Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant
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
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Sep 2006
Shorter than P25 for phase_1 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 13, 2006
CompletedFirst Posted
Study publicly available on registry
October 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedDecember 5, 2011
December 1, 2011
2.4 years
October 13, 2006
December 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of rhMBL
2 months
Secondary Outcomes (3)
Pharmacokinetic (PK) of rhMBL
2 months
Pharmacodynamics (PD) of rhMBL
2 months
Immunogenicity of rhMBL, incidence of infectious complications
2 months
Study Arms (3)
0 mg/kg
OTHER0.5 mg/kg
OTHER1.0 mg/kg
OTHERInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elias Anaissie, MD
University of Arkansas
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 13, 2006
First Posted
October 17, 2006
Study Start
September 1, 2006
Primary Completion
February 1, 2009
Study Completion
May 1, 2009
Last Updated
December 5, 2011
Record last verified: 2011-12