Multiple Myeloma Clinical Trial
Official title:
S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders
RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with
monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma may
help doctors learn more about changes that occur in DNA and identify biomarkers related to
these diseases. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at blood and bone marrow samples from patients with
monoclonal gammopathy of undetermined significance, multiple myeloma, or plasmacytoma.
OBJECTIVES:
- Establish a serum, cell, and bone marrow tissue bank of prospectively collected samples
from patients with monoclonal gammopathy of undetermined significance (MGUS),
asymptomatic multiple myeloma, solitary plasmacytoma, or other plasma cell dyscrasias.
- Evaluate the feasibility of accruing patients with these diseases.
- Determine whether patterns of gene expression or cytogenetics exist that allow
molecular delineation of MGUS subtypes.
- Characterize cellular and humoral immune response to known tumor antigens in these
patients.
- Cryopreserve serum/T cells for future evaluation.
- Preliminarily identify biological correlates that may relate to progression to
symptomatic disease.
OUTLINE: Patients are stratified according to diagnosis (monoclonal gammopathy of
undetermined significance [MGUS] or other plasma cell dyscrasias vs asymptomatic multiple
myeloma vs solitary plasmacytoma).
Blood and bone marrow samples are collected and analyzed for microarray analysis,
cytogenetic analysis, and immunobiology studies.
Unused samples may be stored for future research studies.
Patients are followed periodically for 5 years.
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Observational Model: Cohort, Time Perspective: Prospective
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