Completed
- Dec 19, 2013

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

Updated: Mar 28, 2022

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

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information

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