An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

September 27, 2013

Primary Completion Date

January 9, 2015

Study Completion Date

May 30, 2017

Conditions
Multiple Myeloma
Interventions
DRUG

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

DRUG

Daratumumab 8 mg/kg (Part 1)

Daratumumab 8 mg/kg every 4 weeks (Q4W) continuously by intravenous infusion

DRUG

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

DRUG

Acetaminophen

650 to 1000 mg administered in prophylactic doses by mouth prior to study drug administration.

DRUG

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.

DRUG

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.

Trial Locations (23)

Unknown

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

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01985126 - An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD | Biotech Hunter | Biotech Hunter