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Monoclonal Antibodies

Teclistamab Dosing for Multiple Myeloma (MajesTEC-1 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
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
Must not have
Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years and 3 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken a high dose of steroids recently.
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My multiple myeloma has spread to my brain or spinal cord.
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I haven't had recent cancer treatments as specified before starting the study drug.
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Side effects from my past cancer treatments have mostly gone away.
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I have been treated with BCMA-targeted therapy before.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Toxicity (DLT)
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Secondary study objectives
Biomarker Assessment
Number of Participants with Teclistamab Antibodies
Preliminary Antitumor Activity of Teclistamab at the RP2D(s) in Part 2
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,601 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,980,628 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
~35 spots leftby Dec 2025
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