Teclistamab for Multiple Myeloma
(MajesTEC-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications, but it mentions that prior antitumor therapy should not be received within certain time frames before the first dose of the study drug. It's best to discuss your current medications with the trial team.
Is teclistamab safe for humans?
Teclistamab, used for treating multiple myeloma, has shown some side effects like cytokine release syndrome (a condition where the immune system releases too many proteins into the blood too quickly), infections, and neurotoxicity (damage to the nervous system). However, it is considered more tolerable for elderly patients compared to other similar treatments.12345
How is the drug Teclistamab different from other treatments for multiple myeloma?
Teclistamab is unique because it is a bispecific antibody that simultaneously targets CD3 on T cells and BCMA on myeloma cells, activating the immune system to attack the cancer. It is specifically designed for patients who have relapsed after multiple prior treatments, offering a new option with a more tolerable side effect profile for elderly patients.23467
What data supports the effectiveness of the drug Teclistamab for treating multiple myeloma?
Teclistamab has shown effectiveness in treating multiple myeloma, with a clinical trial demonstrating an overall response rate of more than 60% in patients who had already tried several other treatments. It works by activating the immune system to target and destroy cancer cells, and it has been approved by the FDA for use in patients with relapsed or refractory multiple myeloma.23456
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 multiple myeloma who've had at least three prior treatments including an IMiD, PI, and anti-CD38 antibody. Some must have also tried BCMA-targeted therapy. Participants need to be in good physical condition (ECOG score of 0 or 1) and women of childbearing age must test negative for pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive teclistamab subcutaneously at the recommended Phase 2 dose (RP2D) in Cohort A and Cohort C
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Teclistamab
Teclistamab is already approved in United States, European Union for the following indications:
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