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

NCT ID: NCT04264884

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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

Detailed Description

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Interventions

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Daratumumab

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Other Identifiers

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54767414MMY4031

Identifier Type: OTHER

Identifier Source: secondary_id

CR108780

Identifier Type: -

Identifier Source: org_study_id

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