Multi-Center,Open-Label,Randomized,Phase 1B Study Evaluating Safety & Tolerability of Intravenous rhMBL in Pts With Multiple Myeloma Receiving Melphalan-Based High-Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplant
MBL deficient patients will be randomized in a ratio of 2:2:1 to receive up to 4 weekly i.v.
infusions of rhMBL at a dose of 0.5 mg/kg or 1.0 mg/kg, or standard anti-infectious
prophylactic therapy alone. A total of 20 patients will be treated in each of the rhMBL
arms, and 10 patients will receive best standard supportive prophylactic therapy but not
rhMBL. All patients are to receive anti-infectious prophylactic supportive therapy as per
institutional standards.
Major
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of rhMBL
2 months
Yes
Elias Anaissie, MD
Principal Investigator
University of Arkansas
United States: Food and Drug Administration
EZN-2232-01
NCT00388999
September 2006
May 2009
Name | Location |
---|---|
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |