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CAR T-cell Therapy

Talquetamab for Multiple Myeloma (MonumenTAL-1 Trial)

Phase 2
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
Measurable disease cohort A, cohort B, cohort C, and cohort D: multiple myeloma must be measurable by central laboratory assessment
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 2 years and 10 months
Awards & highlights

MonumenTAL-1 Trial Summary

This trial will study whether talquetamab can help treat people with multiple myeloma that has gotten worse after other treatments or that never responded to other treatments.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not specified here, common side effects for cancer treatments like Talquetamab may include fatigue, nausea, immune system reactions, infusion-related reactions, and potential impacts on blood counts leading to increased infection risk.

MonumenTAL-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My multiple myeloma can be measured by tests.
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My multiple myeloma diagnosis follows international guidelines.
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I can take care of myself and am up and about more than half of my waking hours.

MonumenTAL-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years and 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 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
Overall Response Rate (ORR)
Secondary outcome measures
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
+15 more

MonumenTAL-1 Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 3: Cohort D (Talquetamab)Experimental Treatment1 Intervention
Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
Group II: Part 3: Cohort C (Talquetamab)Experimental Treatment1 Intervention
Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
Group III: Part 3: Cohort B (Talquetamab)Experimental Treatment1 Intervention
Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.
Group IV: Part 3: Cohort A (Talquetamab)Experimental Treatment1 Intervention
Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,858 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,455 Total Patients Enrolled

Media Library

Talquetamab (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04634552 — Phase 2
Blood Cancers Research Study Groups: Part 3: Cohort C (Talquetamab), Part 3: Cohort D (Talquetamab), Part 3: Cohort B (Talquetamab), Part 3: Cohort A (Talquetamab)
Blood Cancers Clinical Trial 2023: Talquetamab Highlights & Side Effects. Trial Name: NCT04634552 — Phase 2
Talquetamab (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634552 — Phase 2

Frequently Asked Questions

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

How many healthcare facilities are currently conducting this research?

"Patients can join this trial at various medical centres, including the University of Alabama Birmingham in Birmingham, Arkansas for Medical Sciences in Little Rock, and Rochester Medical Center in Rochester. Additionally, there are 13 other sites that are also participating."

Answered by AI

Are there any records of further experimentation involving Talquetamab?

"Talquetamab was first investigated in 2017 at Hosp. Clinico Univ. de Salamanca, with no completed trials to-date. Currently, 6 active studies are underway primarily located within Birmingham, Alabama."

Answered by AI

Has Talquetamab received governmental sanction as a therapeutic option?

"While clinical data has not yet established efficacy, Talquetamab's safety is supported by prior research and thus it receives a rating of 2."

Answered by AI

Is this experiment still open to additional participants?

"Affirmative. Clinicaltrials.gov's data confirms that this clinical trial, first posted on February 1st 2021, is actively recruiting participants. 320 patients must be recruited from 13 different healthcare institutions across the country."

Answered by AI

What is the sample size of this clinical experiment?

"This medical trial requires 320 consenting individuals that meet the requisite criteria. Participating patients can join from various parts of the country, such as University of Alabama Birmingham in Birmingham or University of Arkansas for Medical Sciences in Little Rock."

Answered by AI

Has this experiment been attempted previously?

"Talquetamab has been subject to clinical trials since 2017, the first of which was supported by Janssen Research & Development. After Phase 1 approval in 2017 following a study involving 260 participants, 6 current studies are taking place across 40 cities and 14 countries globally."

Answered by AI
~170 spots leftby Mar 2026