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CAR T-cell Therapy

Teclistamab Combination Therapy for Multiple Myeloma (MajesTEC-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 documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 year and 5 months

Awards & highlights

MajesTEC-2 Trial Summary

This trial is testing the safety and tolerability of teclistamab when combined with other drugs. The goal is to find the best dose of the combination.

Who is the study for?

This trial is for adults with multiple myeloma who have measurable disease and meet specific treatment requirements. Women of childbearing potential must test negative for pregnancy and agree to ongoing tests. Participants cannot have had prior BCMA-targeted therapy (except for one regimen), recent live vaccines, high steroid doses, or active brain involvement of cancer.Check my eligibility

What is being tested?

The study is testing the safety and best dose of Teclistamab in combination with other anticancer drugs like Daratumumab, Pomalidomide, Lenalidomide, Bortezomib, and Nirogacestat in treating multiple myeloma.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, fatigue, nausea, diarrhea, fever; blood-related issues such as anemia; increased risk of infections; possible liver problems; and allergic reactions.

MajesTEC-2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My multiple myeloma diagnosis follows international guidelines.

MajesTEC-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 year and 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 year and 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 year and 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

Number of Participants with AEs by Severity

Number of Participants with Abnormalities in Laboratory Values

Number of Participants with Dose-Limiting Toxicity (DLT)

+1 more

Secondary outcome measures

Complete Response (CR) or Better Response Rate

Duration of Response

Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab

+9 more

MajesTEC-2 Trial Design

6Treatment groups

Experimental Treatment

Group I: Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)Experimental Treatment4 Interventions

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.

Group II: Treatment Regimen E: Teclistamab + Daratumumab + LenalidomideExperimental Treatment3 Interventions

Participants will receive teclistamab plus daratumumab plus lenalidomide.

Group III: Treatment Regimen D: Teclistamab + LenalidomideExperimental Treatment2 Interventions

Participants will receive teclistamab plus lenalidomide.

Group IV: Treatment Regimen C: Teclistamab + NirogacestatExperimental Treatment2 Interventions

Participants will receive teclistamab plus nirogacestat.

Group V: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)Experimental Treatment4 Interventions

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.

Group VI: Treatment Regimen A: Teclistamab + Daratumumab + PomalidomideExperimental Treatment3 Interventions

Participants will receive teclistamab plus daratumumab plus pomalidomide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daratumumab

2014

Completed Phase 3

~1860

Pomalidomide

2011

Completed Phase 2

~1020

Lenalidomide

2005

Completed Phase 3

~1480

Bortezomib

2005

Completed Phase 2

~1140

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,168 Total Patients Enrolled

70 Trials studying Multiple Myeloma

19,277 Patients Enrolled for Multiple Myeloma

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

9 Previous Clinical Trials

448,002 Total Patients Enrolled

1 Trials studying Multiple Myeloma

152 Patients Enrolled for Multiple Myeloma

Media Library

Teclistamab (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04722146 — Phase 1

Multiple Myeloma Research Study Groups: Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide, Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles), Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide, Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles), Treatment Regimen C: Teclistamab + Nirogacestat, Treatment Regimen D: Teclistamab + Lenalidomide

Multiple Myeloma Clinical Trial 2023: Teclistamab Highlights & Side Effects. Trial Name: NCT04722146 — Phase 1

Teclistamab (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722146 — Phase 1

Frequently Asked Questions

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

What are the principal objectives of this trial?

"The primary objective of this trial, to be evaluated over the course of up to 2 years and 5 months, is assessing the Number of Participants with Dose-Limiting Toxicity (DLT). Secondary goals include determining Serum Concentrations of Daratumumab as well as Very Good Partial Response (VGPR) or Better Response Rate and Complete Response (CR) or Better Response Rate through IMWG 2016 criteria."

Answered by AI

For what indications is Teclistamab commonly prescribed?

"Teclistamab has been approved to treat immunomodulation and various stages of chronic lymphocytic leukemia that have not responded adequately after two rounds of systemic chemotherapy."

Answered by AI

What is the geographic scope of this research study?

"The current trial is happening at 14 different sites, among which are Saint Louis, Hackensack and Atlanta. To reduce the travelling burden on participants, it is suggested to pick a location close by."

Answered by AI

Has Teclistamab been given regulatory approval by the FDA?

"Since this is a Phase 1 trial, which has limited data in regard to efficacy and safety, Teclistamab was assigned a score of 1 on our team's scale."

Answered by AI

Is the enrollment phase of this clinical trial still open?

"Per information provided by clinicaltrials.gov, this medical trial is currently in search of volunteers. The experiment was initially posted on March 12th 2021 and most recently updated November 3rd 2022."

Answered by AI

What is the approximate enrollment size for this clinical experiment?

"A total of 146 suitable patients are needed to take part in this medical trial. Those interested can participate at Washington University School of Medicine in Saint Louis or Hackensack University Medical Center, both located within the United States."

Answered by AI

What other analyses have been completed utilizing Teclistamab?

"Presently, there are 492 studies underway that focus on Teclistamab. Of these live trials, 88 have reached Phase 3 and most of them are based in Mishawaka, Indiana although 19734 different locations offer research opportunities for this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

2021. "A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04722146.

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