124
Participants
Start Date
September 27, 2013
Primary Completion Date
January 9, 2015
Study Completion Date
May 30, 2017
Daratumumab 16 mg/kg (Part 1)
Daratumumab 16 mg/kg administered at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter by intravenous infusion
Daratumumab 8 mg/kg (Part 1)
Daratumumab 8 mg/kg every 4 weeks (Q4W) continuously by intravenous infusion
Methylprednisolone
Administered in prophylactic doses intravenously (or equivalent in accordance with local standards) prior to and after study drug administration. Intravenous administration is preferred, but oral steroids may be substituted
Acetaminophen
650 to 1000 mg administered in prophylactic doses by mouth prior to study drug administration.
Diphenhydramine
25 to 50 mg administered in prophylactic doses by mouth (or equivalent in accordance with local standards) prior to and after study drug administration.
Daratumumab (Part 2)
Based on the Part 1 response rate, Group A or B treatment will be selected as the treatment regimen for participants enrolled in Part 2.
Duarte
Los Angeles
Atlanta
Chicago
Louisville
Detroit
New Brunswick
New York
Chapel Hill
Charlotte
Portland
Philadelphia
Nashville
Houston
Madison
Calgary
Edmonton
Vancouver
Halifax
Montreal
Barcelona
Salamanca
Valencia
Janssen Research & Development, LLC
INDUSTRY