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

March 5, 2015 updated by: Southwest Oncology Group

Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pts from S0115, S0232, S0340, S0417 and all new SWOG MM SM, WM, MGUS studies after 9/1/05 before closure

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Diane L. Persons, MD, University of Kansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria