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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00898066
First received: May 9, 2009
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous/Nonmalignant Condition
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization

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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: September 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: cytogenetic analysis
    marrow and peripheral blood
    Genetic: fluorescence in situ hybridization
    marrow and peripheral blood
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898066

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Diane L. Persons, MD University of Kansas
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00898066     History of Changes
Other Study ID Numbers: CDR0000442394, U10CA032102, S0334
Study First Received: May 9, 2009
Last Updated: October 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
Waldenstrom macroglobulinemia
monoclonal gammopathy of undetermined significance
primary systemic amyloidosis
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014