MIR50: A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT02849444

Collaborator

(none)

326

Enrollment

Locations

98.6

Actual Duration (Months)

8.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: Anti-myeloma treatment at physician discretion

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:

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.
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.

Study Design

Study Type:

Observational

Actual Enrollment :

326 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Sep 23, 2012

Actual Primary Completion Date :

Dec 23, 2019

Actual Study Completion Date :

Dec 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Moderate kidney failure 30 ≤ CrCl < 50 mL/min/1.73 m2	Other: Anti-myeloma treatment at physician discretion non Interventional Study
Severe kidney failure CrCl < 30 mL/min/1.73 m2	Other: Anti-myeloma treatment at physician discretion non Interventional Study

Arm

Intervention/Treatment

Moderate kidney failure

30 ≤ CrCl < 50 mL/min/1.73 m2

Other: Anti-myeloma treatment at physician discretion

non Interventional Study

Severe kidney failure

CrCl < 30 mL/min/1.73 m2

Other: Anti-myeloma treatment at physician discretion

non Interventional Study

Outcome Measures

Primary Outcome Measures

Creatinine levels to determinates Renal function response [Up to 12 months]
Creatinine records from basal visit to last visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
Age of participants at baseline to determinates Renal function response [Baseline visit]
Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.
Weight of participants at baseline to determinates Renal function response [Baseline visit]
Patient weight recorded in each visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
Gender of participants at baseline to determinates Renal function response [Baseline visit]
Patient gender recorded in basal visit to determinates Creatinine clearance with the Cockcroft-Gault formula.

Secondary Outcome Measures

Race of participants at Baseline [Baseline visit]
To describe the demographic characteristics of patients with relapsed multiple myeloma and CrCl <50 mL/min/1.73 m2.
Clinical Outcome of participants with Multiple Myeloma (MM) clinical description [Up to 12 months]
To describe the clinical characteristics of patients with relapsed multiple myeloma and CrCl <50 mL/min/1.73 m2.
Renal response rate assessment in clinical practice. [Up to 12 months]
Describe response rate of renal function according to eGFR and total proteinuria
Time dependent Renal response rate assessment in clinical practice. [Up to 12 months]
Time to best renal response
Type of Anti-myeloma therapeutic regimens. [Up to 12 months]
Describe various types of anti-myeloma regimens participants will receive.
Multiple Myeloma (MM) response to anti-myeloma treatment [Up to 12 months]
MM response evaluation according to IMWG criteria
MM response to Time to Progression [Up to 12 months]
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.
MM response to Time to first response [Up to 12 months]
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.
MM response to Progression Free Survival [Up to 12 months]
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.
Adverse events (AEs) [Up to 12 months]
Number of participants with adverse events
Cost of visit to hospital/primary health care associated with anti-myeloma therapy [Up to 12 months]
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.
Number of participants with relapsed kidney function [Up to 36 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients of both genders, aged equal or more than 18 years.
Patients with documented relapsed multiple myeloma according to International Myeloma Working Group ( IMWG) criteria.
Patients with documented renal damage defined as creatinine clearance <50 ml / min / 1.73 m2 (CrCl <50ml / min / 1.73m2).
Patients to whom the researcher decides to initiate anti-myeloma treatment for relapse with one or more agents according to clinical practice *.
Patients who consent in writing after it has been clearly explained to them the nature and purpose of the study (written informed consent).
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Ciudad de Jaen	Jaen	Andalucia	Spain	23007
2	Hospital Torrecárdenas	Almería	Andalucía	Spain	04009
3	Hospital Universitario Puerta del Mar	Cádiz	Andalucía	Spain	11009
4	Hospital Virgen de la Nieves	Granada	Andalucía	Spain	18014
5	Hospital general de jeréz	Jerez de la Frontera	Andalucía	Spain	11407
6	Hospital Virgen de la macarena	Sevilla	Andalucía	Spain	41071
7	Hospital Miguel Servet	Zaragoza	Aragón	Spain	50009
8	Hospital de Cabueñes	Gijón	Asturias	Spain	33394
9	Hospital de Insular de Gran Canaria	Las Palmas de Gran Canaria	Canarias	Spain	35010
10	Hospital General de Ciudad Real	Ciudad Real	Castilla La Mancha	Spain	13005
11	Hospital de Basurto	Bilbao	Castilla Y León	Spain	48013
12	Hospital de Burgos	Burgos	Castilla Y León	Spain	09007
13	Hospital de León	León	Castilla Y León	Spain	24001
14	Rio Hortega de Valladolid	Valladolid	Castilla Y León	Spain	47003
15	Hospital La Ribera	Alzira	Cataluña	Spain	46600
16	Hospital del Mar	Barcelona	Cataluña	Spain	08003
17	Hospital Vall d´Hebron	Barcelona	Cataluña	Spain	08035
18	Hospital Clinic I Provincial de Barcelona	Barcelona	Cataluña	Spain	08208
19	Hospital Duran reynls	Barcelona	Cataluña	Spain	08907
20	Hospital Universitario Josep Trueta de Girona	Girona	Cataluña	Spain	17007
21	Hospital Arnau de Vilanova de Lleida	Lleida	Cataluña	Spain	25198
22	Hospital Sant Joan de manresa	Manresa	Cataluña	Spain	08243
23	Hospital de Sabadell ( Parc Taulí)	Sabadell	Cataluña	Spain	08208
24	Hospital Mutua terrassa	Terrassa	Cataluña	Spain	08221
25	Hospital Clínico Universitario Valencia	Valencia	Comunidad Valenciana	Spain	46010
26	Hospital La fe	Valencia	Comunidad Valenciana	Spain	46026
27	Complejo Hospitalario Universitario Santiago	Santiago de Compostela	Galicia	Spain	15006
28	Complejo Hospitalario Universitario de Vigo	Vigo	Galicia	Spain	36036
29	Hospital Son Espases	Palma de Mallorca	Islas Baleares	Spain	07120
30	Hospital san pedro	Logroño	La Rioja	Spain	26006
31	Hospital Fundación de Alcorcón	Alcorcón	Madrid	Spain	28922
32	Hospital Puerta de Hierro	Majadahonda	Madrid	Spain	28222
33	Hospital Santa Lucía	Cartagena	Murcia	Spain	30202
34	Hospital Virgen de Arrixaca	El Palmar, Murcia	Murcia	Spain	30120
35	Hospital General de Alicante	Alicante	Valencia	Spain	03010
36	Hospital Gregorio marañon	Madrid		Spain	28007
37	Hospital Ramon y Cajal	Madrid		Spain	28034
38	Complejo Universitario de San Carlos	Madrid		Spain	28040
39	Hospital Universitario La paz	Madrid		Spain	28046
40	Hospital Dr peset	Valencia		Spain	46017