DARZALEX® + Revlimid® (lenalidomide) + dexamethasone
For a strong start to their treatment journey
MAIA study design: The open-label, randomized, phase 3 study compared treatment with DARZALEX® + lenalidomide + dexamethasone (DRd) (n=368) to Rd (n=369) in adult patients with newly diagnosed, transplant-ineligible MM. Treatment was continued until disease progression or unacceptable toxicity. The primary efficacy endpoint was PFS. See CLINICAL STUDIES (14.1) section of the full Prescribing Information for more information.
MAIA study results
Median PFS still not reached with DARZALEX® + Rd after 28 months of follow-up† vs 31.9 months for Rd alone1,2
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; MM=multiple myeloma.
- At 30 months: 70.6% of patients had not progressed with DRd vs 55.6% of patients in the Rd group (DRd: 95% CI, 65.0–75.4; Rd: 95% CI, 49.5–61.3)2
93% ORR was achieved with DARZALEX® + Rd1§
CR=complete response; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
∥sCR is CR plus normal free light chain ratio and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.2
DRd led to deep and durable responses1
DRd nearly doubled the number of patients who achieved CR or better vs Rd alone1
- DRd more than doubled sCR: 30% with DRd vs 13% with Rd alone1
Median duration of response has not yet been reached with DRd vs 34.7 months (95% CI: 30.8, not estimable) for Rd alone1
MRD negativity rates¶ more than tripled with DARZALEX® + Rd vs Rd alone (P<0.0001)1
- 24% of patients were MRD negative with DRd (95% CI: 19.9%, 28.9%)
- 7% of patients were MRD negative with Rd (95% CI: 4.9%, 10.5%)
MRD=minimal residual disease.
¶MRD negativity was defined as undetectable levels of multiple myeloma cells by bone marrow aspirate at any time point after the randomization and before disease progression or start of subsequent therapy, and in the trial was assessed by means of next-generation sequencing assay at a sensitivity threshold of 10-5 via bone marrow aspirate, collected at initial trial screening, at the time of confirmation of CR or sCR, and thereafter at 12, 18, 24, and 30 months.2
DARZALEX® has a demonstrated safety profile1
- The most frequent (≥20%) adverse reactions were infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, upper respiratory tract infection, bronchitis, pneumonia, decreased appetite, muscle spasms, peripheral sensory neuropathy, dyspnea, and cough
- Serious adverse reactions with a 2% greater incidence in the DRd arm compared to the Rd arm were pneumonia (DRd 15% vs Rd 8%), bronchitis (DRd 4% vs Rd 2%) and dehydration (DRd 2% vs Rd <1%)
Download a guide describing the new approval
for DARZALEX® in combination with Revlimid® (lenalidomide) and dexamethasone for adult patients with newly diagnosed, transplant-ineligible multiple myeloma