S0120, Studying Blood and Bone Marrow Samples From Patients With Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, or Plasmacytoma
|ClinicalTrials.gov Identifier: NCT00900263|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : October 7, 2016
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.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma Plasma Cell Myeloma Precancerous Condition||Genetic: cytogenetic analysis Genetic: microarray analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||375 participants|
|Official Title:||S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||April 2016|
- Disease progression [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900263
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|Study Chair:||Madhav Dhodapkar, MD||Rockefeller University|