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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met