Nivolumab for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests nivolumab, an immunotherapy drug, to determine its effectiveness for people with multiple myeloma, a type of blood cancer, who did not respond well to idecabtagene vicleucel. The goal is to see if nivolumab can improve their condition. Suitable candidates for this trial have experienced a recurrence or worsening of multiple myeloma after previous treatment and have tried idecabtagene vicleucel without optimal results. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial requires that you have not taken any anti-myeloma therapy or investigational drugs within 30 days before starting nivolumab, except for certain treatments related to ide-cel therapy. If you're on other medications, it's best to discuss with the trial team to see if they are allowed.
Is there any evidence suggesting that nivolumab is likely to be safe for humans?
Research has shown that nivolumab has been well-studied. In past studies, some patients experienced serious side effects, such as urinary tract infections, affecting about 4.9% of those taking nivolumab with chemotherapy. Fatal reactions were rare, occurring in 1.6% of patients when used with another drug called Yervoy, including lung problems like lung inflammation and interstitial lung disease.
The FDA has also approved nivolumab for other conditions, indicating some level of established safety. However, treatments can affect people differently. Clinical trial participants are closely monitored to manage and understand these risks.12345Why do researchers think this study treatment might be promising?
Nivolumab is unique because it leverages the immune system to fight multiple myeloma by targeting the PD-1 pathway, which is different from traditional treatments like chemotherapy and proteasome inhibitors. Unlike standard therapies that directly attack cancer cells, nivolumab works as an immune checkpoint inhibitor, essentially "releasing the brakes" on the immune system to enhance its ability to combat cancer cells. Researchers are excited about this treatment because it offers a novel mechanism of action that could lead to improved outcomes for patients, particularly those who have become resistant to conventional therapies.
What evidence suggests that nivolumab might be an effective treatment for multiple myeloma?
Research has shown mixed results for nivolumab in treating relapsed refractory multiple myeloma (RRMM). Some studies found that nivolumab alone didn't significantly help patients with RRMM. However, after another treatment called CAR-T, one study showed an 18% overall response rate, compared to a 4% response rate with nivolumab alone. This suggests it might work better when combined with other treatments. While not definitive, these findings indicate potential benefits in certain situations. Participants in this trial will receive nivolumab as a single treatment to further evaluate its effectiveness.16789
Who Is on the Research Team?
Barry A Paul, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
Adults with relapsed refractory multiple myeloma who've had a suboptimal response to idecabtagene vicleucel. They should be able to follow the study plan, have good performance status, and recovered from previous therapy effects. Exclusions include certain infections, other cancers within 2 years (with exceptions), recent transplants, known allergies to study drugs, active autoimmune diseases or lung issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adjuvant nivolumab every 4 weeks for 2 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are assessed for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Atrium Health Levine Cancer Institute
Collaborator
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania