A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance

NCT ID: NCT02849444

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 326 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-23
• Study Completion Date: 2020-12-10

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.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Moderate kidney failure

30 ≤ CrCl \< 50 mL/min/1.73 m2

Anti-myeloma treatment at physician discretion

Intervention Type: OTHER

non Interventional Study

Severe kidney failure

CrCl \< 30 mL/min/1.73 m2

Anti-myeloma treatment at physician discretion

Intervention Type: OTHER

non Interventional Study

Interventions

Anti-myeloma treatment at physician discretion

non Interventional Study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients of both genders, aged equal or more than 18 years.

2. Patients with documented relapsed multiple myeloma according to International Myeloma Working Group ( IMWG) criteria.

3. Patients with documented renal damage defined as creatinine clearance <50 ml / min / 1.73 m2 (CrCl <50ml / min / 1.73m2).

4. Patients to whom the researcher decides to initiate anti-myeloma treatment for relapse with one or more agents according to clinical practice *.

5. Patients who consent in writing after it has been clearly explained to them the nature and purpose of the study (written informed consent).

6. Subject with any of the following characteristics (at least one of the 2 following options must be Yes):

• Subjects who have not previously participated in the study

• The decision to prescribe treatment will be clearly dissociated from the decision to include the patient in the study

• Clarification is provided as to the aim of the study, which is to encompass all relapse subcategories included in the International Myeloma Working Group consensus document published in 2006. Therefore, all patients with clinically relapsed multiple myeloma, who are in relapse following a complete response or in progression (including refractory cases) as defined in point 8.1 and in table 4 of the protocol, are considered eligible candidates for participation in the EPA-MIR 50 study, as long as they meet all the other criteria

Exclusion Criteria

1. Patients who are participating in an interventional clinical trial * or who refuse to participate in the study.

2. Patients with CrCl <50 ml / min / 1.73m2 due to a cause other than multiple myeloma properly documented at the discretion of the investigator *.

• The inclusion of patients who are participating in another observational study is permitted.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mireya Navarro, MD

Role: STUDY_DIRECTOR

Celgene Spain

Locations

Hospital Torrecárdenas

Almería, Andalusia, Spain

Hospital Universitario Puerta del Mar

Cadiz, Andalusia, Spain

Hospital Virgen de la Nieves

Granada, Andalusia, Spain

Hospital Universitario Ciudad de Jaen

Jaén, Andalusia, Spain

Hospital general de jeréz

Jerez de la Frontera, Andalusia, Spain

Hospital Virgen de la macarena

Seville, Andalusia, Spain

Hospital Miguel Servet

Zaragoza, Aragon, Spain

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital de Insular de Gran Canaria

Las Palmas de Gran Canaria, Canary Islands, Spain

Hospital de Basurto

Bilbao, Castille and León, Spain

Hospital de Burgos

Burgos, Castille and León, Spain

Hospital de León

León, Castille and León, Spain

Rio Hortega de Valladolid

Valladolid, Castille and León, Spain

Hospital General de Ciudad Real

Ciudad Real, Castille-La Mancha, Spain

Hospital La Ribera

Alzira, Catalonia, Spain

Hospital del Mar

Barcelona, Catalonia, Spain

Hospital Vall d´Hebron

Barcelona, Catalonia, Spain

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalonia, Spain

Hospital Duran reynls

Barcelona, Catalonia, Spain

Hospital Universitario Josep Trueta de Girona

Girona, Catalonia, Spain

Hospital Arnau de Vilanova de Lleida

Lleida, Catalonia, Spain

Hospital Sant Joan de manresa

Manresa, Catalonia, Spain

Hospital de Sabadell ( Parc Taulí)

Sabadell, Catalonia, Spain

Hospital Mutua terrassa

Terrassa, Catalonia, Spain

Complejo Hospitalario Universitario Santiago

Santiago de Compostela, Galicia, Spain

Complejo Hospitalario Universitario de Vigo

Vigo, Galicia, 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 de Cabueñes

Gijón, Principality of Asturias, Spain

Hospital General de Alicante

Alicante, Valencia, Spain

Hospital Clínico Universitario Valencia

Valencia, Valencia, Spain

Hospital La fe

Valencia, 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

Countries

Spain

Other Identifiers

CEL-MIE-2012-01

Identifier Type: -

Identifier Source: org_study_id