Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enzon Pharmaceuticals, Inc.
• Treatments: Lectins

Criteria

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.