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

SWOG Cancer Research Network

Status: Completed

Conditions: Plasma Cell Myeloma; Multiple Myeloma; Precancerous Condition

Treatments: Other: laboratory biomarker analysis; Other: biologic sample preservation procedure; Genetic: microarray analysis; Genetic: cytogenetic analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00900263

S0120 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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