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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma; Plasma Cell Myeloma; Precancerous Condition
• Intervention / Treatment: Other: biologic sample preservation procedure; Other: laboratory biomarker analysis; Genetic: cytogenetic analysis; Genetic: microarray analysis

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.

• Study Type: Observational
• Enrollment (Actual): 375

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Providence Cancer Center at Providence Hospital
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Highlands Oncology Group - Springdale
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • California
    • Los Angeles, California, United States, 90089-9181
      • USC/Norris Comprehensive Cancer Center and Hospital
  • Illinois
    • Hines, Illinois, United States, 60141
      • Veterans Affairs Medical Center - Hines
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Menorah Medical Center
    • Overland Park, Kansas, United States, 66213
      • Saint Luke's Hospital - South
    • Salina, Kansas, United States, 67401
      • Tammy Walker Cancer Center at Salina Regional Health Center
    • Shawnee Mission, Kansas, United States, 66204
      • Shawnee Mission Medical Center
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Cancer Center
  • Louisiana
    • Alexandria, Louisiana, United States, 71315-3198
      • Tulane Cancer Center Office of Clinical Research
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center - Burlington
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Josephine Ford Cancer Center at Henry Ford Hospital
    • Mount Clemens, Michigan, United States, 48043
      • Clemens Regional Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Cancer Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • Kansas City, Missouri, United States, 64116
      • North Kansas City Hospital
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Cancer Institute at Saint Luke's Hospital
    • Kansas City, Missouri, United States, 64114
      • St. Joseph Medical Center
    • Kansas City, Missouri, United States, 64116
      • Parvin Radiation Oncology
    • Kansas City, Missouri, United States, 64118
      • Heartland Hematology Oncology Associates, Incorporated
    • Lee's Summit, Missouri, United States, 64086
      • Saint Luke's East - Lee's Summit
    • Liberty, Missouri, United States, 64068
      • Liberty Hospital
    • Saint Joseph, Missouri, United States, 64506
      • Heartland Regional Medical Center
    • Saint Joseph, Missouri, United States, 64507
      • Saint Joseph Oncology, Incorporated
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University Cancer Center
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
    • Billings, Montana, United States, 59101
      • Northern Rockies Radiation Oncology Center
    • Billings, Montana, United States, 59101
      • St. Vincent Healthcare Cancer Care Services
    • Billings, Montana, United States, 59107-7000
      • Billings Clinic - Downtown
    • Billings, Montana, United States, 59102
      • Hematology-Oncology Centers of the Northern Rockies - Billings
    • Bozeman, Montana, United States, 59715
      • Bozeman Deaconess Cancer Center
    • Butte, Montana, United States, 59701
      • St. James Healthcare Cancer Care
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic - Main Facility
    • Great Falls, Montana, United States, 59405-5309
      • Big Sky Oncology
    • Great Falls, Montana, United States, 59405
      • Sletten Cancer Institute at Benefis Healthcare
    • Havre, Montana, United States, 59501
      • Northern Montana Hospital
    • Helena, Montana, United States, 59601
      • St. Peter's Hospital
    • Kalispell, Montana, United States, 59901
      • Kalispell Regional Medical Center
    • Kalispell, Montana, United States, 59901
      • Glacier Oncology, PLLC
    • Kalispell, Montana, United States, 59901
      • Kalispell Medical Oncology at KRMC
    • Missoula, Montana, United States, 59807-7877
      • Montana Cancer Specialists at Montana Cancer Center
    • Missoula, Montana, United States, 59807
      • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Nebraska
    • Kearney, Nebraska, United States, 68848-1990
      • Good Samaritan Cancer Center at Good Samaritan Hospital
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital, Incorporated
  • Ohio
    • Akron, Ohio, United States, 44307
      • McDowell Cancer Center at Akron General Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • CCOP - Upstate Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • Texas
    • Fort Sam Houston, Texas, United States, 78234-6200
      • Brooke Army Medical Center
    • Lackland AFB, Texas, United States, 78236
      • Wilford Hall Medical Center
  • Washington
    • Bellingham, Washington, United States, 98225
      • St. Joseph Cancer Center
    • Bremerton, Washington, United States, 98310
      • Olympic Hematology and Oncology
    • Kennewick, Washington, United States, 99336
      • Columbia Basin Hematology
    • Mt. Vernon, Washington, United States, 98273
      • Skagit Valley Hospital Cancer Care Center
    • Poulsbo, Washington, United States, 98370
      • Harrison Poulsbo Hematology and Onocology
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98104
      • Minor and James Medical, PLLC
    • Seattle, Washington, United States, 98112
      • Group Health Central Hospital
    • Seattle, Washington, United States, 98122-4307
      • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
    • Seattle, Washington, United States, 98122
      • Polyclinic First Hill
    • Seattle, Washington, United States, 98195
      • University Cancer Center at University of Washington Medical Center
    • Spokane, Washington, United States, 99202
      • Cancer Care Northwest - Spokane South
    • Spokane, Washington, United States, 99218
      • Evergreen Hematology and Oncology, PS
    • Wenatchee, Washington, United States, 98801-2028
      • Wenatchee Valley Medical Center
  • Wyoming
    • Casper, Wyoming, United States, 82609
      • Rocky Mountain Oncology
    • Sheridan, Wyoming, United States, 82801
      • Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

