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

This study has been completed.
Sponsor:
Information provided by:
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00388999
First received: October 13, 2006
Last updated: December 2, 2011
Last verified: December 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014