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NCT Number: NCT00898066

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cytogenetic analysis

Genetic

marrow and peripheral blood

fluorescence in situ hybridization

Genetic

marrow and peripheral blood

Primary outcomes

  1. Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics

    Time frame: 1 year

  2. 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

  3. Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors

    Time frame: 1 year

  4. Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 12, 2009
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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