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Monoclonal Antibody

Talquetamab for Multiple Myeloma (MonumenTAL-5 Trial)

Phase 3

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

MonumenTAL-5 Trial Summary

This trial will compare the effectiveness of two different drugs for treating cancer.

Eligible Conditions

Multiple Myeloma

MonumenTAL-5 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Progression-free Survival (PFS)

Secondary outcome measures

Change from Baseline in EuroQol 5-Dimension Questionnaire 5-Level (EQ-5D-5L)

Change from Baseline in EuroQol 5-Dimension Questionnaire 5-Level (FACT-G)

Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

+13 more

MonumenTAL-5 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: TalquetamabExperimental Treatment1 Intervention

Participants will receive talquetamab subcutaneously (SC).

Group II: Arm B: Belantamab MafodotinActive Control1 Intervention

Participants will receive belantamab intravenously (IV).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,308 Total Patients Enrolled

70 Trials studying Multiple Myeloma

19,417 Patients Enrolled for Multiple Myeloma

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,905 Total Patients Enrolled

49 Trials studying Multiple Myeloma

14,384 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Are there any safety concerns that come with Talquetamab?

"Talquetamab is classified as safe by our team at Power, with a score of 3. This is due to Phase 3 trials returning data that suggest efficacy as well as multiple rounds of data that support safety."

Answered by AI

Are you looking for more people to enroll in this experiment?

"The clinicaltrials.gov website indicates that this study is not currently recruiting patients. This trial was first posted on November 8th, 2022 and was last edited on October 13th, 2022. Although this particular trial has completed recruitment, there are 826 other trials which are still looking for participants."

Answered by AI

What is the main purpose of this clinical trial?

"The primary goal of this study, which will be evaluated over the course of 1 year and 3 months, is to observe the progression-free survival rate of patients. Additionally, we will also be measuring secondary outcomes including the time it takes for sustained worsening in the EORTC-QLQ-C30 and EQ-5D-5L, as well as changes from baseline in the EuroQol 5-Dimension Questionnaire 5-Level and EQ-5D-5L."

Answered by AI

How many different hospitals or research centers are conducting this trial?

"There are a total of 29 sites where this study is taking place. In addition to University of Pennsylvania in Philadelphia and New jersey Hematology Oncology Ass. in Brick, Nova Scotia Health Authority in Halifax, there are 26 other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma

2022. "A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05461209.