Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
No longer available
CT.gov ID
NCT05161598
Collaborator
(none)
Study Details
Study Description
Brief Summary
Teclistamab pre-approval access in relapsed or refractory multiple myeloma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Expanded Access
Official Title:
PRE-APPROVAL ACCESS (PAA) Single Patient Request (SPR) TREATMENT GUIDELINES for Teclistamab (JNJ-64007957) for Treating Physician Use
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT05161598
Other Study ID Numbers:
- CR108846
- 64007957PTL4001
First Posted:
Dec 17, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Additional relevant MeSH terms: