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