reducing side effects. Proteasome inhibitors disrupt protein degradation in cancer cells, leading to cell death, while monoclonal antibodies target specific proteins on cancer cells to mark them for immune destruction. These mechanisms are vital as they provide multiple avenues to combat the disease, improving patient outcomes and offering hope for long-term remission.

A pilot study of pembrolizumab in smoldering myeloma: report of the clinical, immune, and genomic analysis.Current vaccination strategies for the treatment of B-cell lymphoma and multiple myeloma.