Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0385
Source ID: NCT01208818
Associated Drug: Cyclophosphamide + Bortezomib + Dexamethasone Regimen
Title: Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy
Acronym: MYRE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Renal Failure With Uremic Nephropathy
Interventions: DRUG: Cyclophosphamide + Bortezomib + Dexamethasone regimen|DRUG: Bortezomib +Dexamethasone regimen|DEVICE: HCO group|DEVICE: conventional high-flux dialyzer
Outcome Measures: Primary: 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, 3 months after randomization | Secondary: Improvement in renal function, * DFG (modified MDRD) * hemodialysis requirement, 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), 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, 4 years|Time to treatment Failure (TTF), Time from randomization to progression, relapse, non scheduled hematological treatment or death, 4 years|Overall survival (OS), Time to death from randomization, 4 years
Sponsor/Collaborators: Sponsor: Assistance Publique - Hôpitaux de Paris
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 284
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2017-12
Results First Posted:
Last Update Posted: 2017-12-08
Locations: Hôpital Saint Louis, Paris, 75010, France
URL: https://clinicaltrials.gov/show/NCT01208818