Chronic Renal Failure With Uremic NephropathyPhase 3MYRENCT01208818
Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy
A Phase 3 study testing Cyclophosphamide + Bortezomib + Dexamethasone regimen, Bortezomib +Dexamethasone regimen and HCO group in people with Chronic Renal Failure With Uremic Nephropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure With Uremic Nephropathy
- What is being tested?
- Cyclophosphamide + Bortezomib + Dexamethasone regimen, Bortezomib +Dexamethasone regimen and HCO group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Dec 2017
- Phase
- Phase 3
- 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
Who may be able to join
- Age >=18 years old
- Serum creatinine > 170µmol/l and/or DFG < 40 ml/min/1.73 m2
- Myeloma cast nephropathy (MCN)
- Multiple myeloma
- Informed consent
- neutrophils >= 1 Giga/L and platelets >= 70 Giga/L
Who cannot join
- Amylosis
- Chronic renal Failure with eDFG < 30 ml/min/1.73 m2, unrelated to myeloma
- Peripheral neuropathy
- Contraindications to either corticosteroids or Bortezomib
- Patient refusal
- Known HIV infection
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- Concomitant severe disease including neoplasias (except basocellular carcinoma)
- Liver failure, cytolysis, and/or cholestasis
- Fertile women who refuse or cannot use effective contraception; Women pregnant or nursing; Women with positive test pregnancy (test before treatment initiation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane.
MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.
Read the detailed description
MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.
Study hypotheses are: (1) in patients not requiring dialysis, based on renal response after 3 cycles as the main endpoint, to show a benefit of 30% in absolute rate from an expected 30% response rate in the control arm; and (2) in patients requiring hemodialysis, using the prevalence of patients free of dialysis after 3 cycles as the main endpoint, to show a benefit of at least 20% from an assumed rate of 50% in the control arm. A total sample size of 284 patients was computed to be enrolled (type I and II error rates at 5 and 20%, respectively).
- Being tested
- Cyclophosphamide + Bortezomib + Dexamethasone regimen, Bortezomib +Dexamethasone regimen, HCO group, conventional high-flux dialyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide + Bortezomib + Dexamethasone regimenDrug
Dosing regimen (21 day-cycle):
- Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.
- Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12.
- Cyclophosphamide 900 mg/m2 on day 1, through a short I.V. infusion The regimen is given for 3 cycles in the absence of serious side-effect.
Bortezomib +Dexamethasone regimenDrug
Dosing regimen (21 day-cycle):
- Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.
- Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. The regimen is given for 3 cycles in the absence of serious side-effect.
HCO groupDevice
TheraliteTM dialyzer of 2.1 m2 in surface
conventional high-flux dialyzerDevice
conventional high-flux dialyzer; polyacrylonitrile, polysulfone, or PMMA dialysers, with an ultrafiltration coefficient > 14 ml/min and ≥ 1.8 m2 in surface, are recommended.
| Study group | Role | What they receive |
|---|---|---|
| BD | Active comparator | Not described Receives: Drug: Bortezomib +Dexamethasone regimen |
| C-BD | Experimental | Not described Receives: Drug: Cyclophosphamide + Bortezomib + Dexamethasone regimen |
| HCO | Experimental | Not described Receives: Drug: Bortezomib +Dexamethasone regimen; Device: HCO group |
| Control HD | Active comparator | Not described Receives: Drug: Bortezomib +Dexamethasone regimen; Device: conventional high-flux dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of renal response (if dialysis not mandatory at baseline: strata 1); Prevalence of patients free of dialysis (if dialysis required at baseline; strata 2)
- renal response is defined by creatinine≤ 170 µmol/l and/or DFG (modified MDRD) ≥ 40 ml/min/1.73m2
- the absence of any dialysis requirement will be defined by an eDFG > 15 ml/min/1.73 m2, 15 days after the last hemodialysis session
Measured: 3 months after randomization
Secondary outcomes (5)
Improvement in renal function
- DFG (modified MDRD)
- hemodialysis requirement
Measured: after 1 cycle of chemotherapy, at the end of chemotherapy, at 6 months and 1 year
Hematological response
Partial Response (PR) Very Good Partial Response (VGPR) Complete Response (CR)
Measured: after 1 and 3 courses, at the end of chemotherapy and at 1 year
Progression free survival (PFS)
Time to progression, relapse or death from randomization
Measured: 4 years
Time to treatment Failure (TTF)
Time from randomization to progression, relapse, non scheduled hematological treatment or death
Measured: 4 years
Overall survival (OS)
Time to death from randomization
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startJun 2011
- Primary completionSep 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal Failure With Uremic NephropathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Fermand, MD, Principal investigator, Hôpital saint Louis, Paris, FranceFranck Bridoux, MD, PhD, Study director, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208818
- Sponsor's protocol ID
- P081226
- Acronym
- MYRE
- Status last verified
- Dec 2017
- First submitted
- 23 Sep 2010
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bridoux F, Carron PL, Pegourie B, Alamartine E, Augeul-Meunier K, Karras A, Joly B, Peraldi MN, Arnulf B, Vigneau C, Lamy T, Wynckel A, Kolb B, Royer B, Rabot N, Benboubker L, Combe C, Jaccard A, Moulin B, Knebelmann B, Chevret S, Fermand JP; MYRE Study Group. Effect of High-Cutoff Hemodialysis vs Conventional Hemodialysis on Hemodialysis Independence Among Patients With Myeloma Cast Nephropathy: A Randomized Clinical Trial. JAMA. 2017 Dec 5;318(21):2099-2110. doi: 10.1001/jama.2017.17924.
