NCT01985126: Phase 2 - Dara in MM who had 3 prior lines inc. PI, Imid - or db. ref. MMY2002 (SIRIUS)

MMY2002 (SIRIUS) Study

An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are double refractory to a PI and an IMiD.

Multiple Locations

International Study

ClinicalTrials.gov Identifier: NCT01985126

Official Title: An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or Are Double Refractory to a Proteasome Inhibitor and an IMiD

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Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information

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Publications:

Daratumumab monotherapy in patients with heavily pretreat ed relapsed or refractory multiple myeloma:

final results from the phase 2 GEN501 and SIRIUS trials.

Lancet Haematol. 2020 Jun;7

CD38 expression and complement inhibitors affect response and resistance to daratumumab therapy in myeloma.

Blood. 2016 Aug 18

Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial.

Lancet. 2016 Apr 9

Sirius Oral Presentation : 2015 ASCO Annual Meeting