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

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00388999

Run by

Enzon Pharmaceuticals, Inc.

People needed

46

Starts

2006-09-01

Expected to finish

2009-05-01

Last updated by the study team

2011-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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