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Proteasome Inhibitor

Teclistamab vs. PVd/Kd for Multiple Myeloma (MajesTEC-9 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 diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) diagnostic criteria

Received 1 to 3 prior lines of antimyeloma therapy including specific prior treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 years

Awards & highlights

MajesTEC-9 Trial Summary

This trial will compare the effectiveness of two different cancer treatments.

Who is the study for?

This trial is for people with multiple myeloma who've had 1-3 prior treatments but didn't respond well or their disease got worse. They must meet specific criteria for measurable disease, be able to follow the study's lifestyle rules, not be pregnant or breastfeeding, and have a decent ability to perform daily activities (ECOG score of 0-2). People can't join if they've had BCMA-targeted therapy before, certain allergies or conditions like CNS involvement in their cancer, recent live vaccines, or other specific blood disorders.Check my eligibility

What is being tested?

The study aims to see how effective Teclistamab alone is compared to two other treatment combinations: Pomalidomide with Bortezomib and Dexamethasone (PVd), or Carfilzomib with Dexamethasone (Kd) in treating relapsed/refractory multiple myeloma. Participants will receive one of these therapies based on random assignment.See study design

What are the potential side effects?

Teclistamab may cause infusion reactions, infections due to low white blood cell counts, tiredness, nausea. PVd/Kd treatments might lead to similar effects plus possible nerve damage from Bortezomib and heart issues from Carfilzomib.

MajesTEC-9 Trial Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma according to international standards.

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I have had 1-3 treatments for myeloma, including specific ones.

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I can take care of myself and am up and about more than half of my waking hours.

MajesTEC-9 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 years 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 EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)

Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score

Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

+16 more

MajesTEC-9 Trial Design

2Treatment groups

Experimental Treatment

Group I: TeclistamabExperimental Treatment1 Intervention

Participants will receive teclistamab monotherapy.

Group II: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)Experimental Treatment4 Interventions

Participants will receive either PVd or Kd based on principal investigator's choice.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carfilzomib

2017

Completed Phase 3

~1440

Pomalidomide

2011

Completed Phase 2

~1020

Bortezomib

2005

Completed Phase 2

~1090

Dexamethasone

2007

Completed Phase 4

~2590

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,102 Total Patients Enrolled

70 Trials studying Multiple Myeloma

18,872 Patients Enrolled for Multiple Myeloma

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

746 Previous Clinical Trials

3,959,688 Total Patients Enrolled

49 Trials studying Multiple Myeloma

13,839 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Research Study Groups: Teclistamab, Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)

Frequently Asked Questions

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

Are enrollees still being accepted for this research study?

"No, this particular study is not recruiting new patients at the moment. Although, it should be noted that the trial was last updated on November 3rd, 2022 and there are 826 other trials with active recruitment drives."

Answered by AI

Is this study widely available in Canada?

"Including but not limited to, Virginia Commonwealth University - Massey Cancer Center in Richmond, Tom Baker Cancer Centre in Calgary, and Juravinski Cancer Centre in Hamilton; there are 7 medical centres currently running this study."

Answered by AI

Could you please explain the potential risks associated with taking Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)?

"Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) have both undergone multiple rounds of testing to prove their safety, so they received a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

2023. "A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05572515.