NCT00900263

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 375 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Multiple Myeloma
• Plasma Cell Myeloma
• Precancerous Condition

Interventions

Type	Name	Description
GENETIC	cytogenetic analysis
GENETIC	microarray analysis
OTHER	biologic sample preservation procedure
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2002-06-01
• Primary completion: 2016-04-01
• First posted: 2009-05-12
• Last updated: 2016-10-07

Locations

69 sites across 1 country: United States