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CAR T-cell Therapy

Teclistamab for Multiple Myeloma (MajesTEC-1 Trial)

Phase 2

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

A female participant of childbearing potential must have a negative pregnancy test at screening

Cohorts A and D: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort C: received >= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.9 years

Awards & highlights

MajesTEC-1 Trial Summary

This trial will test how well teclistamab works in treating patients with relapsed or refractory large B-cell lymphoma.

Who is the study for?

This trial is for adults with multiple myeloma who've had at least three prior treatments including an IMiD, PI, and anti-CD38 antibody. Some must have also tried BCMA-targeted therapy. Participants need to be in good physical condition (ECOG score of 0 or 1) and women of childbearing age must test negative for pregnancy.Check my eligibility

What is being tested?

The study tests Teclistamab's effectiveness at a specific dose for those with relapsed or refractory multiple myeloma. It involves participants who meet certain treatment history criteria and are able to perform daily activities without significant assistance.See study design

What are the potential side effects?

While the side effects specific to Teclistamab aren't listed here, similar cancer drugs can cause immune reactions, fatigue, nausea, infections due to low blood cell counts, and potential infusion-related reactions.

MajesTEC-1 Trial Eligibility Criteria

Inclusion Criteria

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

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I am of childbearing age and my pregnancy test was negative.

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For Cohorts A and D, you have received at least 3 different treatments for multiple myeloma, including specific types of medications. For Cohort C, you have received at least 3 different treatments for multiple myeloma, including specific types of medications and a treatment targeting a protein called BCMA.

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My multiple myeloma can be measured by tests.

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I am fully active or can carry out light work.

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I have been diagnosed with multiple myeloma.

MajesTEC-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.9 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

Cohort D: Number of Participants with AEs by Severity

Cohort D: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Cohort D: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values

+3 more

Secondary outcome measures

Cohorts A and C: Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)

Cohorts A and C: Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)

Cohorts A and C: Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)

+15 more

MajesTEC-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: Part 3: TeclistamabExperimental Treatment1 Intervention

Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) (Cohort A and Cohort C) and will receive alternative dosing schedule of teclistamab (Cohort D).

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,114 Total Patients Enrolled

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

745 Previous Clinical Trials

3,959,711 Total Patients Enrolled

Media Library

Teclistamab (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04557098 — Phase 2

Blood Cancers Research Study Groups: Part 3: Teclistamab

Blood Cancers Clinical Trial 2023: Teclistamab Highlights & Side Effects. Trial Name: NCT04557098 — Phase 2

Teclistamab (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04557098 — Phase 2

Frequently Asked Questions

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

What potential adverse effects have been observed in patients taking Teclistamab?

"According to our team's assessment, the safety of Teclistamab can be rated as a 2. This is because it has only gone through Phase 2 trials and although there are some safety studies conducted, none have been done on its efficacy."

Answered by AI

Does this experiment present any fresh approaches?

"Teclistamab has been under investigation since 2017, when Janssen Research & Development first sponsored its Phase 1 trial of 282 patients. Subsequent trials have enabled Teclistamab to receive drug approval and currently there are 7 ongoing studies taking place across 24 different countries in 43 cities."

Answered by AI

What is the ultimate purpose of this clinical experiment?

"Over a 2.9 year span, this clinical trial aspires to measure Cohort D's serum concentration of Teclistamab. Secondary objectives include observing patient overall survival rate, number of participants impacted by adverse events (AEs), and the change in health-related quality of life recorded via EORTC QLQ-C30 questionnaire from baseline."

Answered by AI

What is the approximate cohort size of participants for this trial?

"Affirmative. Clinicaltrials.gov's records display that this medical trial, initially posted on September 17th 2020, is presently recruiting participants. 192 individuals must be enrolled from 2 different sites."

Answered by AI

Are there any existing surveys or experiments that have utilized Teclistamab?

"At present, the drug Teclistamab is being researched through 7 ongoing trials - one of which has progressed to Phase 3. The vast majority of said studies are taking place in Denver, Colorado; yet there exist a total of 401 locations running tests for this medication."

Answered by AI

Does this research initiative currently include any enrollees?

"The information currently published on clinicaltrials.gov confirms that patient recruitment is ongoing for this medical trial. This research was first posted to the site in September of 2020 and was last updated just earlier this month, November 2022."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Teclistamab in Relapsed or Refractory Multiple Myeloma

Moreau, Philippe, Alfred L. Garfall, Niels W.C.J. van de Donk, Hareth Nahi, Jesús F. San-Miguel, Albert Oriol, Ajay K. Nooka, et al.. 2022. “Teclistamab in Relapsed or Refractory Multiple Myeloma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2203478.

New England Journal of MedicineJournal

Teclistamab in Relapsed or Refractory Multiple Myeloma

clinicaltrials.govStudy

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

2020. "A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04557098.