S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders
N/A
N/A
Both
Multiple Myeloma, Plasma Cell Myeloma, Precancerous Condition
Trial Information
S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders
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.
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Disease progression
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Madhav Dhodapkar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Rockefeller University
Authority:
United States: Federal Government
Study ID:
CDR0000271421
NCT ID:
NCT00900263
Start Date:
June 2002
Completion Date:
Related Keywords:
- Multiple Myeloma
- Plasma Cell Myeloma
- Precancerous Condition
- stage I multiple myeloma
- isolated plasmacytoma of bone
- monoclonal gammopathy of undetermined significance
- Monoclonal Gammopathy of Undetermined Significance
- Paraproteinemias
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Precancerous Conditions
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| Big Sky Oncology | Great Falls, Montana 59405 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
| Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
| University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Polyclinic First Hill | Seattle, Washington 98122 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| Menorah Medical Center | Overland Park, Kansas 66209 |
| Saint Luke's Hospital - South | Overland Park, Kansas 66213 |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
| Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
| Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
| St. Joseph Medical Center | Kansas City, Missouri 64114 |
| Heartland Hematology Oncology Associates, Incorporated | Kansas City, Missouri 64118 |
| North Kansas City Hospital | Kansas City, Missouri 64116 |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
| Research Medical Center | Kansas City, Missouri 64132 |
| Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
| Liberty Hospital | Liberty, Missouri 64068 |
| Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
| Saint Joseph Oncology, Incorporated | Saint Joseph, Missouri 64507 |
| Billings Clinic - Downtown | Billings, Montana 59107-7000 |
| Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
| St. James Healthcare Cancer Care | Butte, Montana 59701 |
| 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 |
| Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Columbia Basin Hematology | Kennewick, Washington 99336 |
| Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
| Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Rocky Mountain Oncology | Casper, Wyoming 82609 |
| Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
| Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Highlands Oncology Group - Springdale | Springdale, Arkansas 72764 |
| St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
| Parvin Radiation Oncology | Kansas City, Missouri 64116 |
| Providence Cancer Center at Providence Hospital | Mobile, Alabama 36608 |
| Clemens Regional Medical Center | Mount Clemens, Michigan 48043 |
