Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy

PHASE3CompletedINTERVENTIONAL
Enrollment

284

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 30, 2015

Study Completion Date

December 31, 2017

Conditions
Chronic Renal Failure With Uremic Nephropathy
Interventions
DRUG

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."

DRUG

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."

DEVICE

HCO group

TheraliteTM dialyzer of 2.1 m2 in surface

DEVICE

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.

Trial Locations (1)

75010

Hôpital Saint Louis, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT01208818 - Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy | Biotech Hunter | Biotech Hunter