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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00900263
Enrollment
375
Registered
2009-05-12
Start date
2002-06-30
Completion date
Unknown
Last updated
2016-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Plasma Cell Myeloma, Precancerous Condition

Keywords

stage I multiple myeloma, isolated plasmacytoma of bone, monoclonal gammopathy of undetermined significance

Brief 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.

Interventions

GENETICcytogenetic analysis
GENETICmicroarray analysis
OTHERbiologic sample preservation procedure
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Disease progression5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026