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Monoclonal Antibodies

Talquetamab + Daratumumab/Pomalidomide for Multiple Myeloma (MonumenTAL-3 Trial)

Phase 3
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
Documented multiple myeloma as defined by the International Myeloma Working Group (IMWG) diagnostic criteria
Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years 6 months
Awards & highlights

MonumenTAL-3 Trial Summary

This trial is comparing two different combinations of drugs to see which is more effective in treating patients with multiple myeloma.

Who is the study for?
This trial is for adults with Multiple Myeloma that has come back or didn't respond to treatment. They must have had at least one prior therapy including specific drugs, be relatively fit (ECOG score of 0-2), and have measurable disease. People can't join if they have brain involvement, severe allergies to drug components, high recent steroid use, certain other blood disorders, or their cancer doesn’t respond to similar treatments.Check my eligibility
What is being tested?
The study tests Talquetamab combined with Daratumumab and Pomalidomide (Tal-DP) or just Talquetamab and Daratumumab (Tal-D), against a known combo of Daratumumab with Pomalidomide and Dexamethasone (DPd). It aims to see which mix works best for treating Multiple Myeloma.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, allergic responses, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea. Each drug combination may also carry unique risks due to the different ways they work.

MonumenTAL-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition is officially diagnosed as multiple myeloma.
Select...
I've had treatment for myeloma that included a proteasome inhibitor and lenalidomide.
Select...
My condition has not improved or has worsened despite treatment.
Select...
My blood or urine tests show signs of disease.
Select...
I can take care of myself and am up and about more than half of my waking hours.

MonumenTAL-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years 6 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
Progression-Free Survival (PFS)
Secondary outcome measures
Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
+22 more

MonumenTAL-3 Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)Experimental Treatment3 Interventions
Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Group II: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)Experimental Treatment3 Interventions
Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Group III: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)Experimental Treatment4 Interventions
Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Daratumumab
2014
Completed Phase 3
~1860

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,383,476 Total Patients Enrolled
69 Trials studying Multiple Myeloma
18,569 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,095 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,574 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05455320 — Phase 3
Multiple Myeloma Research Study Groups: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd), Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP), Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05455320 — Phase 3
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05455320 — Phase 3

Frequently Asked Questions

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

At how many different medical facilities can patients participate in this clinical trial?

"The study has 27 sites with active recruitment, these include University Hospitals Cleveland Medical Center, OhioHealth, Baptist Cancer Center and 24 other locations."

Answered by AI

What is the estimated capacity of this clinical trial?

"Affirmative, the listing on clinicaltrials.gov reveals that this study is presently recruiting patients. This research project was first advertised on 10/13/2022 and updated most recently on 11/3/2022. 810 individuals are needed for the trial which will take place at 27 locations."

Answered by AI

Has Talquetamab been accepted by the FDA?

"Talquetamab's safety is estimated to be a 3. This is based off the fact that it is in Phase 3 trials, meaning that there are efficacy data as well as multiple rounds of supportive safety data."

Answered by AI

Are we still recruiting patients for this research project?

"The study, which was posted on October 13th 2020 and last updated on November 3rd 2020, is currently seeking participants."

Answered by AI
~457 spots leftby Feb 2026