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

NCT ID: NCT00388999

Last Updated: 2011-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Multiple Myeloma

Keywords

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Multiple Myeloma Stem Cell Transplant rhMBL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0 mg/kg

Group Type OTHER

Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

Intervention Type DRUG

Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

0.5 mg/kg

Group Type OTHER

Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

Intervention Type DRUG

Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

1.0 mg/kg

Group Type OTHER

Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

Intervention Type DRUG

Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

Interventions

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Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

Intervention Type DRUG

Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

Intervention Type DRUG

Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)

Intravenous (i.v.) administration for 4 weeks. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enzon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Enzon Pharmaceuticals, Inc

Principal Investigators

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Elias Anaissie, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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EZN-2232-01

Identifier Type: -

Identifier Source: org_study_id