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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04264884
Expanded Access Status : Approved for marketing
First Posted : February 11, 2020
Last Update Posted : July 7, 2020
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

Drug: Daratumumab

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Daratumumab Subcutaneous Pre-approval Access Study

Resource links provided by the National Library of Medicine

Drug Information available for: Daratumumab

Intervention Details:
  • Drug: Daratumumab
    Daratumumab 1800 milligram (mg) will be administered as a fixed dose by subcutaneous (SC) injection.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult

Inclusion Criteria:


Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04264884

Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC Identifier: NCT04264884    
Other Study ID Numbers: CR108780
54767414MMY4031 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Antineoplastic Agents