510 Participants Needed

Talquetamab for Multiple Myeloma

(MonumenTAL-1 Trial)

Recruiting at 91 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 and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that any side effects from previous cancer treatments should be resolved to a certain level before starting the study drug.

Is Talquetamab safe for humans?

Talquetamab has been tested in early clinical trials for multiple myeloma, showing it is generally well-tolerated with some side effects like skin, mouth, and nail issues. It has fewer infections compared to similar treatments, indicating a favorable safety profile.12345

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

Talquetamab is unique because it is a first-in-class bispecific antibody that targets a specific protein (GPRC5D) found on cancerous plasma cells and recruits T cells to attack these cells, offering a new approach for patients with relapsed or refractory multiple myeloma.12346

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

In the MonumenTAL-1 trial, nearly 75% of patients with relapsed or refractory multiple myeloma experienced significant anticancer effects from Talquetamab, a drug that targets specific proteins on cancer cells and activates the immune system to fight the cancer.12345

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 that has come back or hasn't responded to treatment. They must be able to follow the study rules, have a certain level of physical ability (ECOG score 0-2), and women who can have children need a negative pregnancy test. People can't join if they've had a stroke or seizure recently, certain previous cancer treatments, unresolved side effects from past therapies (except hair loss or mild nerve pain), or recent high doses of steroids.

Inclusion Criteria

My multiple myeloma can be measured by tests.
Women who could become pregnant need to have a negative pregnancy test before starting the study.
Willing and able to adhere to the prohibitions and restrictions specified in this protocol
See 2 more

Exclusion Criteria

I have not had a stroke or seizure in the last 6 months.
Side effects from my past cancer treatments have mostly gone away.
I have been treated with CAR-T or T cell therapy.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive talquetamab subcutaneously at a recommended Phase 2 dose, with biweekly dosing and tocilizumab prophylaxis for CRS in some cohorts

Up to 2 years and 10 months

Open-label extension (OLE)

Participants transition to OLE phase and continue to receive study treatment

Long-term extension (LTE)

Participants transition to LTE phase and continue to receive study treatment upon approval of amendment 19

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Talquetamab
Trial Overview The study is testing Talquetamab's effectiveness and safety in patients with relapsed/refractory multiple myeloma at recommended Phase 2 doses. Participants will receive this investigational drug to see how well it works against their cancer.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Part 3: Cohort E (Talquetamab)Experimental Treatment1 Intervention
Group II: Part 3: Cohort D (Talquetamab)Experimental Treatment1 Intervention
Group III: Part 3: Cohort C (Talquetamab)Experimental Treatment1 Intervention
Group IV: Part 3: Cohort B (Talquetamab)Experimental Treatment1 Intervention
Group V: Part 3: Cohort A (Talquetamab)Experimental Treatment1 Intervention

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

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

Talquetamab, a bispecific T-cell engager targeting GPRC5D and CD3, has received accelerated approval in the USA and conditional marketing authorization in the EU for treating adults with relapsed or refractory multiple myeloma, highlighting its potential as a new treatment option.
This approval marks a significant milestone in the development of talquetamab, indicating its efficacy and safety in addressing a challenging form of cancer that has not responded to previous treatments.
Talquetamab: First Approval.Keam, SJ.[2023]
In the MonumenTAL-1 trial, nearly 75% of the 288 patients with relapsed/refractory multiple myeloma showed significant anticancer effects from the investigational drug talquetamab.
Talquetamab is a first-in-class bispecific antibody that targets GPRC5D on malignant plasma cells while sparing normal cells, effectively activating T cells to mount an immune response against the cancer.
MonumenTAL Results for Talquetamab in Myeloma.[2023]
Talquetamab, a bispecific antibody targeting GPRC5D and CD3, shows similar efficacy and durability of response in treating relapsed or refractory multiple myeloma compared to teclistamab, the first bispecific antibody approved for this condition.
While talquetamab has a lower incidence of infections than teclistamab, it presents unique side effects related to skin, oral, and nails, yet remains a well-tolerated and effective treatment option for patients with heavily pretreated multiple myeloma.
Talquetamab in multiple myeloma.Liu, L., Krishnan, A.[2023]

Citations

Talquetamab: First Approval. [2023]
MonumenTAL Results for Talquetamab in Myeloma. [2023]
Talquetamab in multiple myeloma. [2023]
Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma. [2023]
An Embarrassment of Riches: Three FDA-Approved Bispecific Antibodies for Relapsed Refractory Multiple Myeloma. [2023]
[Therapeutic monoclonal antibodies against multiple myeloma]. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security