Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment anti-myeloma treatment at physician discretion
Sponsor Celgene Corporation
Start date September 2012
End date October 2016
Trial size 326 participants
Trial identifier NCT02849444, CEL-MIE-2012-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
30 ≤ CrCl < 50 mL/min/1.73 m2
anti-myeloma treatment at physician discretion
non Interventional Study
CrCl < 30 mL/min/1.73 m2
anti-myeloma treatment at physician discretion
non Interventional Study

Primary Outcomes

Measure
Creatinine levels to determinates Renal function response
time frame: Up to 12 months
Age of participants at baseline to determinates Renal function response
time frame: Baseline visit
Weight of participants at baseline to determinates Renal function response
time frame: Baseline visit
Gender of participants at baseline to determinates Renal function response
time frame: Baseline visit

Secondary Outcomes

Measure
Race of participants at Baseline
time frame: Baseline visit
Clinical Outcome of participants with Multiple Myeloma (MM) clinical description
time frame: Up to 12 months
Renal response rate assessment in clinical practice.
time frame: Up to 12 months
Time dependent Renal response rate assessment in clinical practice.
time frame: Up to 12 months
Type of Anti-myeloma therapeutic regimens.
time frame: Up to 12 months
Multiple Myeloma (MM) response to anti-myeloma treatment
time frame: Up to 12 months
MM response to Time to Progression
time frame: Up to 12 months
MM response to Time to first response
time frame: Up to 12 months
MM response to Progression Free Survival
time frame: Up to 12 months
Adverse events (AEs)
time frame: Up to 12 months
Cost of visit to hospital/primary health care associated with anti-myeloma therapy
time frame: Up to 12 months
Number of participants with relapsed kidney function
time frame: Up to 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.