NCT00898040

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

May 9, 2009

Last Update Submit

May 17, 2017

Conditions

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (5)

  • 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

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

    1 month

  • SNPs associated with response

    1 month

  • SNPs associated with bone disease

    1 month

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

    1 month

Interventions

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Brian Van Ness

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

July 6, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

May 19, 2017

Record last verified: 2017-05