Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Stem Cell Transplant, rhMBL
Eligibility 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.
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
0 mg/kg
0.5 mg/kg
1.0 mg/kg
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability of rhMBL
Secondary Outcome Measures
Pharmacokinetic (PK) of rhMBL
Pharmacodynamics (PD) of rhMBL
Immunogenicity of rhMBL, incidence of infectious complications
Full Information
NCT ID
NCT00388999
First Posted
October 13, 2006
Last Updated
December 2, 2011
Sponsor
Enzon Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00388999
Brief Title
Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Enzon Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Stem Cell Transplant, rhMBL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0 mg/kg
Arm Type
Other
Arm Title
0.5 mg/kg
Arm Type
Other
Arm Title
1.0 mg/kg
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Intervention Description
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
Intervention Name(s)
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Intervention Description
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
Intervention Name(s)
Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL)
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and tolerability of rhMBL
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) of rhMBL
Time Frame
2 months
Title
Pharmacodynamics (PD) of rhMBL
Time Frame
2 months
Title
Immunogenicity of rhMBL, incidence of infectious complications
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias Anaissie, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
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