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Brief Title: A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance
Official Title: Post-authorisation Observational Study for the Assessment of Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance <50 mL/Min/1.73 m2 (CrCl <50 mL/Min/1.73 m2)
Study ID: NCT02849444
Brief Summary: A prospective, multicentre, post-authorisation observational study. The objective of this study is assess the response of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed MM and CrCl \<50 mL/min/1.73 m2.
Detailed Description: Prospective, multicentre, post-authorisation observational study. Study population: Patients with relapsed multiple myeloma and with CrCl \<50 mL/min/1.73 m2, for whom the investigator decides to start a new line of anti-myeloma treatment as per normal clinical practice. The decision to prescribe treatment will be clearly disassociated from the decision to include the patient in the study. 300 patients are expected to be recruited (225 for Group 1 and 75 for Group 2) from 40 sites (approximately 7-8 patients for each site). Patients will be included consecutively in the study. The inclusion will be stratified to ensure the presence of all stages of renal impairment (RI) in two groups: Documentation of 300 patients is planned (a maximum of 225 in group 1 and a minimum of 75 in group 2) at 40 sites (approximately 7-8 patients per each site). The patients will be included in the study in a consecutive manner. In order to ensure the correct stratification of the sample group a real time central registry will be kept for the patients included in each group. Once the required number of patients for one of the groups is completed, inclusion in that group will be closed at all sites, keeping inclusion for other groups open, and so on until the entire sample size is complete. Primary objective: To assess the response of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed MM and creatinine clearance \<50 mL/min/1.73 m2 (CrCl \<50 mL/min/1.73m2). The prospective follow-up period will cover two phases: 1. Treatment phase: covers the entire time the patient is receiving the first anti-myeloma treatment for relapse\* for which he/she is included in this study. 2. Follow-up phase: A 36-month extension period after the end of the first anti-myeloma treatment for relapse for which he/she was included in the study. * Any change in therapeutic regimens, for example, discontinuation or addition of a drug (except for changes in dose for some of the initial drugs) will mark the end of the treatment phase and the passing of the patient to the follow-up phase. In case of temporary interruptions in treatment under 30 days (or of any duration if the reason for interruption is toxicity) the patient will continue in the treatment phase, provided that the initial treatment regimen for the relapse it resumed. Secondary objectives: * To describe the clinical and demographic characteristics of patients with relapsed multiple myeloma and CrCl \<50 mL/min/1.73 m2. * To assess the response rate of renal function in clinical practice to anti-multiple myeloma therapy in patients with relapsed multiple myeloma and CrCl \<50 mL/min/1.73 m2. * To assess the response of renal function based on the therapeutic regimens administered. * To explore the concordance of the kidney function response and that of the myeloma in the clinical practice to the anti-myeloma treatment between consecutive relapses in the same patient. * To assess time-dependent response parameters. * To analyse the safety of treatments administered in clinical practice. * To describe the use of resources associated with anti-myeloma therapy in clinical practice that can be measured financially, and to explore the possible differences between the various therapeutic regimens administered.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Universitario Ciudad de Jaen, Jaen, Andalucia, Spain
Hospital Torrecárdenas, Almería, Andalucía, Spain
Hospital Universitario Puerta del Mar, Cádiz, Andalucía, Spain
Hospital Virgen de la Nieves, Granada, Andalucía, Spain
Hospital general de jeréz, Jerez de la Frontera, Andalucía, Spain
Hospital Virgen de la macarena, Sevilla, Andalucía, Spain
Hospital Miguel Servet, Zaragoza, Aragón, Spain
Hospital de Cabueñes, Gijón, Asturias, Spain
Hospital de Insular de Gran Canaria, Las Palmas de Gran Canaria, Canarias, Spain
Hospital General de Ciudad Real, Ciudad Real, Castilla La Mancha, Spain
Hospital de Basurto, Bilbao, Castilla Y León, Spain
Hospital de Burgos, Burgos, Castilla Y León, Spain
Hospital de León, León, Castilla Y León, Spain
Rio Hortega de Valladolid, Valladolid, Castilla Y León, Spain
Hospital La Ribera, Alzira, Cataluña, Spain
Hospital del Mar, Barcelona, Cataluña, Spain
Hospital Vall d´Hebron, Barcelona, Cataluña, Spain
Hospital Clinic I Provincial de Barcelona, Barcelona, Cataluña, Spain
Hospital Duran reynls, Barcelona, Cataluña, Spain
Hospital Universitario Josep Trueta de Girona, Girona, Cataluña, Spain
Hospital Arnau de Vilanova de Lleida, Lleida, Cataluña, Spain
Hospital Sant Joan de manresa, Manresa, Cataluña, Spain
Hospital de Sabadell ( Parc Taulí), Sabadell, Cataluña, Spain
Hospital Mutua terrassa, Terrassa, Cataluña, Spain
Hospital Clínico Universitario Valencia, Valencia, Comunidad Valenciana, Spain
Hospital La fe, Valencia, Comunidad Valenciana, Spain
Complejo Hospitalario Universitario Santiago, Santiago de Compostela, Galicia, Spain
Complejo Hospitalario Universitario de Vigo, Vigo, Galicia, Spain
Hospital Son Espases, Palma de Mallorca, Islas Baleares, Spain
Hospital san pedro, Logroño, La Rioja, Spain
Hospital Fundación de Alcorcón, Alcorcón, Madrid, Spain
Hospital Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Santa Lucía, Cartagena, Murcia, Spain
Hospital Virgen de Arrixaca, El Palmar, Murcia, Murcia, Spain
Hospital General de Alicante, Alicante, Valencia, Spain
Hospital Gregorio marañon, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Complejo Universitario de San Carlos, Madrid, , Spain
Hospital Universitario La paz, Madrid, , Spain
Hospital Dr peset, Valencia, , Spain
Name: Mireya Navarro, MD
Affiliation: Celgene Spain
Role: STUDY_DIRECTOR