PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function

PHASE2TerminatedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

August 28, 2018

Primary Completion Date

December 22, 2021

Study Completion Date

December 22, 2021

Conditions
Renal ImpairmentMultiple Myeloma
Interventions
DRUG

Melflufen

Melflufen was distributed in the European Union (EU) as a powder for concentrate for solution for infusion; in the US, it was distributed as a powder for injection. Melflufen was administered as a 30-minute intravenous infusion on Day 1 of every 28-day cycle via a central catheter.

DRUG

Dexamethasone

Tablets. Administered orally on Days 1, 8, 15, and 22 of each 28-day cycle. Dose of 40 mg for patients aged \<75 years. Dose of 20 mg for patients aged ≥75 years.

Trial Locations (10)

Unknown

University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology, Brno

University Hospital Olomouc, Clinic of Hemato-Oncology, Olomouc

General University Hospital in Prague, 1st Internal Clinic - Clinic of Hematology, Prague

"General Hospital of Athens Evangelismos", Athens

General Hospital of Athens Alexandra, Therapeutic Clinic, Athens

University General Hospital of Patras, Pátrai

Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka, Torun

Maria Sklodowska-Curie Institute of Oncology, Branch in Gliwice, Department of Bone Marrow Transplantation and Hematologic Oncology, Gliwice

Independent Public Healthcare Facility Municipal Hospitals, Department of Hematology, Katowice

Independent Public Teaching Hospital No.1 in Lublin, Department of Hematooncology, Bone Marrow Transplantation and Chemotherapy, Lublin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Oncopeptides AB

INDUSTRY