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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00900263
Other study ID # S0120
Secondary ID S0120U10CA032102
Status Completed
Phase N/A
First received May 9, 2009
Last updated October 6, 2016
Start date June 2002

Study information

Verified date October 2016
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Genetic:
cytogenetic analysis

microarray analysis

Other:
biologic sample preservation procedure

laboratory biomarker analysis


Locations

Country Name City State
United States McDowell Cancer Center at Akron General Medical Center Akron Ohio
United States Tulane Cancer Center Office of Clinical Research Alexandria Louisiana
United States St. Joseph Cancer Center Bellingham Washington
United States Highlands Oncology Group - Springdale Bentonville Arkansas
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Olympic Hematology and Oncology Bremerton Washington
United States Lahey Clinic Medical Center - Burlington Burlington Massachusetts
United States St. James Healthcare Cancer Care Butte Montana
United States Rocky Mountain Oncology Casper Wyoming
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Big Sky Oncology Great Falls Montana
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Sletten Cancer Institute at Benefis Healthcare Great Falls Montana
United States Northern Montana Hospital Havre Montana
United States St. Peter's Hospital Helena Montana
United States Veterans Affairs Medical Center - Hines Hines Illinois
United States University of Mississippi Cancer Clinic Jackson Mississippi
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States CCOP - Kansas City Kansas City Missouri
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Parvin Radiation Oncology Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States St. Joseph Medical Center Kansas City Missouri
United States Good Samaritan Cancer Center at Good Samaritan Hospital Kearney Nebraska
United States Columbia Basin Hematology Kennewick Washington
United States Wilford Hall Medical Center Lackland AFB Texas
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Liberty Hospital Liberty Missouri
United States Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas
United States USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Providence Cancer Center at Providence Hospital Mobile Alabama
United States Clemens Regional Medical Center Mount Clemens Michigan
United States Skagit Valley Hospital Cancer Care Center Mt. Vernon Washington
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's Hospital - South Overland Park Kansas
United States Harrison Poulsbo Hematology and Onocology Poulsbo Washington
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Saint Joseph Oncology, Incorporated Saint Joseph Missouri
United States Saint Louis University Cancer Center Saint Louis Missouri
United States Tammy Walker Cancer Center at Salina Regional Health Center Salina Kansas
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Minor and James Medical, PLLC Seattle Washington
United States Polyclinic First Hill Seattle Washington
United States Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington
United States University Cancer Center at University of Washington Medical Center Seattle Washington
United States Shawnee Mission Medical Center Shawnee Mission Kansas
United States Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Evergreen Hematology and Oncology, PS Spokane Washington
United States Cotton-O'Neil Cancer Center Topeka Kansas
United States Wenatchee Valley Medical Center Wenatchee Washington

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2007 Mar 26. — View Citation

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. Epub 2006 Oct 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disease progression 5 years No
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