Clinical Trial: Study of DNA Samples From Patients With Multiple Myeloma
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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 Summary:
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.
Sponsor: ECOG-ACRIN Cancer Research Group
Current Primary Outcome:
- 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:
- 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)
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Eastern Cooperative Oncology Group
Dates:
Date Received: May 9, 2009
Date Started: July 6, 2006
Date Completion:
Last Updated: May 17, 2017
Last Verified: May 2017