Talquetamab + Teclistamab for Multiple Myeloma
(RedirecTT-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for people with multiple myeloma, a type of blood cancer, particularly for those whose cancer has returned or is difficult to treat. Researchers aim to determine the optimal dose and schedule for using the drugs talquetamab (also known as Talvey), teclistamab, and sometimes daratumumab. They seek to assess whether this combination is safe and effective in shrinking the cancer, especially in cases where the disease has spread outside the bone marrow. Individuals diagnosed with multiple myeloma who have not responded to other treatments might be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
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 mention that you cannot have had targeted therapy, epigenetic therapy, or investigational treatments within 21 days before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using talquetamab and teclistamab together is as safe as using each one separately, with similar side effects whether used alone or in combination. Other studies have reported common side effects such as infections and blood issues, which were usually manageable.
When daratumumab is added, safety remains consistent. This combination has been studied, and while it can cause side effects like infections, these are common and expected for such treatments. Importantly, these treatments have shown promise for patients whose previous multiple myeloma treatments were ineffective.
This trial is in the early stages, focusing mainly on understanding the treatment's safety. Although some risks exist, the studies are designed to carefully monitor and manage them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they leverage innovative bispecific antibodies, talquetamab and teclistamab, which are designed to engage the immune system more effectively. Unlike standard therapies like chemotherapy and proteasome inhibitors, talquetamab targets GPRC5D, a novel antigen found on multiple myeloma cells, while teclistamab targets the BCMA antigen, both guiding the immune system to attack cancer cells more precisely. Combining these antibodies with daratumumab, which targets CD38, could enhance the treatment's effectiveness by simultaneously attacking multiple targets on cancer cells. This multi-targeted approach has the potential to overcome resistance to existing treatments and improve patient outcomes.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that the combination of talquetamab and teclistamab, which participants in this trial may receive, holds promise for treating relapsed or hard-to-treat multiple myeloma, particularly in patients whose cancer has spread outside the bone marrow. One study found that 79% of patients responded to this treatment, with about 52% experiencing a complete response, meaning their cancer became undetectable after treatment.
In this trial, some participants will receive a combination of daratumumab, talquetamab, and teclistamab. Studies indicate that this combination can delay cancer progression, helping to control the disease for a longer time. In some instances, all patients responded to the treatment, showing a 100% response rate. These findings support the effectiveness of these treatment combinations in managing multiple myeloma.12367Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for people with multiple myeloma that's come back or hasn't responded to treatment. They should be able to perform daily activities without significant issues (ECOG grade 0-1). Participants must have been diagnosed according to specific criteria and can't join if they've had certain other conditions, recent experimental therapies, or a stem cell transplant within the last six months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study drug combination of talquetamab and teclistamab, with or without daratumumab, in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes and survival
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
- Talquetamab
- Teclistamab
Daratumumab is already approved in European Union, United States for the following indications:
- Relapsed and refractory multiple myeloma
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Multiple myeloma in patients who have received at least three prior therapies
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University