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

December 8, 2025 updated by: Janssen Research & Development, LLC

PRE-APPROVAL ACCESS (PAA) Single Patient Request (SPR) TREATMENT GUIDELINES for Teclistamab (JNJ-64007957) for Treating Physician Use

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Estimated)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108846
  • 64007957PTL4001 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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