Inflammatory Cytokines in Symptom Production in Multiple Myeloma
Tracking Information | |||||
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First Received Date ICMJE | May 28, 2008 | ||||
Last Updated Date | July 25, 2012 | ||||
Start Date ICMJE | May 2008 | ||||
Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Multiple myeloma module of MDASI (MDASI-MM) Questionnaire [ Time Frame: Baseline with 12 Month Longitudinal Assessment ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
The goal of this research study is to learn about the pain and/or other symptoms that patients may experience during and after treatment for MM and how these symptoms may affect therapy. [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00688168 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Inflammatory Cytokines in Symptom Production in Multiple Myeloma | ||||
Official Title ICMJE | Identifying the Role of Inflammatory Cytokines in Symptom Production in Multiple Myeloma | ||||
Brief Summary | The goal of this research study is to learn about the pain and/or other symptoms that patients may experience during and after treatment for MM and how these symptoms may affect therapy. A second goal is to learn how differences in genes may affect the symptom burden from cancer and cancer therapy. |
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Detailed Description | If you agree to take part in this study, you will complete 4 questionnaires during a regularly schedule clinic visit. These questionnaires will measure pain and other symptoms, such as your mood and quality of life. You will also be asked to give a tissue sample by inserting a swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about a minute at most. Completing the 5 questionnaires and the swab sample collection takes about 30 minutes in total. Length of Study: After you have completed the 5 questionnaires and the swab sample collection, your participation in this study will be over. This is an investigational study. Up to 500 patients will take part in the cross-sectional phase of this study. All will be enrolled at MD Anderson. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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Biospecimen | Retention: Samples With DNA Description: Tissue sample by inserting a swab into mouth and rubbing firmly against the inside of cheeck or underneath lower or upper lip for about a minute during a regularly schedule clinic visit. |
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Sampling Method | Non-Probability Sample | ||||
Study Population | Patients, 18 years or older, diagnosed with multiple myeloma (MM). |
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Condition ICMJE | Multiple Myeloma | ||||
Intervention ICMJE |
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Study Group/Cohort (s) | Symptom Assessments
Patients diagnosed with multiple myeloma (MM)
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 500 | ||||
Completion Date | |||||
Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00688168 | ||||
Other Study ID Numbers ICMJE | 2007-0612 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | AstraZeneca | ||||
Investigators ICMJE |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |