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

Multiple Myeloma Clinical Trial

Official title:

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

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. 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

• Monoclonal Gammopathy of Undetermined Significance
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Plasma Cell Myeloma
• Plasmacytoma
• Precancerous Condition
• Precancerous Conditions

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