S0120, Studying Blood and Bone Marrow Samples From Patients With Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, or Plasmacytoma
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.
Plasma Cell Myeloma
Genetic: cytogenetic analysis
Genetic: microarray analysis
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders|
- Disease progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Bone marrow/peripheral blood
|Study Start Date:||June 2002|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900263
Show 69 Study Locations
|Study Chair:||Madhav Dhodapkar, MD||Rockefeller University|