A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

November 9, 2016

Primary Completion Date

March 8, 2018

Study Completion Date

August 17, 2020

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab

"For induction therapy cycle 1 day 1 and day 2 doses of daratumumab will be 8 milligram/kilogram (mg/kg). Starting cycle 1 week 2 until the completion of week 8 of daratumumab patients will receive 16 mg/kg Intravenously (IV) weekly.~Starting week 9 until the completion of week 24 therapy daratumumab will be administered every other week at 16 mg/kg IV.~Starting week 25 and beyond for induction therapy daratumumab will be given once every 4 weeks."

DRUG

Cyclophosphamide

Subjects will receive 4 to 8 cycles of oral cyclophosphamide 300 milligram per meter square (mg/m\^2 ) on Days 1, 8, 15, and 22 for every 28 days.

DRUG

Bortezomib

Subjects will receive 4 to 8 cycles of Bortezomib 1.5 mg/m2 subcutaneous (SC) on Days 1, 8, and 15 for every 28 days.

DRUG

Dexamethasone

Subjects will be given corticosteroids (Dexamethasone) as pre-infusion therapy prior to daratumumab and for the first 8 cycles will also receive post-infusion corticosteroids (Dexamethasone).

Trial Locations (26)

Unknown

Mobile

Phoenix

Sedona

Tucson

Fayetteville

Greenbrae

Denver

Niles

Indianapolis

Louisville

Bethesda

Columbia

Grand Rapids

Omaha

Camden

Albany

East Setauket

Fresh Meadows

Cincinnati

Eugene

Greenville

Austin

Dallas

San Antonio

Tyler

Seattle

All Listed Sponsors
lead

Janssen Scientific Affairs, LLC

INDUSTRY

NCT02951819 - A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma | Biotech Hunter | Biotech Hunter