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S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders


N/A
N/A
N/A
Open (Enrolling)
Both
Multiple Myeloma, Plasma Cell Myeloma, Precancerous Condition

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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 CenterSeattle, Washington  98109
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Lahey Clinic Medical Center - BurlingtonBurlington, Massachusetts  01805
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
St. Joseph Medical CenterKansas City, Missouri  64114
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Harrison Poulsbo Hematology and OnocologyPoulsbo, Washington  98370
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Parvin Radiation OncologyKansas City, Missouri  64116
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Clemens Regional Medical CenterMount Clemens, Michigan  48043