Teclistamab + Mezigdomide for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining the drugs teclistamab and mezigdomide offers a safe and effective treatment for individuals with multiple myeloma that has returned or is unresponsive to other treatments. Participants will initially receive mezigdomide to prepare the cancer cells for the combined treatment with teclistamab. Suitable candidates for this trial have multiple myeloma that has relapsed after at least two different therapies and exhibit symptoms such as measurable M-protein levels or new plasmacytomas (tumors composed of plasma cells). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new combination therapy.
Do I need to stop my current medications to join the trial?
The trial requires that you stop any systemic anti-myeloma therapy, including systemic steroids, at least 14 days before starting the study drug. Additionally, you should not take strong CYP3A modulators or proton-pump inhibitors within 2 weeks of starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using teclistamab and mezigdomide together might be safe and well-tolerated for treating multiple myeloma, a type of blood cancer. Studies have found that teclistamab can be a good option after other treatments, like BCMA-targeted therapies, suggesting it might be easier for the body to handle.
Although detailed information on the safety of mezigdomide with teclistamab is not yet available, they are being tested together, indicating some confidence in their potential safety. This is an early trial, so the main goal is to check safety and find the right dose. Participants will be closely monitored by doctors to manage any side effects.12345Why are researchers excited about this trial's treatments?
Teclistamab and Mezigdomide are unique because they combine a new approach to tackling multiple myeloma, a type of blood cancer. Most treatments for multiple myeloma, like chemotherapy and immunomodulatory drugs, focus on directly killing cancer cells or supporting the immune system in a general way. However, this combination works differently by priming the myeloma cells and specifically activating T-cells to enhance the immune system's ability to target and destroy the cancer. Researchers are excited about this approach because it offers a more targeted attack on cancer cells, potentially leading to better outcomes with fewer side effects.
What evidence suggests that combining teclistamab and mezigdomide could be an effective treatment for multiple myeloma?
Research has shown that teclistamab could be a promising treatment for people with relapsed or refractory multiple myeloma, a type of blood cancer. It has proven effective in patients who have already tried other treatments. Teclistamab targets a protein called BCMA on myeloma cells, helping the immune system attack these cancer cells. Meanwhile, mezigdomide, when used with dexamethasone (a steroid), has also demonstrated positive results in patients who have undergone many other treatments. In this trial, participants will receive a combination of teclistamab and mezigdomide, which aims to enhance the immune system's ability to fight multiple myeloma, potentially making it a strong treatment option.12356
Who Is on the Research Team?
Malin Hultcrantz, MD, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with relapsed or refractory multiple myeloma who've had at least two prior treatments, including a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Participants must have measurable disease, be willing to follow the study plan and use contraception. Those with certain infections, recent cancer therapies or transplants, serious medical conditions that could affect safety or compliance are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Mezigdomide Priming
14 days of mezigdomide priming to sensitize the myeloma cells and activate T-cells
Step-up Dosing and Combination Treatment
Step-up dosing with teclistamab followed by combination treatment with teclistamab and mezigdomide
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mezigdomide
- Teclistamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Johnson & Johnson
Industry Sponsor
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