• Safety and tolerability of rhMBL
  

• Pharmacokinetic (PK) of rhMBL
  
• Pharmacodynamics (PD) of rhMBL
  
• Immunogenicity of rhMBL, incidence of infectious complications
  

The study is evaluating 3 cohorts of patients receiving i.v. weekly rhMBL plus standard anti-infectious prophylaxis (2 cohorts) or anti-infectious prophylaxis alone (1 cohort). All patients are scheduled to receive melphalan-based high-dose chemotherapy followed by autologous HSCT.

All patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards. 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.

Major Inclusion Criteria: 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 Criteria:

• 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.