Cancer Vaccine + Lenalidomide for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, SVN53-67/M57-KLH Peptide Vaccine, combined with lenalidomide to treat multiple myeloma, a type of blood cancer. The goal is to determine if the vaccine enhances the immune system's ability to fight cancer when paired with lenalidomide. Participants will either receive the vaccine and lenalidomide together from the start or the vaccine first, followed by lenalidomide. Ideal participants are those recently diagnosed with multiple myeloma who have responded positively to initial treatment. As a Phase 1 trial, this research aims to understand how this new treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the SVN53-67/M57-KLH peptide vaccine, combined with sargramostim, is undergoing testing to determine its safety for treating patients with multiple myeloma. As this vaccine is in the early testing stages, researchers focus primarily on patient tolerance and potential side effects.
Lenalidomide, another component of the treatment, has already received approval for certain cancer treatments. It can cause side effects such as tiredness and low blood cell counts, but most patients tolerate it well.
In summary, while the safety of the SVN53-67/M57-KLH vaccine remains under study, lenalidomide is generally considered safe. Researchers are carefully examining this combination to ensure patient safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment for multiple myeloma because it combines a cancer vaccine with lenalidomide, offering a novel approach to managing the disease. Unlike current standard treatments, which typically include chemotherapy, stem cell transplants, and existing immunomodulatory drugs, this approach uses the SVN53-67/M57-KLH peptide vaccine to stimulate the immune system specifically against cancer cells. The addition of sargramostim, which boosts white blood cell production, further enhances the immune response. By integrating a vaccine with lenalidomide, which is already known for its effectiveness in maintaining remission, this treatment has the potential to provide a more targeted and sustained defense against myeloma.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that the SVN53-67/M57-KLH peptide vaccine might help the immune system attack cancer cells, particularly those with the protein survivin. This could benefit the treatment of multiple myeloma, a type of blood cancer. Previous patients who received a similar vaccine demonstrated an effective immune response. In this trial, participants will receive the vaccine combined with lenalidomide maintenance therapy. Lenalidomide, a drug used to maintain treatment, has slowed the progression of multiple myeloma in many patients. Studies have found that ongoing use of lenalidomide can provide significant benefits, such as longer periods without disease progression. Together, these treatments aim to enhance the body's ability to fight cancer and prevent its growth.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SVN53-67/M57-KLH Peptide Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
Celgene
Industry Sponsor
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