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Spots Global Cancer Trial Database for A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Mireya Navarro, MD

Affiliation: Celgene Spain

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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