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NCT00505999 Clinical Trial

Etiology of Multiple Myeloma: A Case-Control Study

Multiple Myeloma Clinical Trial

Official title:
Etiology of Multiple Myeloma: A Case-Control Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00505999
Other study ID # 2006-0141
Secondary ID R25CA057730
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2006
Est. completion date July 2020

Study information
Verified date December 2019
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 140
Est. completion date July 2020
Est. primary completion date July 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Cases: MDACC patients with confirmed MM who consent to complete a risk factor questionnaire and donate a 25ml blood specimen and a buccal sample.

2. Controls: Friends or spouses of MDACC patients matched on age (± 5 years), sex and ethnicity who consent to complete a risk factor questionnaire and donate a 25 ml blood specimen and a buccal sample.

Exclusion Criteria:

1. Cases: No exclusion criteria.

2. Controls: Previous history of invasive cancer (excluding non-melanoma skin cancer)

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Questionnaire
Questionnaire taking 30-40 minutes to complete.

Locations
Country Name City State
United States University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The goal of this epidemiological research study is to identify biological and lifestyle factors that may be associated with the development of Multiple Myeloma (MM). 2 Years
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
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