194 Participants Needed

Teclistamab for Multiple Myeloma

(MajesTEC-1 Trial)

Recruiting at 64 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

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 teclistamab safe for humans?

Teclistamab, used for treating multiple myeloma, has shown some side effects like cytokine release syndrome (a condition where the immune system releases too many proteins into the blood too quickly), infections, and neurotoxicity (damage to the nervous system). However, it is considered more tolerable for elderly patients compared to other similar treatments.12345

How is the drug Teclistamab different from other treatments for multiple myeloma?

Teclistamab is unique because it is a bispecific antibody that simultaneously targets CD3 on T cells and BCMA on myeloma cells, activating the immune system to attack the cancer. It is specifically designed for patients who have relapsed after multiple prior treatments, offering a new option with a more tolerable side effect profile for elderly patients.23467

What data supports the effectiveness of the drug Teclistamab for treating multiple myeloma?

Teclistamab has shown effectiveness in treating multiple myeloma, with a clinical trial demonstrating an overall response rate of more than 60% in patients who had already tried several other treatments. It works by activating the immune system to target and destroy cancer cells, and it has been approved by the FDA for use in patients with relapsed or refractory multiple myeloma.23456

Who Is on the Research Team?

JR

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.
See 3 more

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.
See 8 more

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?
1Treatment groups
Experimental Treatment
Group I: Part 3: TeclistamabExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Tecvayli for:
🇪🇺
Approved in European Union as Tecvayli for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

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-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.
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, 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.
Teclistamab: First Approval.Kang, C.[2022]
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.
Teclistamab-cqyv in multiple myeloma.Martino, EA., Bruzzese, A., Labanca, C., et al.[2023]

Citations

Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. [2023]
Teclistamab: First Approval. [2022]
Teclistamab-cqyv in multiple myeloma. [2023]
Teclistamab in patients with multiple myeloma and impaired renal function. [2023]
Teclistamab in Relapsed or Refractory Multiple Myeloma. [2023]
Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. [2023]
Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. [2023]
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