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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 )

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.


Condition or disease Intervention/treatment
Multiple Myeloma and Plasma Cell Neoplasm Genetic: polymorphism analysis

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
Actual Enrollment : 600 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Proposal for Combining ECOG Myeloma Trial SNP Data
Actual Study Start Date : July 6, 2006
Actual Primary Completion Date : January 1, 2007
Actual Study Completion Date : January 1, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898040


Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: Brian Van Ness Masonic Cancer Center, University of Minnesota

Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00898040     History of Changes
Other Study ID Numbers: CDR0000495284
ECOG-E3L06T1
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases