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

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ClinicalTrials.gov Identifier: NCT00900263
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : October 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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
Multiple Myeloma Plasma Cell Myeloma Precancerous Condition Genetic: cytogenetic analysis Genetic: microarray analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis

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 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 : June 2002
Actual Primary Completion Date : April 2016





Primary Outcome Measures :
  1. Disease progression [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Bone marrow/peripheral blood


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
plasmaproliferative disease not requiring therapy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900263


  Show 69 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Madhav Dhodapkar, MD Rockefeller University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00900263     History of Changes
Other Study ID Numbers: S0120
S0120 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016

Keywords provided by Southwest Oncology Group:
stage I multiple myeloma
isolated plasmacytoma of bone
monoclonal gammopathy of undetermined significance

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Precancerous Conditions
Plasmacytoma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia