A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance
- Conditions
- Multiple Myeloma
- Interventions
- Other: Anti-myeloma treatment at physician discretion
- Registration Number
- NCT02849444
- Lead Sponsor
- Celgene
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
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Patients of both genders, aged equal or more than 18 years.
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Patients with documented relapsed multiple myeloma according to International Myeloma Working Group ( IMWG) criteria.
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Patients with documented renal damage defined as creatinine clearance <50 ml / min / 1.73 m2 (CrCl <50ml / min / 1.73m2).
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Patients to whom the researcher decides to initiate anti-myeloma treatment for relapse with one or more agents according to clinical practice *.
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Patients who consent in writing after it has been clearly explained to them the nature and purpose of the study (written informed consent).
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Subject with any of the following characteristics (at least one of the 2 following options must be Yes):
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Subjects who have not previously participated in the study
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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.
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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
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Patients who are participating in an interventional clinical trial * or who refuse to participate in the study.
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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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Severe kidney failure Anti-myeloma treatment at physician discretion CrCl \< 30 mL/min/1.73 m2 Moderate kidney failure Anti-myeloma treatment at physician discretion 30 ≤ CrCl \< 50 mL/min/1.73 m2
- Primary Outcome Measures
Name Time Method Age of participants at baseline to determinates Renal function response Baseline visit Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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
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.
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.
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.
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
Adverse events (AEs) Up to 12 months Number of participants with adverse events
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.
Trial Locations
- Locations (40)
Hospital Universitario Puerta del Mar
🇪🇸Cádiz, Andalucía, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Aragón, Spain
Hospital del Mar
🇪🇸Barcelona, Cataluña, Spain
Hospital Torrecárdenas
🇪🇸Almería, Andalucía, Spain
Hospital de Burgos
🇪🇸Burgos, Castilla Y León, Spain
Hospital Santa Lucía
🇪🇸Cartagena, Murcia, Spain
Hospital Virgen de Arrixaca
🇪🇸El Palmar, Murcia, Murcia, Spain
Hospital general de jeréz
🇪🇸Jerez de la Frontera, Andalucía, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Islas Baleares, Spain
Hospital Mutua terrassa
🇪🇸Terrassa, Cataluña, Spain
Hospital Universitario Josep Trueta de Girona
🇪🇸Girona, Cataluña, Spain
Complejo Universitario de San Carlos
🇪🇸Madrid, Spain
Hospital san pedro
🇪🇸Logroño, La Rioja, Spain
Hospital Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Clínico Universitario Valencia
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital General de Alicante
🇪🇸Alicante, Valencia, Spain
Hospital Universitario Ciudad de Jaen
🇪🇸Jaen, Andalucia, Spain
Hospital Virgen de la Nieves
🇪🇸Granada, Andalucía, Spain
Hospital General de Ciudad Real
🇪🇸Ciudad Real, Castilla La Mancha, Spain
Rio Hortega de Valladolid
🇪🇸Valladolid, Castilla Y León, Spain
Hospital La Ribera
🇪🇸Alzira, Cataluña, Spain
Hospital Duran reynls
🇪🇸Barcelona, Cataluña, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Galicia, Spain
Hospital de Insular de Gran Canaria
🇪🇸Las Palmas de Gran Canaria, Canarias, Spain
Hospital de Cabueñes
🇪🇸Gijón, Asturias, Spain
Hospital Virgen de la macarena
🇪🇸Sevilla, Andalucía, Spain
Hospital de Basurto
🇪🇸Bilbao, Castilla Y León, Spain
Hospital de León
🇪🇸León, Castilla Y León, Spain
Hospital Vall d´Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, 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 La fe
🇪🇸Valencia, Comunidad Valenciana, Spain
Complejo Hospitalario Universitario Santiago
🇪🇸Santiago de Compostela, Galicia, Spain
Hospital Fundación de Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Gregorio marañon
🇪🇸Madrid, Spain
Hospital Universitario La paz
🇪🇸Madrid, Spain
Hospital Dr peset
🇪🇸Valencia, Spain