Clinical trial NCT00898066: S0334 Analyzing Chromosomes in Patients With Newly Diagnosed Multiple Myeloma or Other Blood Disease
Official title: Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous/Nonmalignant Condition
Keywords: Waldenstrom macroglobulinemia
monoclonal gammopathy of undetermined significance
primary systemic amyloidosis
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
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

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.

Eligibility 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

Primary outcomes:
measure: Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics
timeFrame: 1 year
measure: Prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival
timeFrame: 1 year
measure: Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors
timeFrame: 1 year
measure: Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas
name: Diane L. Persons, MD
role: STUDY_CHAIR
References: