Multiple Myeloma and Plasma Cell NeoplasmNCT00898040
Study of DNA Samples From Patients With Multiple Myeloma
An observational study of Multiple Myeloma and Plasma Cell Neoplasm, run by ECOG-ACRIN Cancer Research Group.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- polymorphism analysis
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2006to 1 Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: Proposal for Combining ECOG Myeloma Trial SNP Data
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.
Read the 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.
- Being tested
- polymorphism analysis
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymorphism analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
SNPs associated with toxicities caused by individual genetic variations affecting drug activation, distribution, metabolism, and export (ADME)
Measured: 1 month
SNPs associated with response
Measured: 1 month
SNPs associated with bone disease
Measured: 1 month
SNPs associated with epidemiology (i.e., risk factors for the development of multiple myeloma)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start6 Jul 2006
- Primary completion1 Jan 2007
- Study completion1 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian Van Ness, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898040
- Sponsor's protocol ID
- CDR0000495284
- Other IDs
- ECOG-E3L06T1
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for Combining ECOG Myeloma Trial SNP Data
- ClinicalTrials.gov ID
- NCT00898040
- Acronym / sponsor ID
- CDR0000495284
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jul 2006 (actual)
- Primary completion
- 1 Jan 2007 (actual)
- Study completion
- 1 Jan 2007 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polymorphism analysis | Genetic | – |
Primary outcome
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
SNPs associated with toxicities caused by individual genetic variations affecting drug activation, distribution, metabolism, and export (ADME)
Time frame: 1 month
SNPs associated with response
Time frame: 1 month
SNPs associated with bone disease
Time frame: 1 month
SNPs associated with epidemiology (i.e., risk factors for the development of multiple myeloma)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Van Ness study chair
Masonic Cancer Center, University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Plasma Cell Neoplasm, run by ECOG-ACRIN Cancer Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.