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CAR T-cell Therapy

Arm B: Talquetamab + Teclistamab (Tal-Tec) for Multiple Myeloma (MonumenTAL-6 Trial)

Q: Has Arm B, which consists of Talquetamab and Teclistamab (also known as Tal-Tec), received approval from the FDA?

Our team at Power has evaluated the safety of Arm B, which involves Talquetamab + Teclistamab (Tal-Tec), to be rated as 3. This assessment is based on the trial being in Phase 3, signifying existing efficacy data and robust safety evidence from various iterations.

Q: In how many distinct settings is this research study being conducted?

Currently, this clinical research is ongoing at 19 sites including Genk, Almere, and Darlinghurst among other undisclosed locations. Opting for the nearest site when enrolling can reduce travel obligations.

Q: Are participants being actively sought for this ongoing research study?

Indeed, details on clinicaltrials.gov confirm the ongoing patient recruitment for this particular trial. The study was initially listed on 1/22/2024 and most recently revised on 2/27/2024. Approximately 795 patients are sought from a total of 19 locations.

Q: What is the current number of individuals actively participating in this clinical investigation?

Affirmative. Data on clinicaltrials.gov confirms the ongoing patient recruitment for this study, which was first listed on January 22nd, 2024 and last modified on February 27th, 2024. The trial aims to enroll a total of 795 participants across 19 designated sites.

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 criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio

Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years 5 months

Awards & highlights

MonumenTAL-6 Trial Summary

"This trial aims to see which treatment is more effective: either talquetamab plus pomalidomide or talquetamab plus teclistamab, compared to a combination of elot

Who is the study for?

This trial is for people with multiple myeloma that has come back or hasn't responded to treatment, including an anti-CD38 antibody and lenalidomide. Participants should be fairly active (ECOG score of 0-2), not pregnant or planning pregnancy soon, and have measurable disease levels according to specific medical criteria.Check my eligibility

What is being tested?

The study compares the effectiveness of talquetamab with pomalidomide (Tal-P) or talquetamab with teclistamab (Tal-Tec) against two other drug combinations: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd).See study design

What are the potential side effects?

Possible side effects include immune system reactions, infections, fatigue, nausea, nerve damage from Bortezomib, blood clots from Pomalidomide, high blood sugar from Dexamethasone, and infusion-related reactions.

MonumenTAL-6 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with multiple myeloma and meet the specific blood or urine test criteria.

Select...

My cancer came back or didn't respond well to treatment.

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I can care for myself and am up and about more than 50% of my waking hours.

MonumenTAL-6 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years 5 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 Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30

Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L

Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey

+17 more

MonumenTAL-6 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Talquetamab + Teclistamab (Tal-Tec)Experimental Treatment3 Interventions

Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.

Group II: Arm A: Talquetamab + Pomalidomide (Tal-P)Experimental Treatment3 Interventions

Participants will receive talquetamab as subcutaneous (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.

Group III: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)Active Control4 Interventions

Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Pomalidomide

2011

Completed Phase 2

~1020

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,383,897 Total Patients Enrolled

70 Trials studying Multiple Myeloma

18,667 Patients Enrolled for Multiple Myeloma

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

746 Previous Clinical Trials

3,959,483 Total Patients Enrolled

49 Trials studying Multiple Myeloma

13,634 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.

Has Arm B, which consists of Talquetamab and Teclistamab (also known as Tal-Tec), received approval from the FDA?

"Our team at Power has evaluated the safety of Arm B, which involves Talquetamab + Teclistamab (Tal-Tec), to be rated as 3. This assessment is based on the trial being in Phase 3, signifying existing efficacy data and robust safety evidence from various iterations."

Answered by AI

In how many distinct settings is this research study being conducted?

"Currently, this clinical research is ongoing at 19 sites including Genk, Almere, and Darlinghurst among other undisclosed locations. Opting for the nearest site when enrolling can reduce travel obligations."

Answered by AI

Are participants being actively sought for this ongoing research study?

"Indeed, details on clinicaltrials.gov confirm the ongoing patient recruitment for this particular trial. The study was initially listed on 1/22/2024 and most recently revised on 2/27/2024. Approximately 795 patients are sought from a total of 19 locations."

Answered by AI

What is the current number of individuals actively participating in this clinical investigation?

"Affirmative. Data on clinicaltrials.gov confirms the ongoing patient recruitment for this study, which was first listed on January 22nd, 2024 and last modified on February 27th, 2024. The trial aims to enroll a total of 795 participants across 19 designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

2024. "A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06208150.