DARZALEX® monotherapy

Heavily pre-treated

DARZALEX® monotherapy delivers remarkable efficacy in heavily pre-treated and highly refractory patients[1][2][3]

Study design

DARZALEX® has been studied in two single-arm, phase 1/2 and phase 2 trials, GEN501 and SIRIUS[4][5]


GEN501/SIRIUS: Updated analysis presented at the ASH Annual Meeting 2017

Median follow-up: 36.6 months[3]

Overall survival

Overall response rate

≥ Very good partial response rate

Combined analysis of GEN501 and SIRIUS populations

Safety Profile

DARZALEX® monotherapy offers a manageable tolerability profile[2][3]
  • Only 6 (4.1%) patients in total discontinued the study due to adverse events[2]
  • Manageable infusion-related reactions (IRRs), and caused no discontinuations to treatment[2][6]


DARZALEX® monotherapy dosing schedule: 4-week cycle regimen[1][2]



Dosing schedule

DARZALEX® (daratumumab)

1800 mg SC

Cycles 1–2: Days 1, 8, 15, 22

Cycles 3–6: Days 1, 15

Cycles 7+: Every 4 weeks until disease progression

Monotherapy dosing schedule

(PDF, xx KB)

EHA 2019 update[7]

Results of the DARZALEX® monotherapy early access treatment protocol in patients from Europe and Russia with RRMM

  • A total of 293 heavily pre-treated RRMM patients (Spain, Italy, Russia and United Kingdom) were given early access to DARZALEX® monotherapy 
  • Pooled analysis confirmed the tolerability safety profile and efficacy of DARZALEX® monotherapy 
  • No new safety concerns were identified, and HRQoL was maintained

Quick downloads

SC Checklist beginning of treatment

Includes a first use checklist of Darzalex® SC.

Darzalex® SC Practical Guide

Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more


ASH: American Society of Hematology 

EHA: European Hematology Association 

HRQoL: health-related quality of life

IRR: infusion-related reaction 

IV: intravenous

RRMM: relapsed/refractory multiple myeloma 

SC: subcutaneous

Para visualizar o IECRCM de Darzalex, veja aqui.


RCM DARZALEX ®. Acedido em março de 2022. Disponível em www.ema.europa.eu
Usmani SZ et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood. 2016;128;37–44.
Usmani SZ et al. Safety and Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed and Refractory Multiple Myeloma: Final Results from GEN501 and Sirius. Poster presented at the 59th annual meeting of the American Society of Hematology (ASH). Atlanta, GA. December 9–12, 2017. #3107.
Lokhorst HM et al. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma N Engl J Med. 2015;373:1207–1219.
Lonial S et al. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016;387:1554–1560.
Usmani SZ et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood. 2016;128;37–44. Supplementary appendix.
Cook G et al. Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients From Europe and Russia With Relapsed or Refractory Multiple Myeloma. Poster presented at the 24th European Hematology Association (EHA) annual congress. Amsterdam, the Netherlands. June 13–16, 2019. #PS1425.
CP-287814 - Março 2022