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Multiple MyelomaNCT00900263

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

An observational study of Multiple Myeloma and Plasma Cell Myeloma, run by SWOG Cancer Research Network at 69 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
cytogenetic analysis, microarray analysis and biologic sample preservation procedure
How many people
375 participants
Where
69 sitesUnited States
Study dates
Jun 2002to Apr 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: plasmaproliferative disease not requiring therapy

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

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

United States69 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana, 71315-3198

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Highlands Oncology Group - Springdale

    Bentonville, Arkansas, 72712

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Northern Montana Hospital

    Havre, Montana, 59501

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • Heartland Hematology Oncology Associates, Incorporated

    Kansas City, Missouri, 64118

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • Clemens Regional Medical Center

    Mount Clemens, Michigan, 48043

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's Hospital - South

    Overland Park, Kansas, 66213

  • Harrison Poulsbo Hematology and Onocology

    Poulsbo, Washington, 98370

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology, Incorporated

    Saint Joseph, Missouri, 64507

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology, PS

    Spokane, Washington, 99218

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
cytogenetic analysis, microarray analysis, biologic sample preservation procedure, laboratory biomarker analysis
Keywords
stage I multiple myeloma, isolated plasmacytoma of bone, monoclonal gammopathy of undetermined significance
Medical subject headings
Multiple Myeloma, Precancerous Conditions, Monoclonal Gammopathy of Undetermined Significance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cytogenetic analysisGenetic

  • microarray analysisGenetic

  • biologic sample preservation procedureOther

  • laboratory biomarker analysisOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease progression

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2009 (estimated)
  2. Study startJun 2002
  3. Primary completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00900263
Sponsor's protocol ID
S0120
Other IDs
S0120, U10CA032102
Status last verified
Oct 2016
First submitted
9 May 2009
Last updated
7 Oct 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 17389240

  • 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.

    PubMed 17023574

  • 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.

    PubMed 32816893

  • 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.

    PubMed 26468228

  • 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.

    PubMed 24144643

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma and Plasma Cell Myeloma, run by SWOG Cancer Research Network at 69 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease progression (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00900263, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.

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