Study of DNA Samples From Patients With Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

Proposal for Combining ECOG Myeloma Trial SNP Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898040
• Other study ID #: CDR0000495284
• Secondary ID: ECOG-E3L06T1
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 17, 2017
• Start date: July 6, 2006
• Est. completion date: January 1, 2007

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 1, 2007
• Est. primary completion date: January 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Genetic:
• polymorphism analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 month
Primary	SNPs associated with toxicities caused by individual genetic variations affecting drug activation, distribution, metabolism, and export (ADME)		1 month
Primary	SNPs associated with response		1 month
Primary	SNPs associated with bone disease		1 month
Primary	SNPs associated with epidemiology (i.e., risk factors for the development of multiple myeloma)		1 month