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