NCT Number: NCT00900263
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Providence Cancer Center at Providence Hospital, Mobile, Alabama, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
microarray analysis
Geneticbiologic sample preservation procedure
Otherlaboratory biomarker analysis
OtherPrimary outcomes
-
Disease progression
Time frame: 5 years
Sponsors and collaborators
Lead sponsor
SWOG Cancer Research Network
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders
Important dates
- Study start
- 2002
- Primary completion
- 2016
- First posted
- May 12, 2009
- Registry last updated
- Oct 7, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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