Tec-DR and Tal-DR for Multiple Myeloma
(MajesTEC-7 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for multiple myeloma, a type of blood cancer. It aims to determine if two experimental treatment combinations, Tec-DR and Tal-DR, are more effective than the existing treatment, DRd. Participants will receive one of these combinations, involving either teclistamab or talquetamab, both alongside standard drugs daratumumab and lenalidomide. This trial targets those newly diagnosed with multiple myeloma who are unsuitable for high-dose chemotherapy and stem cell transplants due to factors like advanced age or other health conditions. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatments.
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 should not have received any prior therapy for multiple myeloma or smoldering myeloma, except for a short course of corticosteroids. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both investigational treatments—Talquetamab-Daratumumab-Lenalidomide (Tal-DR) and Teclistamab-Daratumumab-Lenalidomide (Tec-DR)—are generally safe, though they can cause some side effects.
For Tal-DR, studies have found that Talquetamab is well-tolerated. The FDA has approved it for treating relapsed or refractory multiple myeloma, indicating its safety for patients who have tried other treatments. However, some patients experienced side effects, such as infections.
For Tec-DR, trial data indicate that this combination also has a good safety record. In one study, 89.8% of patients experienced serious side effects, mainly infections. Despite these side effects, the treatment showed significant benefits.
Both treatments are in the final stages of testing, which suggests they have been shown to be safe in earlier studies. However, discussing potential risks and benefits with a healthcare provider is important before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they bring innovative approaches to the table. Unlike standard treatments that typically involve combinations like daratumumab, lenalidomide, and dexamethasone, the new arms introduce talquetamab and teclistamab. Talquetamab targets GPRC5D, a novel antigen on myeloma cells, offering a fresh mechanism of action. Similarly, teclistamab is a bispecific antibody that directs T-cells to attack myeloma cells by targeting BCMA, a different protein on the cancer cells. These unique mechanisms could potentially enhance effectiveness and provide new hope for patients who have limited options with current therapies.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that combining talquetamab with daratumumab and lenalidomide (Tal-DR), one of the treatment arms in this trial, holds promise for treating multiple myeloma. Studies have found that many patients respond well, with some even experiencing a complete disappearance of their cancer. Similarly, the combination of teclistamab with daratumumab and lenalidomide (Tec-DR), another treatment arm in this trial, demonstrated a 100% response rate in certain patient groups. Many patients also reached minimal residual disease (MRD) negativity, where no cancer cells were found in their blood. These findings suggest both combinations have strong potential for effectively treating multiple myeloma.12467
Who 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 adults with newly diagnosed multiple myeloma who can't have high-dose chemotherapy with stem cell transplant due to age or other health issues. They should be able to perform daily activities (ECOG score 0-2) and must not plan on pregnancy or fathering children during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Tec-DR or Tal-DR or DRd regimen, with cycles of 28 days each
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
- Dexamethasone
- Lenalidomide
- 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