Safety & Efficacy Study High Dose Evomela Injection for MA Conditioning in MM Patients With Autologous Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

February 28, 2014

Study Completion Date

August 31, 2014

Conditions
Multiple Myeloma
Interventions
DRUG

High-Dose Melphalan HCL for Injection (Propylene Glycol-Free)

200 mg melphalan/m2 will be divided into two separate, consecutive doses of 100 mg/m2 administered on day -3 and day -2 prior to ASCT. The High-Dose Melphaln HCL for Injection (Propylene Glycol-Free) will be reconstituted to 5 mg/mL (also containing 270 mg/mL of Captisol®). The Melphalan HCL for Injection (Propylene Glycol Free) will be further diluted with normal saline to a concentration of no greater than 0.45 mg/mL and infused over 30 minutes ( + or - 3 minutes)via a central venous catheter.

OTHER

Autologous Transplantation

Patients who are myeloablative conditioning in multiple myeloma undergoing autologous transplantation( patients own blood-forming stem cells are collected to replace diseased bone marrow or bone marrow damaged by cancer treatment)

Trial Locations (6)

53226

Medical College of Wisconsin/Froedtert Hospital, Milwaukee

53792

University of Wisconsin Hospital and Clinics, Madison

60612

Rush University Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

66205

University of Kansas Medical Center, Fairway

01655

University of Massachusetts, Worcester

All Listed Sponsors
collaborator

Clinipace Worldwide

INDUSTRY

collaborator

Beckloff Associates, Inc.

INDUSTRY

collaborator

Kansas City Bioanalytical Laboratories

UNKNOWN

lead

Acrotech Biopharma Inc.

INDUSTRY