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Completed

NCT Number: NCT00898040

Study of DNA Samples From Patients With Multiple Myeloma

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.

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Key information

Conditions

Multiple Myeloma and Plasma Cell Neoplasm Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polymorphism analysis

Genetic

Primary outcomes

  1. 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

  2. SNPs associated with toxicities caused by individual genetic variations affecting drug activation, distribution, metabolism, and export (ADME)

    Time frame: 1 month

  3. SNPs associated with response

    Time frame: 1 month

  4. SNPs associated with bone disease

    Time frame: 1 month

  5. SNPs associated with epidemiology (i.e., risk factors for the development of multiple myeloma)

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Proposal for Combining ECOG Myeloma Trial SNP Data

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 12, 2009
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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