Teclistamab for Multiple Myeloma

Overseen By Christine Chen, Dr.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University Health Network, Toronto

Must not be taking: Anti-BCMA, Corticosteroids

Disqualifiers: CNS involvement, Cardiac conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

15 Participants Needed

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. ^{1 2 3 4}

Why 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. ^{5 6 7 8}

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

My condition worsened after my last treatment.

I have at least one caregiver who meets the study's requirements.

My lab results meet the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive teclistamab step-up dosing in the outpatient setting

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Cohort 3 Experimental Treatment 2 Interventions

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.

Group II: Cohort 2 Experimental Treatment 2 Interventions

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.

Group III: Cohort 1 Experimental Treatment 1 Intervention

Give teclistamab step-up dosing at Princess Margaret Cancer Centre as per product monograph.

Group IV: Caregiver Cohort Active Control 1 Intervention

Caregivers of participants in Cohorts 1, 2, and 3 will complete various questionnaires to assess impact.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Janssen Inc.

Industry Sponsor

Trials

24

Recruited

8,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12198414/

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=1

Real-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 ...

3. aacr.org aacr.org/about-the-aacr/newsroom/news-releases/real-world-data-shows-teclistamab-can-benefit-many-multiple-myeloma-patients-who-would-have-been-ineligible-for-pivotal-trial/

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 ...

4. jnj.com jnj.com/innovativemedicine/emea/media-center/press-releases/unprecedented-results-from-the-phase-3-majestec-3-study-support-tecvayli-teclistamab-plus-darzalex-daratumumab-subcutaneous-formulation-as-a-potential-standard-of-care-as-early-as-second-line-for-patients-with-relapsed-refractory-multiple-myeloma

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12290224/

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.pdf

Real-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-Effectiveness

Dosing 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.

8. nature.com nature.com/articles/s41408-025-01314-9

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.