Multiple Myeloma Clinical Trial
Official title:
Etiology of Multiple Myeloma: A Case-Control Study
Objectives:
The overall objective of this project is to identify risk factors associated with the
development of multiple myeloma (MM) by integrating epidemiologic, clinical and molecular
information. We plan to invite MDACC patients with MM, as well as controls, to participate in
this investigative case-control study. Controls will be selected from friends and spouses who
accompany patients to the various MDACC clinics and will be matched to the cases on age (±5
years), gender, and ethnicity. We will obtain demographic, risk factor and clinical
information along with a blood and buccal sample from all cases and controls. This study
could have implications for prevention and subsequent reduction in the incidence of multiple
myeloma. Collecting blood and buccal samples will allow us to study the role genetic
susceptibility plays in MM risk. The specific aims are:
1. To enroll and obtain, through self-administered questionnaires, risk factor information
on all study participants to develop detailed demographic, epidemiologic, and behavioral
profiles. This study will accrue 250 MM patients from MDACC and 250 healthy controls
selected from friends and spouses who accompany patients to the MDACC clinics. Blood (25
ml) and buccal samples will be collected from all participants.
2. To identify risk factors associated with MM by integrating epidemiological, clinical and
molecular information using a case-control approach.
3. To evaluate constitutional markers of genetic susceptibility as predictors of MM risk.
Gene-environment interactions will be explored.
Informed Consent For Control Subjects:
In this study, researchers are trying to learn about factors that may be associated with MM.
For this study, you will be asked to complete a questionnaire. The questionnaire asks
questions about your demographics (for example, age and sex), any chemicals you may have been
exposed to, your medical history, family history of cancer, your diet, and your history of
smoking and/or alcohol use. It should take around 30-40 minutes to complete the
questionnaire.
Blood (about 2-3 tablespoons) will be drawn. You will spit into a collection container in
order to provide a sample of your saliva. The blood and saliva samples will be used for
special tests to look for any biological factors associated with MM.
If you live in Houston or the surrounding area, study personnel can arrange to collect the
samples at the time and place of your convenience. If you do not live in the Houston area,
sample collection instructions and supplies will be mailed to you. The blood sample may be
drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs
will be paid by the study. No travel to M. D. Anderson will be required.
You will be considered off-study after the data that is collected has been processed.
This is an investigational study. Up to 500 participants will take part in this study. All
will be enrolled at M. D. Anderson.
Informed Consent for Patients:
In this study, researchers are trying to learn about factors that may be associated with MM.
For this study, you will be asked to complete a questionnaire. The questionnaire asks
questions about your demographics (for example, age and sex), any chemicals you may have been
exposed to, your medical history, family history of cancer, your diet, and your history of
smoking and/or alcohol use. It should take around 30-40 minutes to complete the
questionnaire.
Blood (about 2-3 tablespoons) will be drawn. You will spit into a collection container in
order to provide a sample of your saliva. The blood and saliva samples will be used for
special tests to look for any biological factors associated with MM.
If you live in Houston or the surrounding area, study personnel can arrange to collect the
samples at the time and place of your convenience. If you do not live in the Houston area,
sample collection instructions and supplies will be mailed to you. The blood sample may be
drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs
will be paid by the study. No travel to M. D. Anderson will be required.
Neither you nor your doctor will receive the results of these tests, and they will not be put
in your medical record.
You will be considered off study after the data that is collected has been processed.
This is an investigational study. Up to 500 participants will take part in this study. All
will be enrolled at M. D. Anderson.
;
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