Multiple MyelomaMIR50NCT02849444
A Study to Assess Renal Function Response to Treatment in Patients With Relapsed Multiple Myeloma and Creatinine Clearance
An observational study of Multiple Myeloma, run by Celgene at 40 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Anti-myeloma treatment at physician discretion
- How many people
- 326 participants
- Where
- 40 sitesSpain
- Study dates
- 23 Sep 2012to 10 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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):
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Spain40 sites
Hospital Fundación de Alcorcón
Alcorcón, Madrid, 28922
Hospital General de Alicante
Alicante, Valencia, 03010
Hospital Torrecárdenas
Almería, Andalusia, 04009
Hospital La Ribera
Alzira, Catalonia, 46600
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Vall d´Hebron
Barcelona, Catalonia, 08035
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalonia, 08208
Hospital Duran reynls
Barcelona, Catalonia, 08907
Hospital de Basurto
Bilbao, Castille and León, 48013
Hospital de Burgos
Burgos, Castille and León, 09007
Hospital Universitario Puerta del Mar
Cadiz, Andalusia, 11009
Hospital Santa Lucía
Cartagena, Murcia, 30202
Hospital General de Ciudad Real
Ciudad Real, Castille-La Mancha, 13005
Hospital Virgen de Arrixaca
El Palmar, Murcia, Murcia, 30120
Hospital de Cabueñes
Gijón, Principality of Asturias, 33394
Hospital Universitario Josep Trueta de Girona
Girona, Catalonia, 17007
Hospital Virgen de la Nieves
Granada, Andalusia, 18014
Hospital Universitario Ciudad de Jaen
Jaén, Andalusia, 23007
Hospital general de jeréz
Jerez de la Frontera, Andalusia, 11407
Hospital de Insular de Gran Canaria
Las Palmas de Gran Canaria, Canary Islands, 35010
Hospital de León
León, Castille and León, 24001
Hospital Arnau de Vilanova de Lleida
Lleida, Catalonia, 25198
Hospital san pedro
Logroño, La Rioja, 26006
Hospital Gregorio marañon
Madrid, 28007
Hospital Ramon y Cajal
Madrid, 28034
Complejo Universitario de San Carlos
Madrid, 28040
Hospital Universitario La paz
Madrid, 28046
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Sant Joan de manresa
Manresa, Catalonia, 08243
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital de Sabadell ( Parc Taulí)
Sabadell, Catalonia, 08208
Complejo Hospitalario Universitario Santiago
Santiago de Compostela, Galicia, 15006
Hospital Virgen de la macarena
Seville, Andalusia, 41071
Hospital Mutua terrassa
Terrassa, Catalonia, 08221
Hospital Clínico Universitario Valencia
Valencia, Valencia, 46010
Hospital La fe
Valencia, Valencia, 46026
Hospital Dr peset
Valencia, 46017
Rio Hortega de Valladolid
Valladolid, Castille and León, 47003
Complejo Hospitalario Universitario de Vigo
Vigo, Galicia, 36036
Hospital Miguel Servet
Zaragoza, Aragon, 50009
About this study
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)
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Anti-myeloma treatment at physician discretion
- Keywords
- renal function, Relapsed Multiple myeloma, anti-MM therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-myeloma treatment at physician discretionOther
non Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Moderate kidney failure | 30 ≤ CrCl < 50 mL/min/1.73 m2 Receives: Other: Anti-myeloma treatment at physician discretion | |
| Severe kidney failure | CrCl < 30 mL/min/1.73 m2 Receives: Other: Anti-myeloma treatment at physician discretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine levels to determinates Renal function response
Creatinine records from basal visit to last visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
Measured: Up to 12 months
Age of participants at baseline to determinates Renal function response
Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.
Measured: Baseline visit
Weight of participants at baseline to determinates Renal function response
Patient weight recorded in each visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
Measured: Baseline visit
Gender of participants at baseline to determinates Renal function response
Patient gender recorded in basal visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
Measured: Baseline visit
Secondary outcomes (12)
Race of participants at Baseline
To describe the demographic characteristics of patients with relapsed multiple myeloma and CrCl <50 mL/min/1.73 m2.
Measured: Baseline visit
Clinical Outcome of participants with Multiple Myeloma (MM) clinical description
To describe the clinical characteristics of patients with relapsed multiple myeloma and CrCl <50 mL/min/1.73 m2.
Measured: Up to 12 months
Renal response rate assessment in clinical practice.
Describe response rate of renal function according to eGFR and total proteinuria
Measured: Up to 12 months
Time dependent Renal response rate assessment in clinical practice.
Time to best renal response
Measured: Up to 12 months
Type of Anti-myeloma therapeutic regimens.
Describe various types of anti-myeloma regimens participants will receive.
Measured: Up to 12 months
Multiple Myeloma (MM) response to anti-myeloma treatment
MM response evaluation according to IMWG criteria
Measured: Up to 12 months
MM response to Time to Progression
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.
Measured: Up to 12 months
MM response to Time to first response
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.
Measured: Up to 12 months
MM response to Progression Free Survival
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.
Measured: Up to 12 months
Adverse events (AEs)
Number of participants with adverse events
Measured: Up to 12 months
Cost of visit to hospital/primary health care associated with anti-myeloma therapy
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.
Measured: Up to 12 months
Number of participants with relapsed kidney function
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.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start23 Sep 2012
- Primary completion23 Dec 2019
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mireya Navarro, MD, Study director, Celgene Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849444
- Sponsor's protocol ID
- CEL-MIE-2012-01
- Acronym
- MIR50
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2015
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02849444
- Acronym / sponsor ID
- MIR50 / CEL-MIE-2012-01
- Conditions
- Multiple Myeloma
- Keywords
- renal function, Relapsed Multiple myeloma, anti-MM therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2012 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate kidney failure | – | Other: Anti-myeloma treatment at physician discretion30 ≤ CrCl < 50 mL/min/1.73 m2 |
| Severe kidney failure | – | Other: Anti-myeloma treatment at physician discretionCrCl < 30 mL/min/1.73 m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (3 listed)
- 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 *.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-myeloma treatment at physician discretionnon Interventional Study | Other | Moderate kidney failure, Severe kidney failure |
Primary outcome
Creatinine levels to determinates Renal function response
Time frame: 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
Time frame: Baseline visit
Patient Age record to determinates Creatinine clearance with the Cockcroft-Gault formula.
Weight of participants at baseline to determinates Renal function response
Time frame: 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
Time frame: Baseline visit
Patient gender recorded in basal visit to determinates Creatinine clearance with the Cockcroft-Gault formula.
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireya Navarro, MD study director
Celgene Spain
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Celgene at 40 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinine levels to determinates Renal function response (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.