This trial is active, not recruiting.

Conditions multiple myeloma, plasma cell myeloma, precancerous condition
Treatments cytogenetic analysis, microarray analysis, biologic sample preservation procedure, laboratory biomarker analysis
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date June 2002
End date April 2016
Trial size 350 participants
Trial identifier NCT00900263, S0120, U10CA032102


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Disease progression
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.