Cancer Vaccine + Lenalidomide for Multiple Myeloma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Must be taking: Lenalidomide

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

Disqualifiers: Pregnancy, HIV, Hepatitis, Autoimmune disorders, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 21

Duration: 16 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is evaluating whether a vaccine which targets a protein found in cancer cells may help treat multiple myeloma.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that you have not received certain treatments like chemotherapy or immunotherapy within 4 weeks of starting the study. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.

Is the Cancer Vaccine + Lenalidomide treatment for Multiple Myeloma safe for humans?

The safety data for similar cancer vaccines, like those used in prostate and cervical cancer trials, show that they are generally well tolerated with low toxicity and no serious adverse effects reported. ^{1 2 3 4 5}

How is the treatment with Cancer Vaccine + Lenalidomide for Multiple Myeloma different from other treatments?

This treatment is unique because it combines a cancer vaccine with lenalidomide, which enhances the immune system's response to the vaccine, potentially leading to better outcomes for patients with multiple myeloma. Lenalidomide helps boost the body's immune response by activating T and NK cells, making the vaccine more effective in targeting cancer cells. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment SVN53-67/M57-KLH Peptide Vaccine, SurVaxM, SVN53-67/M57-KLH Peptide Vaccine for multiple myeloma?

Research shows that lenalidomide, a component of the treatment, can boost the immune system's response to vaccines and improve the body's ability to fight multiple myeloma. Studies also indicate that lenalidomide enhances the effectiveness of other cancer vaccines, suggesting it may help the peptide vaccine work better in treating multiple myeloma. ^{6 8 9 11 12}

Who Is on the Research Team?

Jens Hillengass, MD, PhD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for newly diagnosed multiple myeloma patients who've responded to initial therapy, have specific HLA types (HLA-A*02, A*03, A*11, or A*24), and meet certain health criteria like good organ function and no serious infections. They must not be pregnant or breastfeeding and should agree to the Revlimid REMS® program's requirements.

Inclusion Criteria

Able to adhere to the study visit schedule and other protocol requirements

Your platelet count is at least 30,000 per cubic millimeter.

My multiple myeloma has partially improved after initial treatment.

Exclusion Criteria

You have known allergies to thalidomide, lenalidomide, Keyhole Limpet Hemocyanin (KLH), or granulocyte colony-macrophage stimulating factor (GM-CSF).

You are expected to live for less than 4 months.

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SVN53-67/M57-KLH peptide vaccine and sargramostim every 2 weeks for up to 4 doses, with a booster dose at week 12 or 16, and lenalidomide maintenance therapy starting at week 0 or 4

16 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Visits at 16, 20, and 24 weeks, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• SVN53-67/M57-KLH Peptide Vaccine

Trial Overview The study tests a SVN53-67/M57-KLH peptide vaccine with incomplete Freund's adjuvant plus sargramostim in patients on lenalidomide maintenance therapy. The goal is to see if this combination can stimulate an immune response that targets cancer cells expressing survivin.

How Is the Trial Designed?

Group I: Group B (vaccine and week-0 lenalidomide maintenance therapy) Experimental Treatment 5 Interventions

Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC every 2 weeks at weeks 4, 6, 8, and 10 for up to 4 doses and then receive a booster in week 16. Beginning in week 0, patients receive lenalidomide maintenance therapy PO QD in the absence of disease progression or unacceptable toxicity.

Group II: Group A (vaccine and week-4 lenalidomide maintenance therapy) Experimental Treatment 5 Interventions

Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC every 2 weeks at weeks 0, 2, 4, and 6 for up to 4 doses and then receive a booster in week 12. Beginning in week 4, patients receive lenalidomide maintenance therapy PO QD in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Celgene

Industry Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Published Research Related to This Trial

In an early phase clinical trial involving patients with relapsed multiple myeloma, lenalidomide was shown to enhance immune responses to the pneumococcal vaccine, particularly when both vaccinations were given while on lenalidomide.

Patients who responded clinically to myeloma treatment exhibited increased tumor-specific immune responses, indicating that lenalidomide may not only boost vaccine efficacy but also enhance the body's ability to fight cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide-induced immunomodulation in multiple myeloma: impact on vaccines and antitumor responses. Noonan, K., Rudraraju, L., Ferguson, A., et al.[2021]

The KRM-20 cancer vaccine, which targets 12 different tumor-associated antigens, was found to be safe in a study of 17 patients with castration-resistant prostate cancer, with no serious adverse reactions reported.

