Personalized Cancer Vaccine for Multiple Myeloma

Overseen By Amishi Vora

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Corticosteroids, Chemotherapy, Radiotherapy, others

Disqualifiers: Myeloma events, Plasma cell leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 24 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does not allow treatment with corticosteroids (except for low doses) or prior chemotherapy for smoldering multiple myeloma. Bisphosphonates are allowed.

What data supports the effectiveness of the treatment Vaccine Therapy for Multiple Myeloma?

Research shows that cancer vaccines, including those using dendritic cells (special immune cells), can trigger strong immune responses against multiple myeloma, potentially leading to long-term disease control. Additionally, combining vaccines with other treatments like lenalidomide has shown promise in maintaining remission in patients. ^{1 2 3 4 5}

Is the personalized cancer vaccine for multiple myeloma safe for humans?

Research on cancer vaccines for multiple myeloma, including those using dendritic cells and other immune strategies, is ongoing. While specific safety data for personalized cancer vaccines is limited, studies have explored similar vaccine approaches in multiple myeloma, suggesting they are generally safe, but more research is needed to confirm this. ^{1 2 4 6 7}

How is the personalized cancer vaccine treatment for multiple myeloma different from other treatments?

The personalized cancer vaccine for multiple myeloma is unique because it aims to generate a specific immune response against the cancer by using the patient's own immune cells, potentially leading to long-term immunity and fewer side effects compared to traditional chemotherapy. This approach involves using dendritic cells, which are powerful immune cells, to present myeloma-specific antigens and stimulate a targeted attack on the cancer cells. ^{1 2 3 5 8}

What is the purpose of this trial?

This early phase I trial studies the side effects of personalized vaccine in treating patients with smoldering multiple myeloma. Vaccines made from a person's blood and bone marrow may help the body build an effective immune response to kill cancer cells.

Research Team

Krina Patel

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with smoldering multiple myeloma at intermediate or high risk of progression. Participants must have certain levels of plasma cells, kidney function, and blood counts, and be able to consent. Excluded are those with active myeloma, prior SMM treatment, other cancers, infections like TB or hepatitis B/C, pregnant women, and people with HIV.

Inclusion Criteria

My condition is confirmed as smoldering multiple myeloma without any signs of further complications.

I am at intermediate or high risk of my condition worsening to multiple myeloma according to specific health criteria.

I have a diagnosis of smoldering multiple myeloma at an intermediate or high risk.

Exclusion Criteria

I have been diagnosed with plasma cell leukemia.

Pregnant or lactating females

I have not had systemic treatment for SMM, including the prohibited ones.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive personalized vaccine subcutaneously on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Treatment repeats every 28 days for up to 6 cycles.

24 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person)

Treatment Details

Interventions

• Vaccine Therapy

Trial Overview The study is testing a personalized vaccine made from the patient's own blood and bone marrow to see if it can stimulate the immune system to destroy cancer cells in patients with smoldering multiple myeloma. It also involves radiography of biopsy specimens and Lenalidomide therapy.

Participant Groups

Group I: Stage II (personalized vaccine, lenalidomide) Experimental Treatment 3 Interventions

Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Stage I (personalized vaccine) Experimental Treatment 2 Interventions

Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

In a study of 44 patients with multiple myeloma, the two-dose SARS-CoV-2 mRNA vaccination showed low rates of adverse reactions, similar to those seen in general vaccine trials.

A high percentage of patients (93% on therapy and 94% not on therapy) developed detectable antibodies after the second dose, indicating strong immunogenicity and providing reassurance for vaccine-hesitant patients with multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and antibody response to two-dose SARS-CoV-2 messenger RNA vaccination in patients with multiple myeloma. Greenberg, RS., Ruddy, JA., Boyarsky, BJ., et al.[2023]

Chimeric antigen receptor T cells targeting the BCMA protein show promise as a potent treatment for multiple myeloma, based on preliminary results from an ongoing phase I clinical trial in China.

The therapy was well tolerated by patients and led to complete and durable responses in those with relapsed or refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sending CAR T Cells After Multiple Myeloma. [2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Vaccination of multiple myeloma: Current strategies and future prospects. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

An Allogeneic Multiple Myeloma GM-CSF-Secreting Vaccine with Lenalidomide Induces Long-term Immunity and Durable Clinical Responses in Patients in Near Complete Remission. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dendritic cell-based immunotherapy in multiple myeloma. [2019]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[The preparation of anticancer vaccine for patients with multiple myeloma on the base of monoclonal immunoglobulin loaded dendritic cells]. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Cellular and vaccine immunotherapy for multiple myeloma. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety and antibody response to two-dose SARS-CoV-2 messenger RNA vaccination in patients with multiple myeloma. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Vaccination in Multiple Myeloma: Review of Current Literature. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Sending CAR T Cells After Multiple Myeloma. [2018]