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Monoclonal Antibodies

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

Phase 1
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
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
Must not have
Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year and 10 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or might have myeloma affecting my brain or spinal cord.
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I have taken a high dose of steroids equivalent to 140 mg of prednisone or more in the last two weeks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Complete Response (CR) or Better Response Rate
Duration of Response
Number of Participants with Anti-Drug Antibodies to Daratumumab
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1430
Daratumumab SC
2014
Completed Phase 3
~710
Lenalidomide
2005
Completed Phase 3
~2240
Pomalidomide
2011
Completed Phase 2
~1020

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
991 Previous Clinical Trials
6,386,685 Total Patients Enrolled
76 Trials studying Multiple Myeloma
19,827 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
757 Previous Clinical Trials
3,962,485 Total Patients Enrolled
53 Trials studying Multiple Myeloma
14,808 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
~30 spots leftby Jul 2025
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