MAIA Study Design
Continuous DARZALEX® + Rd in MAIA: A Proven Frontline Treatment1
The MAIA Study1,2
Study design: MAIA, a phase 3 global, open-label, randomized, multicenter, active-controlled trial, compared treatment with DRd (n=368) to treatment with Rd (n=369) in transplant-ineligible adult patients with newly diagnosed multiple myeloma. Treatment was continued in both arms until disease progression or unacceptable toxicity. The baseline demographic and disease characteristics were similar between the 2 treatment groups. The median age was 73 years (range: 45-90 years), with 44% of the patients ≥75 years of age.
In the MAIA trial, DRd treatment was continued until disease progression or unacceptable toxicity1
The approval of DARZALEX® for adult patients with newly diagnosed transplant-ineligible multiple myeloma is based on a large, randomized, open-label, multicenter, active-controlled phase 3 trial.1,2
Learn about Mindy, a patient currently on frontline treatment with DRd
Meet MindyTreating to progression in patients with newly diagnosed transplant-ineligible multiple myeloma may prolong progression-free survival and overall survival1,3,4
Continuous treatment in transplant-ineligible patients with newly diagnosed multiple myeloma in the MAIA trial led to:
Improved Outcomes
Progression-Free Survival
44%reduction in the risk of disease progression or death with DRd vs Rd alone after ~30 months of follow-up
(HR=0.56; 95% CI: 0.43-0.73; P<0.0001)1,2*
45%reduction in the risk of disease progression or death with DRd vs Rd alone after 64 months of follow-up
(HR=0.55; 95% CI: 0.45-0.67)1,4†
Overall Survival
32%reduction in the risk of death
with DRd vs Rd alone after
56 months of follow-up
(HR=0.68; 95% CI: 0.53-0.86; P=0.0013)1,4‡
Enhanced Treatment Response
93% ORR was achieved with DRd
vs 81% with Rd at median follow-up of ~30 months1,2
Established Safety Profile
DARZALEX® + Rd offers your patients a frontline treatment supported by
~30 months of safety evaluation and by additional follow-up studies1,2§
AE=adverse event; CI=confidence interval; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; mPFS=median progression-free survival; NE=not estimable; ORR=overall response rate; OS=overall survival; Rd=lenalidomide (R) + dexamethasone (d); TEAE=treatment-emergent adverse event.
*At a median follow-up of ~30 months, mPFS (the primary endpoint) was not reached with DRd vs 31.9 months with Rd alone.1,2
†At a median follow-up of 64 months, mPFS was 61.9 months with DRd (95% CI: 54.8-NE) vs 34.4 months with Rd alone (95% CI: 29.6-39.2).1,4
‡At a median follow-up of 56 months, OS was not reached with DRd or Rd alone.1,5
§TEAEs are defined as any adverse event (AE) that occurs after the start of the first study treatment through 30 days after the last study treatment; or the day prior to start of subsequent antimyeloma therapy, whichever is earlier; or any AE that is considered related (very likely, probably, or possibly related) regardless of the start date of the event; or any AE that is present at baseline but worsens in toxicity grade or is subsequently considered drug-related by the investigator.6
Maintaining treatment benefits
For the best chance of achieving the survival outcomes seen in the MAIA trial, patients should be treated with DARZALEX® + Rd until disease progression or unacceptable toxicity1
Meet Mindy (Age 76): A current frontline DRd patient you may see in your practice*
*Hypothetical patient profileConsidered ineligible for transplant and currently on frontline treatment with DRd
- Likes to spend time in her garden and with her grandchildren
- Good support system: married with one child and 2 young grandchildren
Clinical condition and disease presentation
ISS disease stage: II
ECOG PS: 1
Diagnosed 12 months ago following lower back and
neck pain
Early-stage Parkinson’s disease managed by treatment
Additional considerations
- Mild anemia (9 g/dL)
- Shortness of breath
Transplant eligibility of an individual patient is determined based on evaluation by the treating physician.
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); ECOG PS=Eastern Cooperative Oncology Group performance status; ISS=International Staging System.
References:
DARZALEX® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
Facon T, Kumar S, Plesner T, et al; the MAIA Trial Investigators. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. N Engl J Med. 2019;380(22):2104-2115. doi:10.1056/NEJMoa1817249
Bonello F, Cetani G, Bertamini L, Gay F, Larocca A. Moving toward continuous therapy in multiple myeloma. Clin Hematol Int. 2019;1(4):189-200. doi:10.2991/chi.d.191101.001
Data on file. PM-00912. Janssen Biotech, Inc.
Facon T, Kumar SK, Plesner T, et al. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(11):1582-1596. doi:10.1016/S1470-2045(21)00466-6
Facon T, Kumar SK, Plesner T, et al. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(11):1582-1596 [supplementary appendix].