Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
This study has been completed.
Sponsor:
Enzon Pharmaceuticals, Inc.
Information provided by:
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00388999
First received: October 13, 2006
Last updated: December 2, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Enzon Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Safety and tolerability of rhMBL [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic (PK) of rhMBL [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Pharmacodynamics (PD) of rhMBL [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Immunogenicity of rhMBL, incidence of infectious complications [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 46 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 0 mg/kg |
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
|
| 0.5 mg/kg |
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
|
| 1.0 mg/kg |
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388999
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
Sponsors and Collaborators
Enzon Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Elias Anaissie, MD | University of Arkansas |
More Information
No publications provided
| Responsible Party: | Nazish Huq, Clinical Project Manager, Enzon Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00388999 History of Changes |
| Other Study ID Numbers: | EZN-2232-01 |
| Study First Received: | October 13, 2006 |
| Last Updated: | December 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Enzon Pharmaceuticals, Inc.:
|
Multiple Myeloma Stem Cell Transplant rhMBL |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013