Text Size

Study of DNA Samples From Patients With Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898040
First received: May 9, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention
Multiple Myeloma and Plasma Cell Neoplasm
 Genetic: polymorphism analysis

Study Type: Observational
Official Title: Proposal for Combining ECOG Myeloma Trial SNP Data

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • SNPs associated with toxicities caused by individual genetic variations affecting drug activation, distribution, metabolism, and export (ADME) [ Designated as safety issue: No ]
  • SNPs associated with response [ Designated as safety issue: No ]
  • SNPs associated with bone disease [ Designated as safety issue: No ]
  • SNPs associated with epidemiology (i.e., risk factors for the development of multiple myeloma) [ Designated as safety issue: No ]

Estimated Enrollment: 600
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898040

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Brian Van Ness Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00898040     History of Changes
Other Study ID Numbers: CDR0000495284, ECOG-E3L06T1
Study First Received: May 9, 2009
Last Updated: May 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

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

ClinicalTrials.gov processed this record on May 23, 2013