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S0334 Analyzing Chromosomes in Patients With Newly Diagnosed Multiple Myeloma or Other Blood Disease

Primary Purpose

Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
cytogenetic analysis
fluorescence in situ hybridization
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lymphoma focused on measuring Waldenstrom macroglobulinemia, monoclonal gammopathy of undetermined significance, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Multiple myeloma (MM)
    • Smoldering myeloma
    • Waldenstrom's macroglobulinemia (WM)
    • Monoclonal gammopathy of undetermined significance (MGUS)
    • Amyloidosis (AL)
  • Newly diagnosed disease

  • Must be currently registered, but have not begun therapy, on 1 of the following Southwest Oncology Group (SWOG) treatment clinical trials:

    • SWOG-S0115
    • SWOG-S0232
    • SWOG-S0340
    • All new SWOG coordinated MM, smoldering myeloma, WM, MGUS, or AL clinical trials activated on or after the activation date of this research study (SWOG-S0334)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics
    Prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival
    Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors
    Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics

    Secondary Outcome Measures

    Full Information

    First Posted
    May 9, 2009
    Last Updated
    March 5, 2015
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00898066
    Brief Title
    S0334 Analyzing Chromosomes in Patients With Newly Diagnosed Multiple Myeloma or Other Blood Disease
    Official Title
    Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    June 2007 (Actual)
    Study Completion Date
    June 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    RATIONALE: Studying the chromosomes in samples of bone marrow and blood in the laboratory from patients with cancer or other blood diseases may help doctors learn more about the disease. PURPOSE: This laboratory study is analyzing chromosomes in patients with newly diagnosed multiple myeloma or other blood disease.
    Detailed Description
    OBJECTIVES: Compare the frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics in patients with newly diagnosed multiple myeloma (MM) or other monoclonal gammopathies (MG). Examine the prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival in these patients. Compare the prognostic value of cytogenetics and FISH with other MM and MG prognostic factors in these patients. Correlate the presence of cytogenetic and FISH features with clinical pathophysiological, cellular, or other molecular characteristics in these patients. OUTLINE: Patients receive treatment as directed by the treatment clinical trial on which they are registered. Patients undergo bone marrow or blood sample collection periodically for conventional cytogenetic analysis and fluorescence in situ hybridization studies (FISH). Samples are analyzed for deleted 13q/monosomy 13 and chromosomal abnormalities. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition
    Keywords
    Waldenstrom macroglobulinemia, monoclonal gammopathy of undetermined significance, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

    7. Study Design

    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    cytogenetic analysis
    Intervention Description
    marrow and peripheral blood
    Intervention Type
    Genetic
    Intervention Name(s)
    fluorescence in situ hybridization
    Intervention Description
    marrow and peripheral blood
    Primary Outcome Measure Information:
    Title
    Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics
    Time Frame
    1 year
    Title
    Prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival
    Time Frame
    1 year
    Title
    Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors
    Time Frame
    1 year
    Title
    Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Multiple myeloma (MM) Smoldering myeloma Waldenstrom's macroglobulinemia (WM) Monoclonal gammopathy of undetermined significance (MGUS) Amyloidosis (AL) Newly diagnosed disease Must be currently registered, but have not begun therapy, on 1 of the following Southwest Oncology Group (SWOG) treatment clinical trials: SWOG-S0115 SWOG-S0232 SWOG-S0340 All new SWOG coordinated MM, smoldering myeloma, WM, MGUS, or AL clinical trials activated on or after the activation date of this research study (SWOG-S0334) PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics
    Study Population Description
    pts from S0115, S0232, S0340, S0417 and all new SWOG MM SM, WM, MGUS studies after 9/1/05 before closure
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diane L. Persons, MD
    Organizational Affiliation
    University of Kansas
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    S0334 Analyzing Chromosomes in Patients With Newly Diagnosed Multiple Myeloma or Other Blood Disease

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