Talquetamab for Multiple Myeloma
(MonumenTAL-1 Trial)
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?
How is the drug Talquetamab different from other treatments for multiple myeloma?
What data supports the effectiveness of the drug Talquetamab for treating multiple myeloma?
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 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive talquetamab subcutaneously at a recommended Phase 2 dose, with biweekly dosing and tocilizumab prophylaxis for CRS in some cohorts
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
What Are the Treatments Tested in This Trial?
Interventions
- Talquetamab
Talquetamab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
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