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NCT00574288: Phase 1/2: Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma - GEN501 study

Updated: Mar 28, 2022

GEN501 study


Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma

Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.

Multiple Locations

International Study Identifier: NCT00574288

Official Title: Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma - Open Label, Dose-escalation Followed by Open Label, Single-arm Study


Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information



Daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma: final results from the phase 2 GEN501 and SIRIUS trials.

Lancet Haematol. 2020 Jun;7

Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma.

N Engl J Med. 2015 Sep 24

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