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DARZALEX® + lenalidomide + dexamethasone (DRd)
Transplant-ineligible
DARZALEX® delivers remarkable efficacy in combination with lenalidomide and dexamethasone*[1]
Highlight — 2020 update
Thierry Facon, of Lille University Hospital, dicusses the first results from MAIA study.
Study design
MAIA is a randomised, open-label, active-controlled, multicentre phase 3 study comparing DRd with Rd alone in newly-diagnosed transplant-ineligible patients with MM. N=737[2]
* DVTd vs. VTd alone.
MAIA study profile
(PDF, 5.8 MB)
Page contents
Efficacy
NEW DATA | MAIA: Updated analysis presented at the EHA 2021[1]
Median follow-up: 56.2 months[1]
Progression-free survival
Overall survival
Complete response or better
MRD negativity (10-5)†
Further efficacy results[1]
- DARZALEX® + Rd provided generally consistent OS benefit across pre-specified patient subgroups[1]
- The progression-free survival and overall survival benefits were maintained among the 44% of patients who were ≥75 years of age[1]
- MRD-negative patients experienced longer progression-free survival compared with those who were MRD positive[2]
* DRd vs. Rd alone.
†At 10-5 sensitivity threshold compared with Rd alone (p<0.0001).
ǂ Follow-up at 47.9 months
Safety Profile
DARZALEX® + Rd offers a predictable and manageable tolerability profile despite the elderly population[1]
- 44% of patients in the study were aged ≥75 years[1]
- No new safety concerns occurred even with almost five years of continuous therapy and follow-up[1]
- Lower discontinuation rates due to AEs for DRd vs. Rd[1]
- IRRs were usually Grade 1–2, and the vast majority occurred during the first infusion[3]
* DRd vs. Rd alone.
Dosing
DARZALEX® + Rd dosing schedule: 4-week cycle regimen[4]
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) | 1800 mg SC | Cycle 1–2: Weekly Cycles 3–4: Every 2 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 IV/PO | Once weekly or a reduced dose of 20 mg/m2 week for patients >75 years or BMI <18.5 kg/m2 |
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
MAIA study
Summary of study design, efficacy results and safety profile for DRd in transplant-ineligible NDMM.
Glossary
AE: adverse event
ASH: American Society of Hematology
DRd: DARZALEX®, lenalidomide, dexamethasone
IRR: infusion-related reaction
IV: intravenous
MM: multiple myeloma
MRD: minimal residual disease
NDMM: newly-diagnosed multiple myeloma
PO: oral
Rd: lenalidomide, dexamethasone
SC: subcutaneous
