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Lenalidomide PK in Multiple Myeloma with Renal Impairment
NCT00779922Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2008
- Primary completion
- Sep 2012
- Countries
- 1
- Sponsor
- CHU de Poitiers
- Modality
- Small Molecules
- Drugs
- lenalidomide
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, open-label, single-arm trial of lenalidomide in multiple myeloma (MM), sponsored by CHU de Poitiers. Primary endpoint: Pharmacokinetic profile of Revlimid. Started Nov 2008; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Lenalidomide + Dexamethasone
Patients with varying degrees of renal impairment receiving Lenalidomide and Dexamethasone
03
Who it enrols
Adult patients with relapsed or refractory multiple myeloma and stable renal function, excluding those with amyloidosis or prior Revlimid use.
04
Endpoints
Primary
Pharmacokinetic profile of Revlimid
Secondary
Safety of Revlimid
Efficacy of Revlimid-Dexamethasone combination
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