PubMed 29209721
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane.
- ClinicalTrials.gov ID
- NCT01208818
- Acronym / sponsor ID
- MYRE / P081226
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Sep 2010 (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.
MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.
Detailed description
MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.
Study hypotheses are: (1) in patients not requiring dialysis, based on renal response after 3 cycles as the main endpoint, to show a benefit of 30% in absolute rate from an expected 30% response rate in the control arm; and (2) in patients requiring hemodialysis, using the prevalence of patients free of dialysis after 3 cycles as the main endpoint, to show a benefit of at least 20% from an assumed rate of 50% in the control arm. A total sample size of 284 patients was computed to be enrolled (type I and II error rates at 5 and 20%, respectively).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BD | Active comparator | Drug: Bortezomib +Dexamethasone regimen |
| C-BD | Experimental | Drug: Cyclophosphamide + Bortezomib + Dexamethasone regimen |
| HCO | Experimental | Drug: Bortezomib +Dexamethasone regimen, Device: HCO group |
| Control HD | Active comparator | Drug: Bortezomib +Dexamethasone regimen, Device: conventional high-flux dialyzer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >=18 years old
- Serum creatinine > 170µmol/l and/or DFG < 40 ml/min/1.73 m2
- Myeloma cast nephropathy (MCN)
- Multiple myeloma
- Informed consent
Key exclusion criteria (9 listed)
- Amylosis
- Chronic renal Failure with eDFG < 30 ml/min/1.73 m2, unrelated to myeloma
- Peripheral neuropathy
- Contraindications to either corticosteroids or Bortezomib
- Patient refusal
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 |
|---|---|---|
| Cyclophosphamide + Bortezomib + Dexamethasone regimenDosing regimen (21 day-cycle): * Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required. * Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. * Cyclophosphamide 900 mg/m2 on day 1, through a short I.V. infusion The regimen is given for 3 cycles in the absence of serious side-effect. | Drug | C-BD |
| Bortezomib +Dexamethasone regimenDosing regimen (21 day-cycle): * Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required. * Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. The regimen is given for 3 cycles in the absence of serious side-effect. | Drug | BD, Control HD, HCO |
| HCO groupTheraliteTM dialyzer of 2.1 m2 in surface | Device | HCO |
| conventional high-flux dialyzerconventional high-flux dialyzer; polyacrylonitrile, polysulfone, or PMMA dialysers, with an ultrafiltration coefficient > 14 ml/min and ≥ 1.8 m2 in surface, are recommended. | Device | Control HD |
Primary outcome
Prevalence of renal response (if dialysis not mandatory at baseline: strata 1); Prevalence of patients free of dialysis (if dialysis required at baseline; strata 2)
Time frame: 3 months after randomization
* renal response is defined by creatinine≤ 170 µmol/l and/or DFG (modified MDRD) ≥ 40 ml/min/1.73m2 * the absence of any dialysis requirement will be defined by an eDFG > 15 ml/min/1.73 m2, 15 days after the last hemodialysis session
5 secondary outcomes
Improvement in renal function
Time frame: after 1 cycle of chemotherapy, at the end of chemotherapy, at 6 months and 1 year
Hematological response
Time frame: after 1 and 3 courses, at the end of chemotherapy and at 1 year
Progression free survival (PFS)
Time frame: 4 years
Time to treatment Failure (TTF)
Time frame: 4 years
Overall survival (OS)
Time frame: 4 years
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 8 Dec 2017.
- Derived from this study: PubMed 29209721Bridoux F, Carron PL, Pegourie B, Alamartine E, Augeul-Meunier K, Karras A, Joly B, Peraldi MN, Arnulf B, Vigneau C, Lamy T, Wynckel A, Kolb B, Royer B, Rabot N, Benboubker L, Combe C, Jaccard A, Moulin B, Knebelmann B, Chevret S, Fermand JP; MYRE Study Group. Effect of High-Cutoff Hemodialysis vs Conventional Hemodialysis on Hemodialysis Independence Among Patients With Myeloma Cast Nephropathy: A Randomized Clinical Trial. JAMA. 2017 Dec 5;318(21):2099-2110. doi: 10.1001/jama.2017.17924.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Paul Fermand, MD principal investigator
Hôpital saint Louis, Paris, France
Franck Bridoux, MD, PhD study director
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide + Bortezomib + Dexamethasone regimen, Bortezomib +Dexamethasone regimen and HCO group in people with Chronic Renal Failure With Uremic Nephropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 9 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prevalence of renal response (if dialysis not mandatory at baseline: strata 1); Prevalence of patients free of dialysis (if dialysis required at baseline; strata 2) (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01208818, which also lists 1 linked publication.
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 8 Dec 2017.