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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))

Must not have

Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)

Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure <= 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction <= 6 m, stage III-IV congestive heart failure, etc)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.9 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

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 equivalent to 140 mg of prednisone or more in the last two weeks.

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I do not have severe lung issues, HIV, hepatitis, recent stroke or seizure, autoimmune diseases, uncontrolled infections, or serious heart conditions.

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I had a stem cell transplant from a donor within the last 6 months.

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My multiple myeloma has spread to my brain or spinal cord.

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I have been diagnosed with a specific blood disorder.

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

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

Primary study objectives

Cohorts A and C: Overall Response Rate (ORR)

Secondary study objectives

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)

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