Teclistamab for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the best method for administering teclistamab, a type of immunotherapy, to patients with relapsed or refractory multiple myeloma in an outpatient setting. It also examines the impact of this treatment on the caregivers who assist these patients. Candidates may qualify if their multiple myeloma has worsened after trying at least three different treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you stop taking other myeloma therapies, including corticosteroids, within 3 days of starting teclistamab. If you are on other medications, it's best to discuss with the study team to see if they are allowed.
What is the safety track record for teclistamab?
Research has shown that teclistamab has undergone safety testing in patients with multiple myeloma. In one study, a common reaction to immunotherapy, cytokine release syndrome (CRS), was reported in 48-50% of patients. Another side effect, immune effector cell-associated neurotoxicity syndrome (ICANS), which affects the brain, occurred in 17% of patients. Such side effects often occur with treatments like teclistamab that activate the immune system.
In real-world use, teclistamab has proven effective for many people with relapsed or refractory multiple myeloma. This indicates successful use outside of clinical trials, providing more information about its safety and effectiveness.
Overall, these findings suggest that while teclistamab can cause side effects, it is being used safely in many cases. As always, discussing any concerns with a healthcare provider is important.1234Why are researchers excited about this trial?
Researchers are excited about teclistamab for multiple myeloma because it offers a novel approach by engaging T-cells to target and destroy cancer cells. Unlike traditional treatments like proteasome inhibitors and immunomodulatory drugs, teclistamab is a bispecific antibody that binds to both CD3 on T-cells and BCMA on myeloma cells, directing the immune system to attack the cancer. This unique mechanism has the potential to improve patient outcomes by harnessing the body's own immune defenses, which could lead to more effective and targeted therapies for those battling this challenging condition.
What is the effectiveness track record for teclistamab in treating multiple myeloma?
Research has shown that teclistamab effectively treats relapsed multiple myeloma. In some studies, 63% of patients experienced a reduction or disappearance of their cancer. Additionally, about 40% of patients achieved a "very good partial response," indicating a significant decrease in their cancer. Another study found that more than 90% of patients who were stable at six months remained stable at three years. This trial will evaluate teclistamab using different dosing strategies across various cohorts, suggesting that teclistamab can be a strong option for patients previously treated for multiple myeloma.5678
Who Is on the Research Team?
Christine Chen, Dr.
Principal Investigator
University Health Network, Toronto
Are You a Good Fit for This Trial?
This trial is for adults over 18 with relapsed or refractory multiple myeloma who've had at least three prior treatments, including specific inhibitors and antibodies. They must have progressed after the last treatment and agree to receive care at specified cancer centers. Participants need a caregiver, meet lab value criteria, not be too frail, and use reliable contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive teclistamab step-up dosing in the outpatient setting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Teclistamab
Trial Overview
The study is testing an outpatient process for administering Teclistamab to those with multiple myeloma. It also assesses caregiver burden. Teclistamab is given alongside Tocilizumab to manage side effects in patients who've tried other therapies without success.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Give teclistamab step-up dosing at Southlake Regional Cancer Centre in the outpatient setting using the best method(s) as determined from Cohorts 1 and 2.
Give teclistamab step-up dosing at Princess Margaret Cancer Centre with the addition of one dose of prophylactic tocilizumab prior to step-up dose 1.
Give teclistamab step-up dosing at Princess Margaret Cancer Centre as per product monograph.
Caregivers of participants in Cohorts 1, 2, and 3 will complete various questionnaires to assess impact.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Janssen Inc.
Industry Sponsor
Citations
Outcomes of teclistamab in patients with relapsed/ ...
The median overall PFS for all patients with BCMA-DT was 4.8 months, closely aligning with our findings, and the 9-month OS rate was 60% [27].
2.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/7596/554677/Real-world-outcomes-of-teclistamab-for-multiple?searchresult=1Real-world outcomes of teclistamab for multiple myeloma in ...
Introduction: Teclistamab is a highly effective treatment for relapsed multiple myeloma (MM), with an overall response rate (ORR) of 63% and ...
Real-world Data Shows Teclistamab Can Benefit Many ...
Forty percent exhibited “very good partial responses,” including 43% of the 58 patients whose disease had been previously treated with the ...
Unprecedented results from the Phase 3 MajesTEC ...
More than 90 percent of patients who were progression-free at six months (n=249) remained progression-free at three years.1. The study evaluated ...
Safety outcomes of teclistamab accelerated dose escalation
CRS occurred in 48% (11) of patients for the accelerated dosing and 50% (2) for the standard dosing group. ICANS was seen in 17% (4) of patients ...
6.
jnjmedicalconnect.com
jnjmedicalconnect.com/media/attestation/congresses/oncology/2025/ims/realworld-longterm-effectiveness-and-safety-outcomes-among-patients-receiving-teclistamab-for-the-tr.pdfReal-World Long-Term Effectiveness and Safety Outcomes ...
In the real-world, teclistamab is effective in a wide range of patients with relapsed/refractory multiple myeloma (RRMM), including those who are older, more ...
7.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/2398/532408/Dosing-Patterns-and-Early-Safety-and-EffectivenessDosing Patterns and Early Safety and Effectiveness Outcomes ...
Dosing patterns and early safety and effectiveness outcomes in patients with multiple myeloma treated with Teclistamab in the community setting.
Outcomes of teclistamab in patients with relapsed/ ...
Data describing outcomes of teclistamab in multiple myeloma patients with prior exposure to BCMA-directed therapy (BCMA-DT) are limited.
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