LymphomaNCT00898066
S0334 Analyzing Chromosomes in Patients With Newly Diagnosed Multiple Myeloma or Other Blood Disease
An observational study of Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Studying the chromosomes in samples of bone marrow and blood in the laboratory from patients with cancer or other blood diseases may help doctors learn more about the disease. PURPOSE: This laboratory study is analyzing chromosomes in patients with newly diagnosed multiple myeloma or other blood disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous/Nonmalignant Condition
- What is being tested?
- cytogenetic analysis and fluorescence in situ hybridization
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pts from S0115, S0232, S0340, S0417 and all new SWOG MM SM, WM, MGUS studies after 9/1/05 before closure
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Multiple myeloma (MM)
- Smoldering myeloma
- Waldenstrom's macroglobulinemia (WM)
- Monoclonal gammopathy of undetermined significance (MGUS)
- Amyloidosis (AL)
- Newly diagnosed disease
- Must be currently registered, but have not begun therapy, on 1 of the following Southwest Oncology Group (SWOG) treatment clinical trials:
- SWOG-S0115
- SWOG-S0232
- SWOG-S0340
- All new SWOG coordinated MM, smoldering myeloma, WM, MGUS, or AL clinical trials activated on or after the activation date of this research study (SWOG-S0334)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma
RATIONALE: Studying the chromosomes in samples of bone marrow and blood in the laboratory from patients with cancer or other blood diseases may help doctors learn more about the disease.
PURPOSE: This laboratory study is analyzing chromosomes in patients with newly diagnosed multiple myeloma or other blood disease.
Read the detailed description
OBJECTIVES:
- Compare the frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics in patients with newly diagnosed multiple myeloma (MM) or other monoclonal gammopathies (MG).
- Examine the prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival in these patients.
- Compare the prognostic value of cytogenetics and FISH with other MM and MG prognostic factors in these patients.
- Correlate the presence of cytogenetic and FISH features with clinical pathophysiological, cellular, or other molecular characteristics in these patients.
OUTLINE: Patients receive treatment as directed by the treatment clinical trial on which they are registered. Patients undergo bone marrow or blood sample collection periodically for conventional cytogenetic analysis and fluorescence in situ hybridization studies (FISH). Samples are analyzed for deleted 13q/monosomy 13 and chromosomal abnormalities.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
- Being tested
- cytogenetic analysis, fluorescence in situ hybridization
- Keywords
- Waldenstrom macroglobulinemia, monoclonal gammopathy of undetermined significance, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Precancerous Conditions, Waldenstrom Macroglobulinemia, Monoclonal Gammopathy of Undetermined Significance, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytogenetic analysisGenetic
marrow and peripheral blood
fluorescence in situ hybridizationGenetic
marrow and peripheral blood
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics
Measured: 1 year
Prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival
Measured: 1 year
Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors
Measured: 1 year
Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics
Measured: 1 year
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 startSep 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe 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
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Diane L. Persons, MD, Study chair, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898066
- Sponsor's protocol ID
- S0334
- Other IDs
- U10CA032102, S0334
- Status last verified
- Mar 2015
- First submitted
- 9 May 2009
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytogenetic and Fluorescence In Situ Hybridization Studies in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00898066
- Acronym / sponsor ID
- S0334
- Keywords
- Waldenstrom macroglobulinemia, monoclonal gammopathy of undetermined significance, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 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 the chromosomes in samples of bone marrow and blood in the laboratory from patients with cancer or other blood diseases may help doctors learn more about the disease.
PURPOSE: This laboratory study is analyzing chromosomes in patients with newly diagnosed multiple myeloma or other blood disease.
Detailed description
OBJECTIVES:
- Compare the frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics in patients with newly diagnosed multiple myeloma (MM) or other monoclonal gammopathies (MG).
- Examine the prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival in these patients.
- Compare the prognostic value of cytogenetics and FISH with other MM and MG prognostic factors in these patients.
- Correlate the presence of cytogenetic and FISH features with clinical pathophysiological, cellular, or other molecular characteristics in these patients.
OUTLINE: Patients receive treatment as directed by the treatment clinical trial on which they are registered. Patients undergo bone marrow or blood sample collection periodically for conventional cytogenetic analysis and fluorescence in situ hybridization studies (FISH). Samples are analyzed for deleted 13q/monosomy 13 and chromosomal abnormalities.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pts from S0115, S0232, S0340, S0417 and all new SWOG MM SM, WM, MGUS studies after 9/1/05 before closure
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 |
|---|---|---|
| cytogenetic analysismarrow and peripheral blood | Genetic | – |
| fluorescence in situ hybridizationmarrow and peripheral blood | Genetic | – |
Primary outcome
Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics
Time frame: 1 year
Prognostic value of specific subsets of chromosome aberrations detected by conventional cytogenetics and FISH in relation to event-free and overall survival
Time frame: 1 year
Comparison of prognostic value of cytogenetics and FISH with other multiple myeloma and monoclonal gammopathy prognostic factors
Time frame: 1 year
Correlation between the presence of cytogenetic and FISH features and clinical pathophysiological, cellular, or other molecular characteristics
Time frame: 1 year
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 6 Mar 2015.
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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.
Diane L. Persons, MD study chair
University of Kansas
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. 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?
Frequency of deletion 13 as detected by fluorescence in situ hybridization (FISH) and conventional cytogenetics (time frame: 1 year). The study lists 4 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 6 Mar 2015.