Spots Global Cancer Trial Database for A Study to Investigate the Relationship Between Duration of Treatment and Response in Patients With Multiple Myeloma (MM) or Systemic AL Amyloidosis Treated in Real-life Practice
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Trial Identification
Brief Title: A Study to Investigate the Relationship Between Duration of Treatment and Response in Patients With Multiple Myeloma (MM) or Systemic AL Amyloidosis Treated in Real-life Practice
Official Title: Prospective Non-interventional Study to Investigate the Relationship Between Duration of Treatment (DoT) and Response in Patients With Multiple Myeloma or Systemic AL Amyloidosis Treated in Real-life Clinical Practice
Study ID: NCT04659798
Interventions
Study Description
Brief Summary: The study will provide information on outcomes in people with multiple myeloma, or systemic AL amyloidosis, or both, under standard care. AL is short for amyloid light-chain. Standard care means the participant will be treated according to their clinic's standard practice. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. The aim of the study is to learn if treatment duration makes a difference in how participants with multiple myeloma or systemic AL amyloidosis respond to their treatment. During the study, participants will be treated according to their clinic's standard practice. Participants must have started their treatment up to 12 months before taking part in this study. During the study, the participants will visit their clinic every 3 months. These are extra visits to their clinic's standard visits.
Detailed Description: This is a prospective non-interventional study to assess the DoT and response in participants with MM or systemic AL amyloidosis in standard clinical practice. This study will enroll approximately 250 participants (220 with MM and 30 with systemic AL amyloidosis). Participants will be enrolled in 2 groups: Participants with MM Participants with AL amyloidosis The study will have a prospective data collection of the participants from clinical records and scheduled visits following the routine clinical practice. All participants will receive treatment at study start and this treatment must have been started within 12 months before the participant's enrollment. This multi-center study will be conducted in Spain. Participants will be followed until 12 months after enrollment. The overall time to participate in this study is approximately 1 year.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Puerta del Mar, Cadiz, Andalucia, Spain
Hospital Regional Universitario de Malaga (Carlos de Haya), Malaga, Andalucia, Spain
H. Universitario de Cabuenes, Gijon, Asturias, Spain
C.H.U. Canarias, La Laguna, Canarias, Spain
H. Universitario Marques de Valdecilla, Santander, Cantabria, Spain
H. Universitario de Leon, Leon, Castilla Y Leon, Spain
C.H. Salamanca, Salamanca, Castilla Y Leon, Spain
H. Universitario Lucus Agusti, Lugo, Galicia, Spain
C.H.U. Santiago, Santiago de Compostela, Galicia, Spain
H. Universitari Son Espases, Palma de Mallorca, Islas Baleares, Spain
Hospital General Universitario Santa Lucia, Cartagena, Murcia, Spain
H. Universitario de Araba, Vitoria, Pais Vasco, Spain
Hospital Universitario de Burgos, Burgos, , Spain
H. Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Contact Details
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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