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

Multiple Myeloma Clinical Trial

— MIR50  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849444
• Other study ID #: CEL-MIE-2012-01
• Status: Completed
• Start date: September 23, 2012
• Est. completion date: December 10, 2020

Study information

• Verified date: August 2021
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: December 10, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Subjects who have previously participated in the study, who meet all the inclusion criteria again and to whom none of the exclusion criteria apply, and whose current relapse is consecutive to the relapse that prompted their initial inclusion 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Anti-myeloma treatment at physician discretion
non Interventional Study

Locations

Country	Name	City	State
Spain	Hospital Fundación de Alcorcón	Alcorcón	Madrid
Spain	Hospital General de Alicante	Alicante	Valencia
Spain	Hospital Torrecárdenas	Almería	Andalucía
Spain	Hospital La Ribera	Alzira	Cataluña
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona	Cataluña
Spain	Hospital del Mar	Barcelona	Cataluña
Spain	Hospital Duran reynls	Barcelona	Cataluña
Spain	Hospital Vall d´Hebron	Barcelona	Cataluña
Spain	Hospital de Basurto	Bilbao	Castilla Y León
Spain	Hospital de Burgos	Burgos	Castilla Y León
Spain	Hospital Universitario Puerta del Mar	Cádiz	Andalucía
Spain	Hospital Santa Lucía	Cartagena	Murcia
Spain	Hospital General de Ciudad Real	Ciudad Real	Castilla La Mancha
Spain	Hospital Virgen de Arrixaca	El Palmar, Murcia	Murcia
Spain	Hospital de Cabueñes	Gijón	Asturias
Spain	Hospital Universitario Josep Trueta de Girona	Girona	Cataluña
Spain	Hospital Virgen de la Nieves	Granada	Andalucía
Spain	Hospital Universitario Ciudad de Jaen	Jaen	Andalucia
Spain	Hospital general de jeréz	Jerez de la Frontera	Andalucía
Spain	Hospital de Insular de Gran Canaria	Las Palmas de Gran Canaria	Canarias
Spain	Hospital de León	León	Castilla Y León
Spain	Hospital Arnau de Vilanova de Lleida	Lleida	Cataluña
Spain	Hospital san pedro	Logroño	La Rioja
Spain	Complejo Universitario de San Carlos	Madrid
Spain	Hospital Gregorio marañon	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario La paz	Madrid
Spain	Hospital Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Sant Joan de manresa	Manresa	Cataluña
Spain	Hospital Son Espases	Palma de Mallorca	Islas Baleares
Spain	Hospital de Sabadell ( Parc Taulí)	Sabadell	Cataluña
Spain	Complejo Hospitalario Universitario Santiago	Santiago de Compostela	Galicia
Spain	Hospital Virgen de la macarena	Sevilla	Andalucía
Spain	Hospital Mutua terrassa	Terrassa	Cataluña
Spain	Hospital Clínico Universitario Valencia	Valencia	Comunidad Valenciana
Spain	Hospital Dr peset	Valencia
Spain	Hospital La fe	Valencia	Comunidad Valenciana
Spain	Rio Hortega de Valladolid	Valladolid	Castilla Y León
Spain	Complejo Hospitalario Universitario de Vigo	Vigo	Galicia
Spain	Hospital Miguel Servet	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine levels to determinates Renal function response	Creatinine records from basal visit to last visit to determinates Creatinine clearance with the Cockcroft-Gault formula.	Up to 12 months
Primary	Age of participants at baseline to determinates Renal function response	Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.	Baseline visit
Primary	Weight of participants at baseline to determinates Renal function response	Patient weight recorded in each visit to determinates Creatinine clearance with the Cockcroft-Gault formula.	Baseline visit
Primary	Gender of participants at baseline to determinates Renal function response	Patient gender recorded in basal visit to determinates Creatinine clearance with the Cockcroft-Gault formula.	Baseline visit
Secondary	Race of participants at Baseline	To describe the demographic characteristics of patients with relapsed multiple myeloma and CrCl <50 mL/min/1.73 m2.	Baseline visit
Secondary	Clinical Outcome of participants with Multiple Myeloma (MM) clinical description	To describe the clinical characteristics of patients with relapsed multiple myeloma and CrCl <50 mL/min/1.73 m2.	Up to 12 months
Secondary	Renal response rate assessment in clinical practice.	Describe response rate of renal function according to eGFR and total proteinuria	Up to 12 months
Secondary	Time dependent Renal response rate assessment in clinical practice.	Time to best renal response	Up to 12 months
Secondary	Type of Anti-myeloma therapeutic regimens.	Describe various types of anti-myeloma regimens participants will receive.	Up to 12 months
Secondary	Multiple Myeloma (MM) response to anti-myeloma treatment	MM response evaluation according to IMWG criteria	Up to 12 months
Secondary	MM response to Time to Progression	Time to progression is defined as time from baseline to the appearance of the event; considering as an event progression or death from any cause.	Up to 12 months
Secondary	MM response to Time to first response	Time to response is defined as time from the date of the first dose of study treatment to the date of the first documented hematologic improvement.	Up to 12 months
Secondary	MM response to Progression Free Survival	Progression free survival is defined as time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse per IWG 2006 criteria.	Up to 12 months
Secondary	Adverse events (AEs)	Number of participants with adverse events	Up to 12 months
Secondary	Cost of visit to hospital/primary health care associated with anti-myeloma therapy	To describe the costs 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. This includes, visits to hospital/primary health care center.	Up to 12 months
Secondary	Number of participants with relapsed kidney function	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.	Up to 36 months