S0120, Studying Blood and Bone Marrow Samples From Patients With Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, or Plasmacytoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders

Conditions
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Multiple Myeloma, Plasma Cell Myeloma, Precancerous Condition

Intervention / Treatment
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* Genetic: cytogenetic analysis
* Genetic: microarray analysis
* Other: biologic sample preservation procedure
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of one of the following plasmaproliferative diseases: Monoclonal gammopathy of undetermined significance (MGUS) Asymptomatic multiple myeloma Solitary plasmacytoma Other plasma cell dyscrasias Disease does not require therapy Willing to submit research samples for gene expression analysis and immunologic assessment PATIENT CHARACTERISTICS: Age Not specified Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No other malignancy within the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for this disease Chemotherapy No prior chemotherapy for this disease Endocrine therapy No prior endocrine therapy for this disease Radiotherapy No prior radiotherapy for this disease Surgery No prior surgery for this disease Other Prior or concurrent bisphosphonates allowed
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: cytogenetic analysis|nan|
|Genetic: microarray analysis|nan|
|Other: biologic sample preservation procedure|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I multiple myeloma, isolated plasmacytoma of bone, monoclonal gammopathy of undetermined significance