Teclistamab for Multiple Myeloma

(MajesTEC-10 Trial)

Not currently recruiting at 63 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Protease inhibitors

Must not be taking: Bispecific antibodies, CAR-T therapy

Disqualifiers: CNS involvement, Major surgery, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to approximately 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new manufacturing process affects the absorption and use of the drug teclistamab in treating multiple myeloma, a cancer affecting blood plasma cells. Participants will receive teclistamab produced either by the current process or the new one to identify any differences. Individuals diagnosed with multiple myeloma who have undergone 1 to 3 previous treatments may be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to experience this new manufacturing process.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that teclistamab has been tested in patients with multiple myeloma, a type of blood cancer. In these studies, teclistamab was generally well-tolerated, but some risks exist. For instance, one study found that 67% of patients experienced infections, many of which were severe. This indicates that while the treatment can be effective, it may also have serious side effects.

The current trial is in an early phase, focusing on understanding the treatment's safety for people. Early trials like this one are designed to closely monitor and manage any side effects that occur.

Prospective participants should discuss with their doctor to weigh the potential benefits and risks based on their personal health situation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Teclistamab is unique because it offers a fresh approach to treating multiple myeloma by engaging the body's own immune system. Unlike traditional treatments like chemotherapy or immunomodulatory drugs, teclistamab is a bispecific antibody that targets both BCMA on myeloma cells and CD3 on T cells, effectively bringing these cells together to enhance the immune response against cancer. Researchers are excited because it represents a new mechanism of action that could potentially overcome resistance to existing therapies and offer hope to patients who have exhausted other treatment options.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that teclistamab is promising in treating multiple myeloma, a type of blood cancer. One study found that 63% of patients experienced a reduction or disappearance of their cancer. The same study reported that patients lived for an average of 11.3 months without their cancer worsening. In this trial, participants will receive teclistamab monotherapy, with some receiving the pre-change manufacturing process version and others the post-change version. Additionally, real-world evidence indicates that teclistamab helps many patients, even those who couldn't participate in earlier trials. These findings suggest that teclistamab could be effective for people with multiple myeloma. ^{6 7 8 9 10}

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 1-3 prior treatments, including specific drugs like protease inhibitors and an anti-CD38 antibody. They should have measurable disease levels and be in fair to good physical condition. Women of childbearing age must test negative for pregnancy and agree to ongoing tests.

Inclusion Criteria

My last cancer treatment did not work, as confirmed by my doctor.

I can take care of myself and am up and about more than half of my waking hours.

I've had 1-3 prior treatments for myeloma, including specific drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive teclistamab monotherapy (pre-change or post-change) until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study

Up to approximately 3 years

Cycle 1 (28 days cycle): Predose to Day 7 postdose, Cycle 3 (28 days cycle): Day 1

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 Teclistamab, a drug for multiple myeloma, made using two different manufacturing processes. It aims to compare how the body absorbs, distributes, and gets rid of the drug from both sources.

How Is the Trial Designed?

Group I: Arm B: Post-change Teclistamab Experimental Treatment 1 Intervention

Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.

Group II: Arm A: Pre-change Teclistamab Experimental Treatment 1 Intervention

Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.

Teclistamab is already approved in United States, European Union for the following indications:

Approved in United States as Tecvayli for:

• 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

Approved in European Union as Tecvayli for:

• 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

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

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

Published Research Related to This Trial

Teclistamab, a bispecific antibody for treating relapsed/refractory multiple myeloma, showed a positive exposure-response relationship for overall response rate (ORR) at the recommended phase II dose (RP2D) of 1.5 mg/kg subcutaneously weekly, based on data from 338 patients in the MajesTEC-1 study.

While factors like body weight and myeloma type influenced teclistamab's pharmacokinetics, they did not significantly affect its efficacy, indicating that the drug's effectiveness remains consistent across different patient profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. Miao, X., Wu, LS., Lin, SXW., et al.[2023]

Teclistamab-cqyv is an FDA and EMA-approved bispecific antibody that effectively targets multiple myeloma (MM) by engaging T cells to attack cancer cells, showing a 60% overall response rate in heavily pretreated relapsed/refractory patients.

This treatment is specifically designed for patients who have undergone at least three prior therapies and have shown disease progression, highlighting its role in advanced stages of MM where other treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab-cqyv in multiple myeloma. Martino, EA., Bruzzese, A., Labanca, C., et al.[2023]

Teclistamab has demonstrated strong anti-myeloma activity in patients who have severe renal impairment, indicating its potential effectiveness in a challenging patient population.

The study highlights the importance of evaluating treatments like teclistamab for their efficacy in patients with specific health conditions, such as renal issues, which can complicate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab in patients with multiple myeloma and impaired renal function. Joiner, L., Bal, S., Godby, KN., et al.[2023]

Teclistamab-cqyv is a bispecific T-cell engager antibody that effectively activates the immune system to target multiple myeloma cells, showing an overall response rate of over 60% in heavily pretreated patients.

The side effect profile of teclistamab-cqyv is more tolerable compared to other BCMA-targeted therapies, making it a suitable treatment option for elderly patients with relapsed or refractory multiple myeloma, and it has received FDA approval for use as monotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. Hua, G., Scanlan, R., Straining, R., et al.[2023]

Teclistamab is the first bispecific antibody approved for treating relapsed or refractory multiple myeloma, showing impressive efficacy in heavily pretreated patients, making it a promising option in this challenging area of treatment.

While teclistamab offers significant benefits, it also has notable adverse effects such as cytokine release syndrome, infections, and neurotoxicity, requiring careful management and precautions by healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. Pan, D., Richter, J.[2023]

In a phase 1-2 study involving 165 patients with relapsed or refractory multiple myeloma, teclistamab demonstrated a high overall response rate of 63%, with 39.4% achieving a complete response, indicating its efficacy as a treatment option for heavily pre-treated patients.

While teclistamab showed promising results, common adverse effects included cytokine release syndrome (72.1% of patients) and neutropenia (70.9%), though most toxicities were grade 1 or 2, suggesting a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab in Relapsed or Refractory Multiple Myeloma. Moreau, P., Garfall, AL., van de Donk, NWCJ., et al.[2023]

Teclistamab, a bispecific antibody targeting CD3 and BCMA, has received conditional approval in the EU and full approval in the US for treating adult patients with relapsed or refractory multiple myeloma after multiple prior therapies.

The approvals are based on its efficacy in patients who have undergone at least three to four previous treatments, including specific types of therapies, highlighting its role as a treatment option for difficult-to-treat cases of multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab: First Approval. Kang, C.[2022]

Citations

1. nature.com nature.com/articles/s41408-025-01408-4

Outcomes of relapse after teclistamab therapy in multiple ... The MajestTEC-1 trial demonstrated an overall response rate (ORR) of 63% and median progression-free survival (PFS) and OS of 11.3 and 18.3 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40352937/

Effectiveness and safety of teclistamab for relapsed or ... Teclistamab continues to be a promising and effective treatment option for RRMM patients, including those previously exposed to BCMA-targeted therapies.

3. ashpublications.org ashpublications.org/bloodadvances/article/9/19/4806/546235/The-efficacy-of-teclistamab-in-patients-with

The efficacy of teclistamab in patients with multiple myeloma ... Long-term follow-up results of the MajesTec trial have shown promising efficacy of teclistamab in RRMM with overall response rate (ORR) of 63% ...

4. tecvaylihcp.com tecvaylihcp.com/clinical-study-results/

Clinical Study Results | TECVAYLI® (teclistamab-cqyv) HCP The efficacy of TECVAYLI® was evaluated in 110 patients with relapsed or refractory multiple myeloma in the single-arm, open-label, multi-center, phase 1/2 ...

5. 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 ... Real-world Data Shows Teclistamab Can Benefit Many Multiple Myeloma Patients Who Would Have Been Ineligible for Pivotal Trial. July 9, 2025 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39090994

Safety outcomes of teclistamab accelerated dose escalation This article examines safety event rates following the implementation of a 2-day separation between step-up doses at one institution to streamline patient care.

7. 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.

8. 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.

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2203478

Teclistamab in Relapsed or Refractory Multiple Myeloma Teclistamab resulted in a high rate of deep and durable response in patients with triple-class–exposed relapsed or refractory multiple myeloma.

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e19504

Real-world outcomes of teclistamab for the treatment ... The incidence of infection was 67%; the majority were grade ≥ 3. The overall response rate (ORR) by IMWG criteria was 50%. All patients who ...