plasmaproliferative disease not requiring therapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease progression	5 years

Collaborators and Investigators

• Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Madhav Dhodapkar, MD, Rockefeller University

Publications and helpful links

General Publications

• Spisek R, Kukreja A, Chen LC, Matthews P, Mazumder A, Vesole D, Jagannath S, Zebroski HA, Simpson AJ, Ritter G, Durie B, Crowley J, Shaughnessy JD Jr, Scanlan MJ, Gure AO, Barlogie B, Dhodapkar MV. Frequent and specific immunity to the embryonal stem cell-associated antigen SOX2 in patients with monoclonal gammopathy. J Exp Med. 2007 Apr 16;204(4):831-40. doi: 10.1084/jem.20062387. Epub 2007 Mar 26.
• Zhan F, Barlogie B, Arzoumanian V, Huang Y, Williams DR, Hollmig K, Pineda-Roman M, Tricot G, van Rhee F, Zangari M, Dhodapkar M, Shaughnessy JD Jr. Gene-expression signature of benign monoclonal gammopathy evident in multiple myeloma is linked to good prognosis. Blood. 2007 Feb 15;109(4):1692-700. doi: 10.1182/blood-2006-07-037077. Epub 2006 Oct 5.
• Dhodapkar MV, Sexton R, Hoering A, Van Rhee F, Barlogie B, Orlowski R. Race-Dependent Differences in Risk, Genomics, and Epstein-Barr Virus Exposure in Monoclonal Gammopathies: Results of SWOG S0120. Clin Cancer Res. 2020 Nov 15;26(22):5814-5819. doi: 10.1158/1078-0432.CCR-20-2119. Epub 2020 Aug 18.
• Dhodapkar MV, Sexton R, Das R, Dhodapkar KM, Zhang L, Sundaram R, Soni S, Crowley JJ, Orlowski RZ, Barlogie B. Prospective analysis of antigen-specific immunity, stem-cell antigens, and immune checkpoints in monoclonal gammopathy. Blood. 2015 Nov 26;126(22):2475-8. doi: 10.1182/blood-2015-03-632919. Epub 2015 Oct 14.
• Dhodapkar MV, Sexton R, Waheed S, Usmani S, Papanikolaou X, Nair B, Petty N, Shaughnessy JD Jr, Hoering A, Crowley J, Orlowski RZ, Barlogie B. Clinical, genomic, and imaging predictors of myeloma progression from asymptomatic monoclonal gammopathies (SWOG S0120). Blood. 2014 Jan 2;123(1):78-85. doi: 10.1182/blood-2013-07-515239. Epub 2013 Oct 21.

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: stage I multiple myeloma; monoclonal gammopathy of undetermined significance; isolated plasmacytoma of bone
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Protein Disorders; Hypergammaglobulinemia; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Precancerous Conditions; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
• Other Study ID Numbers: S0120 (Other Identifier: SWOG); U10CA032102 (U.S. NIH Grant/Contract)