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

Lymphoma Clinical Trial

Official title:

Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898066
• Other study ID #: S0334
• Secondary ID: U10CA032102S0334
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: March 5, 2015
• Start date: September 2005
• Est. completion date: June 2007

Study information

• Verified date: March 2015
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precancerous Conditions
• Precancerous/Nonmalignant Condition

Intervention

Genetic:
• cytogenetic analysis
marrow and peripheral blood
• fluorescence in situ hybridization
marrow and peripheral blood

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics		1 year	No
Primary	Prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival		1 year	No
Primary	Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors		1 year	No
Primary	Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics		1 year	No