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

NCT05161598 | Unknown

• 2 other identifiers: CR10884664007957PTL4001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Myeloma

Interventions

Teclistamab DRUG

Teclistamab will be administered subcutaneously (SC).

Also known as: JNJ-64007957

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Last Updated: December 16, 2025

Record last verified: 2025-12