NCT02951819

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

Daratumumab Plus Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) in Previously Untreated and Relapsed Subjects With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate complete response plus (+) very good partial response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated subjects, and in relapsed subjects with multiple myeloma, as defined by the International Myeloma Working Group (IMWG) criteria.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2016-11-09
• Primary completion: 2018-03-08
• Completion: 2020-08-17
• First posted: 2016-11-01
• Last updated: 2021-10-08
• Results posted: 2019-04-03

Locations

26 sites across 1 country: United States