Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab

Official Title

Daratumumab Subcutaneous Pre-approval Access Study

Brief Summary

The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.

Status

Approved for marketing

EA Type

Individual Patients

Interventions

Drug: Daratumumab

Daratumumab 1800 milligram (mg) will be administered as a fixed dose by subcutaneous (SC) injection.

Eligibility Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-

Eligibility Gender

All

Eligibility Age

Minimum: N/A ~ Maximum: N/A

Investigators

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

NCT Number

NCT04264884

MeSH Terms

Daratumumab

Disclaimer:

Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.

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