Teclistamab Dosing for Multiple Myeloma
(MajesTEC-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Teclistamab, a monoclonal antibody, for people with multiple myeloma, a type of blood cancer. The goal is to determine a safe dose and schedule for the medication and to assess its tolerability. Participants will be divided into groups; some will receive the medication subcutaneously, while others will receive it intravenously. The trial seeks participants with multiple myeloma that has recurred or not responded to other treatments, including proteasome inhibitors and monoclonal antibodies. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before starting the study drug. You must stop monoclonal antibody treatments 21 days before, proteasome inhibitors 14 days before, and immunomodulatory agents 7 days before the first dose of the study drug.
Is there any evidence suggesting that Teclistamab is likely to be safe for humans?
Research has shown that Teclistamab has been tested for safety in adults with relapsed or hard-to-treat multiple myeloma. In the MajesTEC-1 study, 165 patients received Teclistamab. It was generally well-tolerated, but some side effects occurred, including cytokine release syndrome (CRS), where the immune system becomes overly active, and nervous system problems.
For the intravenous (IV) form of Teclistamab, similar safety concerns arose. Serious side effects like CRS and nervous system issues were noted, although many patients continued treatment for six months or more.
While Teclistamab shows promise, discussing potential risks and benefits with a healthcare provider before joining a trial is important.12345Why do researchers think this study treatment might be promising for multiple myeloma?
Unlike the standard treatments for multiple myeloma, which typically include chemotherapy, proteasome inhibitors, and immunomodulatory drugs, Teclistamab offers a novel approach by targeting BCMA (B-cell maturation antigen), a protein commonly found on myeloma cells. Researchers are excited about Teclistamab because it acts as a bispecific antibody, engaging both the myeloma cells and the patient's T-cells, effectively directing the immune system to attack the cancer. Additionally, Teclistamab can be administered both subcutaneously and intravenously, providing flexibility in treatment methods that could improve patient comfort and convenience. These features make Teclistamab a promising option for patients who might not respond well to existing therapies.
What evidence suggests that Teclistamab might be an effective treatment for multiple myeloma?
Research has shown that teclistamab holds promise for treating multiple myeloma, a type of blood cancer. Studies found that 65% of patients experienced a partial response or better, indicating improvement in their cancer. In 28% of cases, patients achieved a complete response, with no detectable signs of cancer. The treatment kept the cancer under control for an average of 11.3 months, and patients lived for an average of 18.3 months after starting treatment. These results suggest teclistamab could be effective for those with relapsed or hard-to-treat multiple myeloma. Participants in this trial will receive teclistamab either subcutaneously or intravenously, as part of different dosing strategies under evaluation.36789
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 that's come back or hasn't responded to standard treatments, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 antibody. They must be in good physical condition (ECOG score of 0 or 1), able to use birth control if necessary, and give informed consent. People who've had BCMA-targeted therapy or certain recent cancer treatments can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive Teclistamab either subcutaneously or intravenously to determine the recommended Phase 2 dose(s) and assess safety and tolerability
Dose Expansion
Participants receive Teclistamab at the recommended Phase 2 dose(s) to further evaluate safety, tolerability, and preliminary antitumor activity
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:
- Relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
- Relapsed or refractory multiple myeloma in adults who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy
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