An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants
This is a non-interventional, observational study. Multiple myeloma will be treated as per standard therapy and/or with medicinal product prescribed by the treating healthcare provider based upon his/her clinical judgment.
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Males and females age 18 or older (adults)
Key inclusion criteria:
- Signed informed consent to participate
- 3. Patients willing and able to complete Patient Reported Outcomes in accordance with local regulatory and data protection requirements will be enrolled.
- Patient is experiencing one of the following:
a) Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM- directed treatment history, including duration.
b) Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether
consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens.
Key exclusion criteria:
- 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.
- Participation in another study (observational or interventional) that prohibits participation in this study.
Primary disease category: Cancer
Sponsor: Millennium Pharmaceuticals, Inc (Takeda Pharmaceutical)
Projected enrollment dates: April 2017 to June 2024
Official study title: A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT-MM Study