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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
Must not have
Stroke or seizure within 6 months prior to signing the informed consent form (ICF)
Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years and 10 months
Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a stroke or seizure in the last 6 months.
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Side effects from my past cancer treatments have mostly gone away.
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I have taken a high dose of steroids recently.

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

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.

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Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,383,843 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,497 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 B (Talquetamab), Part 3: Cohort D (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
~148 spots leftby Mar 2026
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