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Monoclonal Antibodies

Teclistamab Dosing for Multiple Myeloma (MajesTEC-1 Trial)

Q: Could you tell me the aggregate number of participants in this clinical experiment?

<p>Janssen Research &#x26; Development, LLC will be running this trial at various locations including Icahn School of Medicine and City of Hope. To operate the study, 282 participants that meet <a href="https://www.withpower.com/clinical-trials/all">all</a> inclusion criteria must be recruited.</p>

Q: What are the chief goals of this experiment?

<p>According to the trial's sponsor, Janssen Research &#x26; Development, LLC, safety and tolerability will be determined by measuring adverse events (AEs) over 28 days. Secondary outcomes of interest include preliminary antitumor activity as defined by International <a href="https://www.withpower.com/clinical-trials/myeloma">Myeloma</a> Working Group response criteria; Teclistamab antibodies assessment for possible immunogenicity; and biomarker evaluation in order to assess the impact of Teclistamab on patients.</p>

Phase 1

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 according to International Myeloma Working Group (IMWG) diagnostic criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years and 3 months

Awards & highlights

MajesTEC-1 Trial Summary

This trial is testing a new cancer drug to see what dose is safe for people and what side effects it has.

Who is the study for?

This trial is for adults with multiple myeloma that's come back or hasn't responded to standard treatments, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 antibody. They must be in good physical condition (ECOG score of 0 or 1), able to use birth control if necessary, and give informed consent. People who've had BCMA-targeted therapy or certain recent cancer treatments can't join.Check my eligibility

What is being tested?

The study tests Teclistamab given through IV or under the skin (SC) to find safe doses for Phase 2 trials. It aims to understand how well patients tolerate these doses while monitoring safety and side effects during treatment.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, nausea, headache, diarrhea. There may also be risks related to immune system activation like infections.

MajesTEC-1 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.

Select...

I am fully active or can carry out light work.

MajesTEC-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years and 3 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

Dose Limiting Toxicity (DLT)

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

Secondary outcome measures

Biomarker Assessment

Number of Participants with Teclistamab Antibodies

Preliminary Antitumor Activity of Teclistamab at the RP2D(s) in Part 2

+1 more

MajesTEC-1 Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion (SC)Experimental Treatment1 Intervention

Participants will receive Teclistamab SC.

Group II: Part 2: Dose Expansion (IV)Experimental Treatment1 Intervention

Participants will receive Teclistamab IV.

Group III: Part 1: Dose Escalation (SC)Experimental Treatment1 Intervention

Participants will receive Teclistamab subcutaneously (SC).

Group IV: Part 1: Dose Escalation (IV)Experimental Treatment1 Intervention

Participants will receive Teclistamab intravenously (IV).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,026 Total Patients Enrolled

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

745 Previous Clinical Trials

3,959,623 Total Patients Enrolled

Media Library

Teclistamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03145181 — Phase 1

Blood Cancers Research Study Groups: Part 1: Dose Escalation (SC), Part 2: Dose Expansion (IV), Part 2: Dose Expansion (SC), Part 1: Dose Escalation (IV)

Blood Cancers Clinical Trial 2023: Teclistamab Highlights & Side Effects. Trial Name: NCT03145181 — Phase 1

Teclistamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03145181 — Phase 1

Frequently Asked Questions

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

What other experiments have been conducted with Teclistamab(SC)?

"In 2017, the Colorado Blood Cancer Institute initiated a series of experiments with teclistamab(SC). As yet, there are no completed trials but 7 studies remain active - most notably in New york City."

Answered by AI

What health risks are associated with using Teclistamab(SC)?

"Due to its Phase 1 status, our team at Power judged Teclistamab(SC) safety level as a 1 on the scale of one to three. This reflects the fact that there is only scanty data available for this medication's efficacy and security."

Answered by AI

Could you tell me the aggregate number of participants in this clinical experiment?

"Janssen Research & Development, LLC will be running this trial at various locations including Icahn School of Medicine and City of Hope. To operate the study, 282 participants that meet all inclusion criteria must be recruited."

Answered by AI

Is there availability for participants to join this research endeavor?

"The trial, which was initially advertised in May of 2017, is still open for patient enrollment. The details posted on clinicaltrials.gov were recently modified in November 2022."

Answered by AI

What are the chief goals of this experiment?

"According to the trial's sponsor, Janssen Research & Development, LLC, safety and tolerability will be determined by measuring adverse events (AEs) over 28 days. Secondary outcomes of interest include preliminary antitumor activity as defined by International Myeloma Working Group response criteria; Teclistamab antibodies assessment for possible immunogenicity; and biomarker evaluation in order to assess the impact of Teclistamab on patients."

Answered by AI

Are any American health facilities currently conducting this investigation?

"This trial is being conducted in 5 locations, including Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects based out of New york City and Levine Cancer Institute located in Charlotte. Additionally, there are 3 other sites scattered around the nation."

Answered by AI

Is this investigation a pioneering endeavor?

"Currently, 7 live clinical trials for Teclistamab(SC) are being administered around the world in 24 countries and 43 cities. This medication's inaugural study began back in 2017 through Janssen Research & Development, LLC with a cohort of 282 participants. Subsequently, 0 additional research studies have been conducted since then."

Answered by AI

Recent research and studies

Blood AdvancesJournal

Teclistamab Is an Active T Cell–redirecting Bispecific Antibody Against B-cell Maturation Antigen for Multiple Myeloma

Pillarisetti, Kodandaram, Gordon Powers, Leopoldo Luistro, Alexander Babich, Eric Baldwin, Yingzhe Li, Xiaochun Zhang, et al.. 2020. “Teclistamab Is an Active T Cell–redirecting Bispecific Antibody Against B-cell Maturation Antigen for Multiple Myeloma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020002393.

The LancetJournal

Teclistamab, a B-cell Maturation Antigen × CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Multiple Myeloma (majestec-1): A Multicentre, Open-label, Single-arm, Phase 1 Study

Usmani, Saad Z, Alfred L Garfall, Niels W C J van de Donk, Hareth Nahi, Jesus F San-Miguel, Albert Oriol, Laura Rosinol, et al.. 2021. “Teclistamab, a B-cell Maturation Antigen × CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Multiple Myeloma (majestec-1): A Multicentre, Open-label, Single-arm, Phase 1 Study”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(21)01338-6.

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.

Targeted OncologyJournal