Cytogenetic Studies in Acute Leukemia and Multiple Myeloma: Companion to CALGB Treatment Studies For Previously Untreated Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM) Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 9,000
- Locations
- 137
- Primary Endpoint
- Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols
Study Overview
Brief Summary
Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols
Time Frame: Up to 10 years
To correlate specific karyotype groups with multidrug resistance data
Time Frame: Up to 10 years
Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM
Time Frame: Up to 10 years
Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters
Time Frame: Up to 10 years
Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens
Time Frame: Up to 10 years
To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history)
Time Frame: Up to 10 years
To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course
Time Frame: up to 10 yeras
To identify new chromosome abnormalities important in leukemogenesis
Time Frame: Up to 10 years
Secondary Outcomes
No secondary outcomes reported