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DARZALEX® + Velcade® + dexamethasone (DVd)

After at least one prior therapy

DARZALEX® delivers remarkable efficacy in combination with Velcade® (bortezomib) and dexamethasone (Vd) in relapsed/refractory patients with ≥1 prior therapy*[1][2][3][4]

Highlight

Prof. María-Victoria Mateos discusses 4-year updates on the CASTOR study – DARZALEX®+ Vd in RRMM

Study design

CASTOR is a randomised, open-label, active-controlled, multicentre phase 3 study comparing DARZALEX® + Vd (DVd) vs. Vd. N=498[2]

* DVTd vs. VTd alone.

CASTOR study profile

(PDF, 5.8 MB)

Efficacy

CASTOR: Updated analysis presented at the ASH Annual Meeting 2019

Median follow-up: 50.2 months[4]

Progression-free survival

Complete response or better

MRD negativity (10-5)†

Subgroup analyses

DARZALEX® + Vd provided consistently better outcomes across pre-specified patient subgroups:[3][4][5][6]

  • High-risk cytogenetics
  • Prior lenalidomide exposure
  • One prior line

* DVd vs. Vd alone.

† MRD was assessed via next-generation sequencing on bone marrow aspirate samples that were ficolled and evaluated by the US Food and Drug Administration–approved clonoSEQ® assay V2.0 (Adaptive Biotechnologies, Seattle, WA) at sensitivity thresholds of 10-4 (1 cancer cell per 10,000 nucleated cells), 10-5, and 10-6.[3]

Safety Profile

DARZALEX® + Vd offers a manageable tolerability profile
  • No new safety concerns with longer follow-up (>4 years)[4]
  • Similar discontinuation rates between DVd and Vd[4]
  • Manageable infusion-related reactions (IRRs), with the majority occurring during the first infusion[2]

* DRd vs. Vd alone.

Dosing

DARZALEX® + Vd dosing schedule: 3-week cycle regimen[1]

Treatment

Dose

Dosing schedule

DARZALEX® (daratumumab)

1800 mg SC

Cycle 1–3: Weekly

Cycles 4–8: Every 3 weeks

Cycles 9+: Every 4 weeks until disease progression

Velcade® (bortezomib)

1.3 mg/m2 SC/IV

Cycles 1–8: Twice weekly on Weeks 1 and 2

Dexamethasone

20 mg PO†

Cycles 1–8: Days 1, 2, 4, 5, 8, 9, 11 and 12

† On DARZALEX® dosing days, the pre-administration medication replaces the daily dose of dexamethasone.

DVd dosing schedule

(PDF, xx KB)

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

CASTOR study

Summary of study design, efficacy results and safety profile for DVd in RRMM.

Glossary

ASH: American Society of Hematology 

DVd: DARZALEX®, Velcade®, dexamethasone 

IRR: infusion-related reaction

IV: intravenous 

MRD: minimal residual disease 

PO: orally

RRMM: relapsed/refractory multiple myeloma 

SC: subcutaneous 

Vd: Velcade®, dexamethasone

Para visualizar o IECRCM de Darzalex, veja aqui.

Referências

RCM DARZALEX ®. Acedido em março de 2022. Disponível em www.ema.europa.eu
Palumbo A et al. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375:754–766.
Mateos MV et al. Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) in First Relapse Patients With Multiple Myeloma (MM): Update of CASTOR. Poster presented at the 60th annual meeting of the American Society of Hematology (ASH). San Diego, CA. December 1–4, 2018. #3270.
Weisel K et al. Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) in First Relapse Patients (pts) with Multiple Myeloma (MM): Four-Year Update of CASTOR. Poster presented at the 61st annual meeting of the American Society of Hematology (ASH). Orlando, FL, December 7–10, 2019. #3192.
Spencer A et al. Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR. Haematologica. 2018;103:2079–2087.
Usmani SZ et al. Efficacy of Daratumumab in Combination with Standard of Care Regimens in Lenalidomide-Exposed or -Refractory Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Analysis of the Castor, Pollux, and MMY1001 Studies. Poster presented at the 60th annual meeting of the American Society of Hematology (ASH). San Diego, CA. December 1–4, 2018. #3288.
CP-287814 - Março 2022