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


Study First Submitted Date 2020-02-07
Study First Posted Date 2020-02-11
Last Update Posted Date 2020-07-07
Verification Month Year July 2020
Verification Date 2020-07-31
Last Update Posted Date 2020-07-07

Browse Interventions

Sequence: 95729260 Sequence: 95729261
Mesh Term Daratumumab Mesh Term Antineoplastic Agents
Downcase Mesh Term daratumumab Downcase Mesh Term antineoplastic agents
Mesh Type mesh-list Mesh Type mesh-ancestor

Id Information

Sequence: 40028945 Sequence: 40028946
Id Source org_study_id Id Source secondary_id
Id Value CR108780 Id Value 54767414MMY4031
Id Type Other Identifier
Id Type Description Janssen Research & Development, LLC


Sequence: 52317615
Intervention Type Drug
Name Daratumumab
Description Daratumumab 1800 milligram (mg) will be administered as a fixed dose by subcutaneous (SC) injection.


Sequence: 48164172
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Janssen Research & Development, LLC

Overall Officials

Sequence: 29190133
Role Study Director
Name Janssen Research & Development, LLC Clinical Trial
Affiliation Janssen Research & Development, LLC


Sequence: 30667983
Minimum Age N/A
Maximum Age N/A
Criteria Inclusion Criteria: – Exclusion Criteria: –
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254292713
Registered In Calendar Year 2020
Were Results Reported False
Has Single Facility False

Responsible Parties

Sequence: 28781290
Responsible Party Type Sponsor