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Monoclonal Antibodies

Teclistamab for Multiple Myeloma (MajesTEC-10 Trial)

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 evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria
Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Summary

"This trial aims to compare how the body processes a drug called teclistamab when it is made using the current method versus a new method."

Who is the study for?
This trial is for adults with multiple myeloma who've had 1-3 prior treatments, including specific drugs like protease inhibitors and an anti-CD38 antibody. They should have measurable disease levels and be in fair to good physical condition. Women of childbearing age must test negative for pregnancy and agree to ongoing tests.
What is being tested?
The study is testing Teclistamab, a drug for multiple myeloma, made using two different manufacturing processes. It aims to compare how the body absorbs, distributes, and gets rid of the drug from both sources.
What are the potential side effects?
Possible side effects are not detailed here but generally may include reactions at the injection site, flu-like symptoms, nausea, fatigue or allergic reactions due to changes in the production process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My last cancer treatment did not work, as confirmed by my doctor.
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I can take care of myself and am up and about more than half of my waking hours.
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I am a woman who can have children, have tested negative for pregnancy, and agree to ongoing pregnancy tests.
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I've had 1-3 prior treatments for myeloma, including specific drugs.
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I have been diagnosed with multiple myeloma and meet the specific testing criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 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
Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose
Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab
Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1
Secondary outcome measures
Number of Participants with Abnormal Laboratory Results
Number of Participants with Adverse Events (AEs) by Severity
Number of Participants with Anti-drug Antibodies (ADAs)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Post-change TeclistamabExperimental Treatment1 Intervention
Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.
Group II: Arm A: Pre-change TeclistamabExperimental Treatment1 Intervention
Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,559 Total Patients Enrolled
75 Trials studying Multiple Myeloma
19,716 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,961,359 Total Patients Enrolled
52 Trials studying Multiple Myeloma
14,697 Patients Enrolled for Multiple Myeloma
~67 spots leftby Jul 2025
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