Status:
COMPLETED
Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
Lead Sponsor:
Enzon Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 mult...
Detailed Description
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 al...
Eligibility Criteria
Inclusion
- Major Patients must meet all of the following criteria to be eligible for enrollment into the study:
- Capable of understanding the protocol requirements and risks and providing written informed consent.
- Histologically or cytologically confirmed diagnosis of multiple myeloma.
- Mannose-binding lectin level \<300 ng/mL.
- Age ≥18 years old.
- Score of 0 to 2 on the Zubrod performance status scale.
- Patient is scheduled to receive melphalan-based high-dose chemotherapy and autologous HSCT for the treatment of multiple myeloma.
Exclusion
- Concurrent serious medical illness that could potentially interfere with protocol compliance.
- Concurrent or previous malignancy associated with a poor prognosis.
- Known chronic infectious disease, such as acquired immunodeficiency syndrome (AIDS) or hepatitis (for hepatitis and human immunodeficiency virus \[HIV\] will not be performed).
- Positive screening pregnancy test or is breast-feeding.
- Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
- Known or clinically suspected active brain metastases.
- Current participation in another clinical study with an investigational agent and/or use of an investigational drug.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00388999
Start Date
September 1 2006
End Date
May 1 2009
Last Update
December 5 2011
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205