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

Completed

• Conditions: Lymphoma; Precancerous/Nonmalignant Condition; Multiple Myeloma and Plasma Cell Neoplasm

• Registration Number: NCT00898066
• Lead Sponsor: SWOG Cancer Research Network

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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics	1 year
Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors	1 year
Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics	1 year
Prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival	1 year