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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma

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 Summary:

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.


Sponsor: Southwest Oncology Group

Current Primary Outcome:

  • Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics [ Time Frame: 1 year ]
  • 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 ]
  • Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors [ Time Frame: 1 year ]
  • Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics [ Time Frame: 1 year ]


Original Primary Outcome:

  • 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


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Southwest Oncology Group

Dates:
Date Received: May 9, 2009
Date Started: September 2005
Date Completion:
Last Updated: March 5, 2015
Last Verified: March 2015