Cytogenetic Studies in Acute Leukemia and Multiple Myeloma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Multiple Myeloma

Intervention / Treatment
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* Genetic: cytogenetic analysis


Participation Criteria
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Eligibility Criteria
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Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct. Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients. Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>Samples as defined per the protocol for previously untreated patients with AML, ALL, MDS or MM will be submitted for analysis and within one month patients are required to register onto a CALGB treatment study. | Genetic: cytogenetic analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM |  | Up to 10 years | 
| Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters |  | 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 |  | Up to 10 years | 
| Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols |  | Up to 10 years | 
| To correlate specific karyotype groups with multidrug resistance data |  | Up to 10 years | 
| To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history) |  | 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 |  | up to 10 yeras | 
| To identify new chromosome abnormalities important in leukemogenesis |  | Up to 10 years |