Teclistamab Dosing for Multiple Myeloma
(MajesTEC-1 Trial)

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.

Eligibility Criteria

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.

Inclusion Criteria

Participants must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease

My multiple myeloma has not responded to or I cannot tolerate standard treatments, and I've been treated with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

I am using birth control as a woman who can still have children.

See 2 more

Exclusion Criteria

I have taken a high dose of steroids recently.

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

Side effects from my past cancer treatments have mostly gone away.

See 2 more

Treatment Details

Interventions

Teclistamab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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).

Teclistamab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecvayli for:

Relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

🇪🇺 Approved in European Union as Tecvayli for:

Relapsed or refractory multiple myeloma in adults who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy