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Etiology of Multiple Myeloma: A Case-Control Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00505999
First received: July 24, 2007
Last updated: November 9, 2016
Last verified: November 2016
  Purpose

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.

Condition Intervention
Multiple Myeloma
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Etiology of Multiple Myeloma: A Case-Control Study

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood and saliva samples that will be used for special tests to look for any biological factors associated with Multiple Myemloma (MM).

Estimated Enrollment: 500
Study Start Date: July 2006
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire
Patients diagnosed with Multiple Myeloma and healthy controls.
Behavioral: Questionnaire
Questionnaire taking 30-40 minutes to complete.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Multiple Myeloma and healthy controls.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505999

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michelle Hildebrandt, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505999     History of Changes
Other Study ID Numbers: 2006-0141  R25CA057730 
Study First Received: July 24, 2007
Last Updated: November 9, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Etiology
Risk Factors
Healthy Controls
Questionnaire
Survey

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2016