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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

progression-free-survival-56pc@1x

Complete response or better

complete-response-58pc@1x.png

Progression-free survival

MRD-negativity-33pc@1x.png
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]

dosing-schedule-RR-DRd@1x.jpg

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.
CP-287814 - março 2022