In this interactive video, Prof. Mateos gives an overview of the DARZALEX® SC PAVO, COLUMBA and PLEIADES studies. Use the video’s navigation tool to access topics of interest, including study designs, efficacy, safety, and a Q&A with Prof. Mateos, where she provides her expert opinion on the integration of DARZALEX® SC into clinical practice based on her experience from clinical trials.
DARZALEX® SC handling and administration
Handling and administration demonstration & information
DARZALEX® SC support materials
A range of materials, including a practical guide, in-clinic poster and patient materials
See how the recombinant human hyaluronidase PH20 (rHuPH20; ENHANZE® drug delivery technology) added to DARZALEX® facilitates the subcutaneous administration of the drug
PAVO is a phase 1b, open-label, multicentre, dose-finding, proof-of-concept study in RRMM patients with ≥2 prior lines of treatment who have not received anti-CD38 therapy.
In Part 1 of the study, patients received 28-day cycles of daratumumab 1,200 mg + rHuPH20 30,000 U (in 60 mL; Group 1) or daratumumab 1,800 mg + rHuPH20 45,000 U (in 90 mL; Group 2) following the approved IV monotherapy dosing schedule (QW in Cycles 1 and 2, Q2W in Cycles 3 through 6, and Q4W thereafter).
In Part 2 of the study, patients received a concentrated co-formulation of the selected daratumumab (1,800 mg) and rHuPH20 (30,000 U in 15 mL) dose in a single, pre-mixed vial.
|Slower systemic absorption with SC vs. IV|
|Maximum Ctrough is similar or higher following 1,800 mg SC compared with 16 mg/kg IV|
|Cmax at Q4W dosing – 1,800 mg SC is similar to 16 mg/kg IV overall|
|Clinical response rates similar to IV|
DARZALEX® SC was well tolerated with an AE profile consistent with DARZALEX® IV
COLUMBA is a phase 3, randomised, open-label, active-controlled, multicentre non-inferiority study of DARZALEX® SC versus DARZALEX® IV in patients with heavily pre-treated RRMM. N=522*
* After at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.
NEW DATA COLUMBA: Primary and final analysis of Part 1 of the study
*DARZALEX® SC vs. DARZALEX® IV at median follow-up of 13.7 months.
DARZALEX® SC offers a similar safety profile with fewer and less severe IRRs vs. DARZALEX® IV
Injection-site reactions (ISRs) occurred in 7% of DARZALEX® SC patients (all Grade 1/2)
PLEIADES is a phase 2, multicentre, open-label study of DARZALEX® SC in combination with standard of care. N=199
Study arms included:
Includes a first use checklist of Darzalex® SC.
Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more
AE: adverse event
ASCT: autologous stem cell transplant
ASH: American Society of Hematology
C3D1: Cycle 3 Day 1
CI: confidence interval
Cmax: maximum concentration
Ctrough: trough concentration
DRd: DARZALEX®, lenalidomide, dexamethasone
DVMP: DARZALEX®, Velcade®, melphalan, prednisone
IRR: infusion-related reaction
ISR: injection-site reaction
ITT: intention to treat
MOA: mode of action
MRD: minimal residual disease
NDMM: newly-diagnosed multiple myeloma
ORR: overall response rate
QW: every week
Q2W: every 2 weeks
Q4W: every 4 weeks
Rd: lenalidomide, dexamethasone
rHuPH20: recombinant human hyaluronidase
RRMM: relapsed/refractory multiple myeloma
PH20 RRMM: relapsed/refractory multiple myeloma
TEAE: treatment-emergent adverse event
VMP: Velcade®, melphalan, dexamethasone
Titular da Autorização de Introdução no Mercado: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Bélgica.
Para mais informações deverá contactar o Representante do Titular da Autorização de Introdução no Mercado: Janssen-Cilag Farmacêutica, Lda.
Medicamento de receita médica restrita, de utilização reservada a certos meios especializados.
Antes de prescrever consulte o RCM completo.
RCM de Darzalex®, veja aqui