Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
NCT00388999 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2011-12-05
Summary
MBL deficient patients enrolled in this protocol are scheduled to be treated with melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0 mg/kg, or no rhMBL.
Conditions
Interventions
- DRUG
-
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
- DRUG
-
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
- DRUG
-
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg
Sponsors & Collaborators
-
Enzon Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Elias Anaissie, MD · University of Arkansas
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2009-02-28
- Completion
- 2009-05-31
Countries
- United States
Study Locations
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