Clinical trial NCT02849444: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: renal function
Relapsed Multiple myeloma
anti-MM therapy
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed /refractorymultiple 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.

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 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
   * 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.

Primary outcomes:
measure: Creatinine levels to determinates Renal function response
timeFrame: Up to 12 months
measure: Age of participants at baseline to determinates Renal function response
timeFrame: Baseline visit
measure: Weight of participants at baseline to determinates Renal function response
timeFrame: Baseline visit
measure: Gender of participants at baseline to determinates Renal function response
timeFrame: Baseline visit
Secondary outcomes:
measure: Race of participants at Baseline
timeFrame: Baseline visit
measure: Clinical Outcome of participants with Multiple Myeloma (MM) clinical description
timeFrame: Up to 12 months
measure: Renal response rate assessment in clinical practice.
timeFrame: Up to 12 months
measure: Time dependent Renal response rate assessment in clinical practice.
timeFrame: Up to 12 months
measure: Type of Anti-myeloma therapeutic regimens.
timeFrame: Up to 12 months
measure: Multiple Myeloma (MM) response to anti-myeloma treatment
timeFrame: Up to 12 months
measure: MM response to Time to Progression
timeFrame: Up to 12 months
measure: MM response to Time to first response
timeFrame: Up to 12 months
measure: MM response to Progression Free Survival
timeFrame: Up to 12 months
measure: Adverse events (AEs)
timeFrame: Up to 12 months
measure: Cost of visit to hospital/primary health care associated with anti-myeloma therapy
timeFrame: Up to 12 months
measure: Number of participants with relapsed kidney function
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Jaen
country: Spain
facility: Hospital Universitario Ciudad de Jaen
state: Andalucia
city: Almería
country: Spain
facility: Hospital Torrecárdenas
state: Andalucía
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
state: Andalucía
city: Granada
country: Spain
facility: Hospital Virgen de la Nieves
state: Andalucía
city: Jerez de la Frontera
country: Spain
facility: Hospital general de jeréz
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Virgen de la macarena
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
state: Aragón
city: Gijón
country: Spain
facility: Hospital de Cabueñes
state: Asturias
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital de Insular de Gran Canaria
state: Canarias
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
state: Castilla La Mancha
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Castilla Y León
city: Burgos
country: Spain
facility: Hospital de Burgos
state: Castilla Y León
city: León
country: Spain
facility: Hospital de León
state: Castilla Y León
city: Valladolid
country: Spain
facility: Rio Hortega de Valladolid
state: Castilla Y León
city: Alzira
country: Spain
facility: Hospital La Ribera
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Duran reynls
state: Cataluña
city: Girona
country: Spain
facility: Hospital Universitario Josep Trueta de Girona
state: Cataluña
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova de Lleida
state: Cataluña
city: Manresa
country: Spain
facility: Hospital Sant Joan de manresa
state: Cataluña
city: Sabadell
country: Spain
facility: Hospital de Sabadell ( Parc Taulí)
state: Cataluña
city: Terrassa
country: Spain
facility: Hospital Mutua terrassa
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Clínico Universitario Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital La fe
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario Santiago
state: Galicia
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Galicia
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Logroño
country: Spain
facility: Hospital san pedro
state: La Rioja
city: Alcorcón
country: Spain
facility: Hospital Fundación de Alcorcón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Cartagena
country: Spain
facility: Hospital Santa Lucía
state: Murcia
city: El Palmar, Murcia
country: Spain
facility: Hospital Virgen de Arrixaca
state: Murcia
city: Alicante
country: Spain
facility: Hospital General de Alicante
state: Valencia
city: Madrid
country: Spain
facility: Hospital Gregorio marañon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Complejo Universitario de San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La paz
city: Valencia
country: Spain
facility: Hospital Dr peset
Study officials:
affiliation: Celgene Spain
name: Mireya Navarro, MD
role: STUDY_DIRECTOR
References: