Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

February 15, 2018

Primary Completion Date

March 22, 2021

Study Completion Date

March 22, 2021

Conditions
Relapsed/Refractory Multiple Myeloma
Interventions
DRUG

Daratumumab with dexamethasone

"Daratumumab:~Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (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 received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).~Dexamethasone:~Dexamethasone was administered at 40 mg (20 mg for patients \>75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle."

Trial Locations (1)

11528

"General Hospital of Athens Alexandra", Athens

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

lead

Hellenic Society of Hematology

OTHER