795 Participants Needed

Talquetamab Combinations for Multiple Myeloma

(MonumenTAL-6 Trial)

Recruiting at 255 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two new drug combinations to treat multiple myeloma. The combinations include talquetamab with either pomalidomide or teclistamab. These drugs help the immune system better identify and destroy cancer cells. The goal is to see if these new combinations work better than existing treatments.

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 Talquetamab safe for humans?

Talquetamab has been shown to be generally well-tolerated in clinical trials for multiple myeloma, with fewer infections compared to similar treatments, but it can cause side effects like skin, mouth, and nail issues. Teclistamab, a similar drug, has side effects such as cytokine release syndrome (a severe immune reaction), infections, and nerve problems, but is considered more tolerable for older patients.12345

What makes the drug Talquetamab combined with Teclistamab unique for treating multiple myeloma?

Talquetamab and Teclistamab are unique because they are bispecific antibodies that engage T-cells to target specific proteins on multiple myeloma cells, with Talquetamab targeting GPRC5D and Teclistamab targeting BCMA. This dual targeting approach is novel and offers a new option for patients who have relapsed or are resistant to other treatments.12356

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

Talquetamab has shown significant anticancer effects in nearly three-quarters of patients with relapsed or refractory multiple myeloma in a clinical trial, and it has been granted accelerated approval in the USA and conditional marketing authorization in the EU for this condition.12578

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 people with multiple myeloma that has come back or hasn't responded to treatment, including an anti-CD38 antibody and lenalidomide. Participants should be fairly active (ECOG score of 0-2), not pregnant or planning pregnancy soon, and have measurable disease levels according to specific medical criteria.

Inclusion Criteria

You cannot be pregnant, breastfeeding, or planning to get pregnant during the study or within 6 months after the study treatment.
My cancer came back or didn't respond well to treatment.
I have been diagnosed with multiple myeloma and meet the specific blood or urine test criteria.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Talquetamab plus Pomalidomide (Tal-P), Talquetamab plus Teclistamab (Tal-Tec), or Investigator's choice of Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd)

Up to 6 years 5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Talquetamab
  • Teclistamab
Trial Overview The study compares the effectiveness of talquetamab with pomalidomide (Tal-P) or talquetamab with teclistamab (Tal-Tec) against two other drug combinations: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd).
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Talquetamab + Teclistamab (Tal-Tec)Experimental Treatment3 Interventions
Group II: Arm A: Talquetamab + Pomalidomide (Tal-P)Experimental Treatment3 Interventions
Group III: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)Active Control4 Interventions

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

🇺🇸
Approved in United States as Talquetamab for:
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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

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]
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]
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]
Talquetamab: First Approval. [2023]
Teclistamab-cqyv in multiple myeloma. [2023]
MonumenTAL Results for Talquetamab in Myeloma. [2023]
The emerging therapeutic landscape of relapsed/refractory multiple myeloma. [2023]
Talquetamab in multiple myeloma. [2023]
Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. [2023]
Teclistamab: First Approval. [2022]
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