SIRIUS Trial: DARZALEX® as a Monotherapy

For patients with 3rd-line+ multiple myeloma after a PI and an immunomodulatory agent




DARZALEX® (daratumumab)

A phase 2, single-arm trial in heavily pretreated patients1,2

All patients received prior treatment with a proteasome inhibitor (PI) and an immunomodulatory agent1,2

DARZALEX® (daratumumab) study design

Prior Therapy

Patients were refractory to prior therapies1,2*

  • 97% to the last line of treatment
  • 95% to both a PI and an immunomodulatory agent
  • 90% to bortezomib
  • 88% to lenalidomide
  • 77% to alkylating agents
*Please note that this is not a full list of prior therapies.


Open-label, single-arm, multicenter, phase 2 international study1,2


ECOG=Eastern Cooperative Oncology Group.
  • This trial included 106 patients with relapsed or refractory multiple myeloma who were administered pre- and post-infusion medications and treated with 16 mg/kg DARZALEX® until unacceptable toxicity or disease progression1

Daratumumab (DARZALEX®) monotherapy is listed as a National Comprehensive Cancer Network® (NCCN®) Category 2A therapeutic option for patients with previously treated multiple myeloma

DARZALEX® is indicated as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Category 2A: Based on lower-level evidence, there is uniform NCCN® consensus that the intervention is appropriate.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed January 4, 2020. To view the most recent and complete version of the guideline, go online to The NCCN Guidelines® are a work in progress that may be refined as often as new significant data beomes available. The NCCN Guidelines® are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their applications or use in any way.