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NCT05463939 Clinical Trial

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

Relapsed or Refractory Multiple Myeloma Clinical Trial

Official title:
Teclistamab US Expanded Access Treatment Protocol for Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT05463939
Other study ID # CR109154
Secondary ID 64007957MMY4001
Status Approved for marketing
Phase
First received
Last updated

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

Clinical Trial Summary

The purpose of this expanded access treatment protocol is to provide patients access to teclistamab prior to market authorization. The program is limited to patients with relapsed or refractory multiple myeloma who have exhausted all treatment options available as local standard of care and who are not eligible for a teclistamab clinical trial.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient diagnosed with Relapsed or Refractory Multiple Myeloma - Patient exhausted all commercially approved and clinically appropriate (not patient or physician preference) treatment options, and is ineligible for a clinical trial

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
See also
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