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NCT05161598 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT05161598
Other study ID # CR108846
Secondary ID 64007957PTL4001
Status No longer available
Phase
First received
Last updated

Study information
Verified date August 2022
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Teclistamab
Teclistamab will be administered subcutaneously (SC).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Janssen Research & Development, LLC
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