S0120, Studying Blood and Bone Marrow Samples From Patients With Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, or Plasmacytoma
Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00900263
Collaborator
National Cancer Institute (NCI) (NIH)
375
69
5.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Actual Enrollment
:
375 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders
Study Start Date
:
Jun 1, 2002
Actual Primary Completion Date
:
Apr 1, 2016
Outcome Measures
Primary Outcome Measures
- Disease progression [5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Providence Cancer Center at Providence Hospital | Mobile | Alabama | United States | 36608 |
| 2 | Highlands Oncology Group - Springdale | Bentonville | Arkansas | United States | 72712 |
| 3 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 4 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90089-9181 |
| 5 | Veterans Affairs Medical Center - Hines | Hines | Illinois | United States | 60141 |
| 6 | Menorah Medical Center | Overland Park | Kansas | United States | 66209 |
| 7 | Saint Luke's Hospital - South | Overland Park | Kansas | United States | 66213 |
| 8 | Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | United States | 67401 |
| 9 | Shawnee Mission Medical Center | Shawnee Mission | Kansas | United States | 66204 |
| 10 | Cotton-O'Neil Cancer Center | Topeka | Kansas | United States | 66606 |
| 11 | Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | United States | 71315-3198 |
| 12 | Lahey Clinic Medical Center - Burlington | Burlington | Massachusetts | United States | 01805 |
| 13 | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 14 | Clemens Regional Medical Center | Mount Clemens | Michigan | United States | 48043 |
| 15 | University of Mississippi Cancer Clinic | Jackson | Mississippi | United States | 39216 |
| 16 | Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | United States | 64111 |
| 17 | St. Joseph Medical Center | Kansas City | Missouri | United States | 64114 |
| 18 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
| 19 | Parvin Radiation Oncology | Kansas City | Missouri | United States | 64116 |
| 20 | Heartland Hematology Oncology Associates, Incorporated | Kansas City | Missouri | United States | 64118 |
| 21 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 22 | Research Medical Center | Kansas City | Missouri | United States | 64132 |
| 23 | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | United States | 64086 |
| 24 | Liberty Hospital | Liberty | Missouri | United States | 64068 |
| 25 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
| 26 | Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri | United States | 64507 |
| 27 | Saint Louis University Cancer Center | Saint Louis | Missouri | United States | 63110 |
| 28 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 29 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
| 30 | St. Vincent Healthcare Cancer Care Services | Billings | Montana | United States | 59101 |
| 31 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59102 |
| 32 | Billings Clinic - Downtown | Billings | Montana | United States | 59107-7000 |
| 33 | Bozeman Deaconess Cancer Center | Bozeman | Montana | United States | 59715 |
| 34 | St. James Healthcare Cancer Care | Butte | Montana | United States | 59701 |
| 35 | Big Sky Oncology | Great Falls | Montana | United States | 59405-5309 |
| 36 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
| 37 | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | United States | 59405 |
| 38 | Northern Montana Hospital | Havre | Montana | United States | 59501 |
| 39 | St. Peter's Hospital | Helena | Montana | United States | 59601 |
| 40 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
| 41 | Kalispell Medical Oncology at KRMC | Kalispell | Montana | United States | 59901 |
| 42 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
| 43 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59807-7877 |
| 44 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59807 |
| 45 | Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska | United States | 68848-1990 |
| 46 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
| 47 | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | United States | 44307 |
| 48 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 49 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 50 | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 51 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234-6200 |
| 52 | Wilford Hall Medical Center | Lackland AFB | Texas | United States | 78236 |
| 53 | St. Joseph Cancer Center | Bellingham | Washington | United States | 98225 |
| 54 | Olympic Hematology and Oncology | Bremerton | Washington | United States | 98310 |
| 55 | Columbia Basin Hematology | Kennewick | Washington | United States | 99336 |
| 56 | Skagit Valley Hospital Cancer Care Center | Mt. Vernon | Washington | United States | 98273 |
| 57 | Harrison Poulsbo Hematology and Onocology | Poulsbo | Washington | United States | 98370 |
| 58 | Harborview Medical Center | Seattle | Washington | United States | 98104 |
| 59 | Minor and James Medical, PLLC | Seattle | Washington | United States | 98104 |
| 60 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
| 61 | Group Health Central Hospital | Seattle | Washington | United States | 98112 |
| 62 | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | United States | 98122-4307 |
| 63 | Polyclinic First Hill | Seattle | Washington | United States | 98122 |
| 64 | University Cancer Center at University of Washington Medical Center | Seattle | Washington | United States | 98195 |
| 65 | Cancer Care Northwest - Spokane South | Spokane | Washington | United States | 99202 |
| 66 | Evergreen Hematology and Oncology, PS | Spokane | Washington | United States | 99218 |
| 67 | Wenatchee Valley Medical Center | Wenatchee | Washington | United States | 98801-2028 |
| 68 | Rocky Mountain Oncology | Casper | Wyoming | United States | 82609 |
| 69 | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | United States | 82801 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Madhav Dhodapkar, MD, Rockefeller University
Study Documents (Full-Text)
None provided.More Information
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. 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. Epub 2006 Oct 5.
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00900263
Other Study ID Numbers:
- S0120
- S0120
- U10CA032102
First Posted:
May 12, 2009
Last Update Posted:
Oct 7, 2016
Last Verified:
Oct 1, 2016
Keywords provided by Southwest Oncology Group
Additional relevant MeSH terms: