Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)

NCT ID: NCT05161598

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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Teclistamab pre-approval access in relapsed or refractory multiple myeloma.

Detailed Description

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Conditions

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Multiple Myeloma

Interventions

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Teclistamab

Teclistamab will be administered subcutaneously (SC).

Intervention Type DRUG

Other Intervention Names

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JNJ-64007957

Eligibility Criteria

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Inclusion Criteria

Must have relapsed/refractory multiple myeloma (RRMM) and have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors \[PIs\], immunomodulatory imide drugs \[IMIDs\], anti CD38 monoclonal antibodies \[mAbs\] and therapies targeting Exportin 1 \[XPO1\] and B cell maturation antigen \[BCMA\]). Must not be eligible for a clinical trial with teclistamab or other medicines in this setting
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Other Identifiers

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64007957PTL4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108846

Identifier Type: -

Identifier Source: org_study_id