Teclistamab for Multiple Myeloma

(MajesTEC-1 Trial)

Not currently recruiting at 72 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: Corticosteroids

Disqualifiers: Plasma cell leukemia, HIV, 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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2.9 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial tests the effectiveness of a new treatment, teclistamab, for people with multiple myeloma, a type of blood cancer. The trial focuses on patients who have already tried at least three different treatments, including specific drugs and therapies. It targets those diagnosed with multiple myeloma who have undergone several treatments and still show measurable signs of the disease. Participants will receive teclistamab through an injection to determine if it controls their cancer better than previous treatments. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.

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 there any evidence suggesting that teclistamab is likely to be safe for humans?

Research has shown that teclistamab is generally safe for people with multiple myeloma. Most patients tolerate the treatment well. Common side effects include low blood cell counts and mild infections, typical for this type of treatment and usually manageable.

Another study found that serious side effects are less common. A few patients experienced more serious infections or allergic reactions, but these were rare. Overall, teclistamab appears safe for most people, with manageable side effects, making it a promising option for treating multiple myeloma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, which often include drugs like lenalidomide or bortezomib, teclistamab is unique because it’s a bispecific antibody that specifically targets BCMA (B-cell maturation antigen) and CD3, effectively redirecting T-cells to attack the myeloma cells. This innovative mechanism of action is different from traditional therapies that primarily focus on inhibiting cancer cell growth or survival. Additionally, teclistamab is administered subcutaneously, which can be more convenient and potentially less invasive than intravenous treatments. Researchers are excited about teclistamab because it offers a novel approach that might enhance the immune system's ability to fight cancer, representing a promising advancement in multiple myeloma treatment.

What evidence suggests that teclistamab might be an effective treatment for multiple myeloma?

Research has shown that teclistamab, which participants in this trial will receive, holds promise for treating multiple myeloma, a type of blood cancer. In the MajesTec trial, about 63% of patients saw their cancer respond to teclistamab. Another study found similar results, with about 49% of patients experiencing a response. These consistent findings suggest teclistamab could be effective for many patients whose multiple myeloma has returned or is not responding to other treatments. ^{1 6 7 8 9}

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

I am of childbearing age and my pregnancy test was negative.

For Cohorts A and D, you have received at least 3 different treatments for multiple myeloma, including specific types of medications. For Cohort C, you have received at least 3 different treatments for multiple myeloma, including specific types of medications and a treatment targeting a protein called BCMA.

My multiple myeloma can be measured by tests.

Exclusion Criteria

I have taken a high dose of steroids equivalent to 140 mg of prednisone or more in the last two weeks.

I have no active cancer except for specific types considered cured or with low risk of recurrence.

I do not have severe lung issues, HIV, hepatitis, recent stroke or seizure, autoimmune diseases, uncontrolled infections, or serious heart conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive teclistamab subcutaneously at the recommended Phase 2 dose (RP2D) in Cohort A and Cohort C

Up to 2.9 years

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 tests Teclistamab's effectiveness at a specific dose for those with relapsed or refractory multiple myeloma. It involves participants who meet certain treatment history criteria and are able to perform daily activities without significant assistance.

How Is the Trial Designed?

Group I: Part 3: Teclistamab Experimental Treatment 1 Intervention

Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C.

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 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]

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]

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]

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-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]

Citations

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

Outcomes of teclistamab in patients with relapsed/ ... Treatment with SOC teclistamab yielded an ORR of 48.7% in the prior BCMA-DT group, which compares favorably with the ORR of 52.5% reported in ...

2. 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% ...

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

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11875735/

Teclistamab for relapsed or refractory multiple myeloma A 2024 report on MajesTEC-1 trial data indicated that, after a median follow-up of 30.4 months, the overall response rate remained at 63.0%, ...

6. 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.

7. 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.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40744810/

Real-World Efficacy and Safety of Teclistamab for Patients ... Given the historically poor outcomes observed in patients with triple-class exposed RRMM, teclistamab treatment should be strongly considered ...

9. 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.