NCT00898066

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

May 9, 2009

Last Update Submit

March 5, 2015

Conditions

LymphomaMultiple Myeloma and Plasma Cell NeoplasmPrecancerous/Nonmalignant Condition

Keywords

Waldenstrom macroglobulinemiamonoclonal gammopathy of undetermined significanceprimary systemic amyloidosisstage I multiple myelomastage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (4)

  • Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics

    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

  • 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

Interventions

cytogenetic analysisGENETIC

marrow and peripheral blood

fluorescence in situ hybridizationGENETIC

marrow and peripheral blood

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaMultiple MyelomaNeoplasms, Plasma CellPrecancerous ConditionsWaldenstrom MacroglobulinemiaMonoclonal Gammopathy of Undetermined SignificanceImmunoglobulin Light-chain Amyloidosis

Interventions

Cytogenetic AnalysisIn Situ Hybridization, Fluorescence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersHypergammaglobulinemiaAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesHistological TechniquesNucleic Acid Hybridization

Study Officials

  • Diane L. Persons, MD

    University of Kansas

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

September 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 6, 2015

Record last verified: 2015-03