Teclistamab vs. PVd/Kd for Multiple Myeloma
(MajesTEC-9 Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing teclistamab, an antibody that helps the immune system find and destroy cancer cells, in patients with multiple myeloma who have not responded to previous treatments. It works by connecting immune cells with cancer cells to help destroy them. Teclistamab has shown promising results in early trials.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you've recently taken certain medications like strong CYP3A4 inducers or have received a live vaccine within 4 weeks before randomization.
What data supports the effectiveness of the drug Carfilzomib for treating multiple myeloma?
What safety information is available for the treatments in the Teclistamab vs. PVd/Kd trial for Multiple Myeloma?
The treatments in the trial, including bortezomib, carfilzomib, pomalidomide, and dexamethasone, have been studied for safety in multiple myeloma patients. Common side effects include anemia (low red blood cell count), neutropenia (low white blood cell count), and thrombocytopenia (low platelet count), with some patients experiencing infections due to weakened immune systems. Serious side effects like pneumonia and pulmonary embolism have been reported, but the treatments are generally considered well-tolerated.678910
What makes the drug Teclistamab unique for treating multiple myeloma?
Teclistamab is unique because it is a bispecific antibody that targets both BCMA (B-cell maturation antigen) on myeloma cells and CD3 on T-cells, helping the immune system directly attack the cancer cells, which is different from traditional chemotherapy drugs that target the cancer cells more broadly.610111213
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for people with multiple myeloma who've had 1-3 prior treatments but didn't respond well or their disease got worse. They must meet specific criteria for measurable disease, be able to follow the study's lifestyle rules, not be pregnant or breastfeeding, and have a decent ability to perform daily activities (ECOG score of 0-2). People can't join if they've had BCMA-targeted therapy before, certain allergies or conditions like CNS involvement in their cancer, recent live vaccines, or other specific blood disorders.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive either teclistamab monotherapy or PVd/Kd based on the principal investigator's choice
Treatment Part 2
Participants receive an alternative dosing regimen of teclistamab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bortezomib
- Carfilzomib
- Dexamethasone
- Pomalidomide
- Teclistamab
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires