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Protocol No. UW16128
Principal Investigator Callander, Natalie
Age Group Adult
Sponsor Type Industry
Title A global, prospective, non-interventional, observational study of presentation, treatment patterns, and outcomes in multiple myeloma patients-the INSIGHT-MM study
Objective To assist in the improvement of medical care, it is important to collect scientific information about the safety and effectiveness of medicines, including medicines used to treat multiple myeloma. The purpose of this observational study is to collect medical information regarding your medical history and how your condition is managed during your routine treatment. However, you will also be invited to complete a patient survey and validated questionnaires during the course of the study, using a secure electronic data collection system.
Treatment This observational study is intended to capture information about current practices in the management of multiple myeloma without making any specific change to the treatment(s) selected by your doctor as a standard of care.
Description Participants in this observational study will not have to undergo any study specific procedures. All assessments (for example, blood samples or urine specimens) will be part of the routine treatment and management of patients with multiple myeloma. No additional procedures or examinations are required to take part in the study. However, you will be invited to complete a patient survey and validated questionnaires at home or at routine clinics/office visits using a secure electronic data collection system or paper questionnaires as per local regulations.
- Must be newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, stage, and MM-directed treatment history, including duration OR relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record
- Patients willing and able to complete Patient Reported Outcomes in accordance with local regulatory and data protection requirements will be enrolled
- 18 years of age or older
- Patients reporting to a site in this study for a second opinion (consultation only) or patients whose frequency of consult and follow-up are not adequate for quarterly eCRF completion will be ineligible
- Patients will be ineligible if participation in another study prohibits participation in this study
Applicable Disease Sites Multiple Myeloma
Participating Institutions UW Hospital and Clinics