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Study of DNA Samples From Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00898040
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date May 19, 2017
Actual Study Start Date July 6, 2006
Actual Primary Completion Date January 1, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2017)
  • Increased frequency of ≥1 polymorphic alleles associated with clinical endpoints using custom myeloma SNP chip analysis of banked DNA samples from patients with multiple myeloma [ Time Frame: 1 month ]
  • SNPs associated with toxicities caused by individual genetic variations affecting drug activation, distribution, metabolism, and export (ADME) [ Time Frame: 1 month ]
  • SNPs associated with response [ Time Frame: 1 month ]
  • SNPs associated with bone disease [ Time Frame: 1 month ]
  • SNPs associated with epidemiology (i.e., risk factors for the development of multiple myeloma) [ Time Frame: 1 month ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
  • Increased frequency of ≥1 polymorphic alleles associated with clinical endpoints using custom myeloma SNP chip analysis of banked DNA samples from patients with multiple myeloma
  • SNPs associated with toxicities caused by individual genetic variations affecting drug activation, distribution, metabolism, and export (ADME)
  • SNPs associated with response
  • SNPs associated with bone disease
  • SNPs associated with epidemiology (i.e., risk factors for the development of multiple myeloma)
Change History Complete list of historical versions of study NCT00898040 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of DNA Samples From Patients With Multiple Myeloma
Official Title Proposal for Combining ECOG Myeloma Trial SNP Data
Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at DNA samples from patients with multiple myeloma.

Detailed Description

OBJECTIVES:

  • Determine whether there is an increased frequency of 1 or more polymorphic alleles that are associated with clinical endpoints using custom myeloma single nucleotide polymorphism (SNP) chip analysis of banked DNA samples from patients with multiple myeloma.
  • Determine SNPs associated with toxicities caused, not by variations in tumor cell genetics, but by individual genetic variations affecting drug activation, distribution, metabolism, and export (ADME).
  • Determine SNPs associated with response, influenced by the same ADME.
  • Determine SNPs associated with bone disease (as a variable) among patients with multiple myeloma.
  • Determine SNPs associated with epidemiology (i.e., risk factors for the development of multiple myeloma).

OUTLINE: This is a retrospective, multicenter study.

Banked DNA samples are analyzed using a custom single nucleotide polymorphism (SNP) chip to assess approximately 3,590 SNPs from 1,061 genes that are associated with myeloma growth and response.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Multiple Myeloma and Plasma Cell Neoplasm
Intervention Genetic: polymorphism analysis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 9, 2009)
600
Original Estimated Enrollment Same as current
Actual Study Completion Date January 1, 2007
Actual Primary Completion Date January 1, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma
  • DNA samples banked from other ECOG studies (and other clinical trial groups [e.g., SWOG and MRC])

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00898040
Other Study ID Numbers CDR0000495284
ECOG-E3L06T1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
Study Sponsor ECOG-ACRIN Cancer Research Group
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Brian Van Ness Masonic Cancer Center, University of Minnesota
PRS Account Eastern Cooperative Oncology Group
Verification Date May 2017