Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy
NCT ID: NCT01208818
Last Updated: 2017-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
284 participants
INTERVENTIONAL
2011-06-30
2017-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BD
Bortezomib +Dexamethasone regimen
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.
C-BD
Cyclophosphamide + Bortezomib + Dexamethasone regimen
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.
HCO
Bortezomib +Dexamethasone regimen
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 group
TheraliteTM dialyzer of 2.1 m2 in surface
Control HD
Bortezomib +Dexamethasone regimen
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.
conventional high-flux dialyzer
conventional high-flux dialyzer; polyacrylonitrile, polysulfone, or PMMA dialysers, with an ultrafiltration coefficient \> 14 ml/min and ≥ 1.8 m2 in surface, are recommended.
Interventions
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Cyclophosphamide + Bortezomib + Dexamethasone regimen
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 regimen
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 group
TheraliteTM dialyzer of 2.1 m2 in surface
conventional high-flux dialyzer
conventional high-flux dialyzer; polyacrylonitrile, polysulfone, or PMMA dialysers, with an ultrafiltration coefficient \> 14 ml/min and ≥ 1.8 m2 in surface, are recommended.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Paul Fermand, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital saint Louis, Paris, France
Franck Bridoux, MD, PhD
Role: STUDY_DIRECTOR
CHU Poitiers
Locations
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Hôpital Saint Louis
Paris, , France
Countries
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References
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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.
Other Identifiers
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P081226
Identifier Type: -
Identifier Source: org_study_id