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

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.