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DARZALEX® + lenalidomide + dexamethasone (DRd)

After at least one prior therapy

DARZALEX® delivers remarkable efficacy in combination with lenalidomide and dexamethasone (Rd) in relapsed/refractory patients with ≥1 prior therapy*[1][2][3][4][5][6]

Highlight

Prof. María-Victoria Mateos presents 4-year follow-up data for DARZALEX® + Rd in relapsed/refractory multiple myeloma (POLLUX TRIAL)

Study design

POLLUX is a randomised, open-label, active-controlled, multicentre phase 3 study comparing DARZALEX® + Rd (DRd) vs. Rd. N=569[2]

* DVTd vs. VTd alone.

POLLUX study profile

(PDF, 5.8 MB)

Efficacy

POLLUX: Updated analysis presented at the ASH Annual Meeting 2019

Median follow-up: 54.8 months[3]

Progression-free survival

Complete response or better

Progression-free survival

Subgroup analyses

DARZALEX® + Rd provided consistently better outcomes across pre-specified patient subgroups[2][3][5][6]

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

* DRd vs. Rd alone.

† MRD testing was performed on ficolled bone marrow aspirate samples via the clonoSEQ® assay V2.0 (Adaptive Biotechnologies, Seattle, WA) at a sensitivity threshold of 10-5 (1 cancer cell per 100,000 nucleated cells).[4]

Safety Profile

DARZALEX® + Rd offers a manageable tolerability profile
  • Consistent safety profile with known tolerability of regimen components[2]
  • Discontinuation rates were similar for DRd and Rd[3]
  • IRRs were usually Grade 1–2, and the majority occurred during the first infusion[2]
  • No new safety concerns were identified with longer follow-up (>4 years)[3]

* DRd vs. Rd alone.

Dosing

DARZALEX® + Rd dosing schedule: 4-week cycle regimen[1]

Treatment

Dose

Dosing schedule

DARZALEX® (daratumumab)

1800 mg SC

Cycle 1–2: Weekly

Cycles 3–6: Every 3 weeks

Cycles 7+: Every 4 weeks until disease progression

Lenalidomide

25 mg PO

Once daily on Days 1–21 of each cycle until disease progression

Dexamethasone

40 mg PO/IV†

Every week until disease progression

† On daratumumab infusion days, 20 mg of the dexamethasone dose was given as a pre-infusion medication and the remainder given the day after the infusion.[1]

DRd 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

POLLUX study

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

Glossary

DRd: DARZALEX®, lenalidomide, dexamethasone

IRR: infusion-related reaction

IV: intravenous

MRD: minimal residual disease 

NR: not reached 

PO: oral

Rd: lenalidomide, dexamethasone 

RRMM: relapsed/refractory multiple myeloma 

SC: subcutaneous

Para visualizar o IECRCM de Darzalex, veja aqui.

Referências

RCM DARZALEX ®. Acedido em março de 2022. Disponível em www.ema.europa.eu
Dimopoulos MA et al. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375:1319–1331.
Kaufman JL et al. Four-Year Follow-up of the Phase 3 Pollux Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) Alone in Relapsed or Refractory Multiple Myeloma (RRMMPoster presented at the 61st annual meeting of the American Society of Hematology (ASH). Orlando, FL, December 7–10, 2019. #1866.
Bahlis NJ et al. Three-year Follow-up of the Phase 3 POLLUX Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) Alone in Relapsed or Refractory Multiple Myeloma (RRMM). Poster presented at the 60th annual meeting of the American Society of Hematology (ASH). San Diego, CA. December, 1–4, 2018. #1996.
Dimopoulos MA et al. Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX. Haematologica. 2018;103:2088–2096.
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