Results of an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma.

ABSTRACT:

Background

Daratumumab is a human CD38-directed monoclonal antibody indicated for the treatment of relapsed and refractory multiple myeloma (MM).

Methods

A multicenter, open-label treatment protocol provided early access to daratumumab for patients who had progressive MM after they received ≥3 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent or if they were refractory to both a proteasome inhibitor and an immunomodulatory agent. Patients received daratumumab 16 mg/kg weekly for 8 weeks, every other week for 16 weeks, and monthly until they developed disease progression, unacceptable toxicity, or 60 days after the drug gained US approval. Treatment-emergent grade ≥3 adverse events (AEs), serious AEs, and AEs of special interest were co

SUBMITTER: Chari A 

PROVIDER: S-EPMC6587745 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature