Last updated on March 2018

Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment

Brief description of study

This study will evaluate the effects of Daratumumab with dexamethasone in subjects with relapsed or refractory multiple myeloma and renal impairment.

Detailed Study Description

This is a multicenter, single arm, open-label phase 2 study. Approximately 38 subjects will be enrolled to receive daratumumab + dexamethasone. Treatment cycles have duration of 28 days. Subjects will receive treatment until disease progression, death, unacceptable toxicity or for a maximum of 30 months. Drug administration and follow-up visits will occur more frequently for early cycles (weekly for the first 8 weeks, every two weeks for weeks 9-24 and then every 4 weeks). Disease evaluations will occur monthly and will involve mainly measurements of myeloma proteins. Other assessments may include bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin, and 2- microglobulin and albumin.

Clinical Study Identifier: NCT03450057

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