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Monoclonal Antibodies

Talquetamab Combination Therapy for Multiple Myeloma (MonumenTAL-2 Trial)

Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration
Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year and 10 months
Awards & highlights

MonumenTAL-2 Trial Summary

This trial is testing the safety of a new drug, talquetamab, given in different combinations. They hope to find a safe dose of the drug to use in future.

Who is the study for?
This trial is for individuals with confirmed multiple myeloma who can follow the study's lifestyle restrictions, including pregnancy prevention plans. They must have measurable disease indicators and be in good physical condition (ECOG score of 0 or 1). Women of childbearing potential need a negative pregnancy test before starting treatment.Check my eligibility
What is being tested?
The study tests Talquetamab combined with other cancer drugs like Carfilzomib, Daratumumab SC, Lenalidomide, and Pomalidomide to find safe doses and assess safety. It aims to understand how well these combinations work for treating multiple myeloma.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, kidney issues from high protein levels caused by dying cancer cells (tumor lysis syndrome), and nerve damage symptoms.

MonumenTAL-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My multiple myeloma diagnosis follows international guidelines.

MonumenTAL-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year and 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year and 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
+1 more
Secondary outcome measures
Complete Response (CR) or Better Response Rate
Duration of Response
Number of Participants with Anti-Drug Antibodies to Daratumumab
+8 more

MonumenTAL-2 Trial Design

5Treatment groups
Experimental Treatment
Group I: Treatment Regimen E: Talquetamab + PomalidomideExperimental Treatment2 Interventions
Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.
Group II: Treatment Regimen D: Talquetamab + Daratumumab + LenalidomideExperimental Treatment3 Interventions
Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.
Group III: Treatment Regimen C: Talquetamab + LenalidomideExperimental Treatment2 Interventions
Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.
Group IV: Treatment Regimen B: Talquetamab + Daratumumab + CarfilzomibExperimental Treatment3 Interventions
Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.
Group V: Treatment Regimen A: Talquetamab + CarfilzomibExperimental Treatment2 Interventions
Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Lenalidomide
2005
Completed Phase 3
~1480
Pomalidomide
2011
Completed Phase 2
~1020

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,126 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,235 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,723 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,202 Patients Enrolled for Multiple Myeloma

Media Library

Talquetamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05050097 — Phase 1
Multiple Myeloma Clinical Trial 2023: Talquetamab Highlights & Side Effects. Trial Name: NCT05050097 — Phase 1
Talquetamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05050097 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are the maximum allowable for this research experiment?

"Affirmative. According to clinicaltrials.gov, this research venture is presently recruiting patients; it was initially submitted on September 22nd 2021 and has been updated as recently as November 3rd 2022. The protocol requires the recruitment of 176 volunteers at 12 distinct sites."

Answered by AI

What sort of results is this research looking to achieve?

"According to the research sponsor, Janssen Research & Development, LLC, the primary outcome assessed over a Up to 1 year and 6 months time frame will be Number of Participants with Dose Limiting Toxicity (DLT). This trial is also set to monitor secondary outcomes such as Very Good Partial Response (VGPR) or Better Response Rate which measures whether participants achieved a VGPR or better response according to established criteria; Complete Response (CR) or Better Response Rate measuring CR or higher responses based on IMWG 2016 guidelines; and finally, assessing for anti-drug antibodies among patients being treated with daratumumab."

Answered by AI

What is the principal application of Talquetamab?

"The most common use for Talquetamab is to treat patients that have experienced two prior systemic chemotherapy regimens. This medication can also be employed in the management of amyloidosis, refractory multiple myeloma and cell transplants."

Answered by AI

Have any other investigations been conducted utilizing Talquetamab?

"At the moment, there are 444 clinical trials researching Talquetamab with 78 in Phase 3. Although most of these studies occur near Chicago, Illinois, a total of 18450 sites facilitate research on this medication."

Answered by AI

What is the prevalence of this research program in North American medical facilities?

"This clinical trial is being conducted in a total of 12 different places, with locations such as Birmingham, San Francisco and Hackensack. To reduce the amount of travel required for participation, it is ideal to pick the closest medical centre possible."

Answered by AI

Are there any openings for participants in this trial?

"Correct. Clinicaltrials.gov displays that this clinical research, first published on September 22nd 2021 is actively recruiting participants. 176 individuals from 12 trial sites need to be included in the study."

Answered by AI

Are there known risks associated with Talquetamab utilization?

"Given the limited amount of safety and efficacy data, Talquetamab was rated a 1 on our team's scale from one to three."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
2021. "A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05050097.
~57 spots leftby Jul 2025
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