The 20 mg dose of KRM-20 showed the best immune response, leading to increased cytotoxic T lymphocyte activity and fewer immune suppressive cells, making it a promising candidate for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of a cancer vaccine consisting of 20 mixed peptides in patients with castration-resistant prostate cancer: dose-related immune boosting and suppression. Noguchi, M., Arai, G., Matsumoto, K., et al.[2015]

The study involved 21 patients with high-grade serous ovarian cancer treated with a vaccine and bevacizumab, showing that the treatment was generally well tolerated, with only one case of severe toxicity and a small percentage experiencing significant side effects.

While the vaccine induced an immunogenic response in a majority of patients, this response did not correlate with improved survival outcomes, although increased levels of IL-8 were linked to better progression-free survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of patients with recurrent ovarian cancer treated with a polyvalent vaccine with bevacizumab combination. Kahn, RM., Ragupathi, G., Zhou, QC., et al.[2023]

The combination of personalized peptide vaccination (PPV) and estramustine phosphate (EMP) was found to be safe for patients with castration-resistant prostate cancer (CRPC), with no serious treatment-related adverse events reported and only mild skin reactions observed.

The treatment successfully boosted immune responses in a significant portion of patients, with 67% showing enhanced cytotoxic T lymphocyte responses, and a median survival time of 23.8 months, suggesting promising antitumor activity that warrants further clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of personalized peptide vaccination using 14 kinds of vaccine in combination with low-dose estramustine in HLA-A24-positive patients with castration-resistant prostate cancer. Noguchi, M., Uemura, H., Naito, S., et al.[2013]

In a study of 57 patients with castration-resistant prostate cancer, personalized peptide vaccination (PPV) combined with low-dose estramustine phosphate (EMP) significantly improved progression-free survival (PFS) compared to standard-dose EMP, with a median PFS of 8.5 months versus 2.8 months.

The combination of PPV and low-dose EMP was well tolerated, showing no major adverse effects and enhancing immune responses, indicating it could be a safer and more effective treatment option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized phase II trial of personalized peptide vaccine plus low dose estramustine phosphate (EMP) versus standard dose EMP in patients with castration resistant prostate cancer. Noguchi, M., Kakuma, T., Uemura, H., et al.[2020]

Citations

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

Lenalidomide-induced immunomodulation in multiple myeloma: impact on vaccines and antitumor responses. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Changes in immune cell populations following KappaMab, lenalidomide and low-dose dexamethasone treatment in multiple myeloma. [2023]

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

Lenalidomide Augments the Antitumor Activities of Eps8 Peptide-Specific Cytotoxic T Lymphocytes against Multiple Myeloma. [2020]

4. 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]

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

Lenalidomide Synergistically Enhances the Effect of Dendritic Cell Vaccination in a Model of Murine Multiple Myeloma. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Phase I trial of a cancer vaccine consisting of 20 mixed peptides in patients with castration-resistant prostate cancer: dose-related immune boosting and suppression. [2015]

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

Phase I immunotherapeutic trial with long peptides spanning the E6 and E7 sequences of high-risk human papillomavirus 16 in end-stage cervical cancer patients shows low toxicity and robust immunogenicity. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Long-term outcomes of patients with recurrent ovarian cancer treated with a polyvalent vaccine with bevacizumab combination. [2023]

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

A phase I study of personalized peptide vaccination using 14 kinds of vaccine in combination with low-dose estramustine in HLA-A24-positive patients with castration-resistant prostate cancer. [2013]

10. Germany pubmed.ncbi.nlm.nih.gov

A randomized phase II trial of personalized peptide vaccine plus low dose estramustine phosphate (EMP) versus standard dose EMP in patients with castration resistant prostate cancer. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

Lenalidomide enhances anti-myeloma cellular immunity. [2021]

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

Revaccination after Autologous Hematopoietic Stem Cell Transplantation Is Safe and Effective in Patients with Multiple Myeloma Receiving Lenalidomide Maintenance. [2020]