Effects of Daratumumab Monotherapy on Bone Parameters in Patients With Relapsed and /or Refractory Multiple Myeloma

PHASE2UnknownINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

February 21, 2018

Primary Completion Date

June 20, 2019

Study Completion Date

February 20, 2020

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab

Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications prior to Daratumumab infusion to mitigate potential IRRs and post- infusion medications after Daratumumab infusion for the prevention of delayed IRRs

Trial Locations (1)

11528

RECRUITING

"General Hospital of Athens Alexandra", Athens

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

lead

Hellenic Society of Hematology

OTHER