Status:
COMPLETED
Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Chronic Renal Failure With Uremic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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) ...
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) ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT01208818
Start Date
June 1 2011
End Date
December 1 2017
Last Update
December 8 2017
Active Locations (1)
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1
Hôpital Saint Louis
Paris, France, 75010