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MAIA

Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma (MAIA)

Phase 3N = 737NCT02252172

Population
Newly diagnosed multiple myeloma, ineligible for autologous stem-cell transplantation.
Design
Phase 3 trial: 737 patients with newly diagnosed myeloma ineligible for autologous stem-cell transplantation were randomly assigned to daratumumab plus lenalidomide and dexamethasone or lenalidomide and dexamethasone alone, continued until progression or unacceptable side effects. The primary end point was progression-free survival. The primary report (NEJM 2019) and the long-term outcomes paper (Leukemia 2025, median follow-up 64.5 months) are separate analyses.
Primary endpoint
PFS
Arms
  • Daratumumab + Rd (experimental, n = 368): Daratumumab with lenalidomide and dexamethasone
  • Rd (control, n = 369): Lenalidomide and dexamethasone
People
Facon T
PFSHR 0.56 (95% CI 0.43–0.73)Δ 30-month PFS+15 pointsΔ ≥CR rate+22.7 pointsΔ MRD+16.9 pointsPFSHR 0.55 (95% CI 0.45–0.67)Δ median PFS+27.5 months
Show the numbers
Results reported for MAIA
EndpointAnalysisDaratumumab + RdRdEffect
PFSRandomised patients (737)primarymedian follow-up 28 monthsFacon 201970.6% at 30 mo (65.0–75.4%)55.6% at 30 mo (49.5–61.3%)HR 0.56 (95% CI 0.43–0.73)P<0.001Disease progression or death occurred in 97 of 368 patients (26.4%) with daratumumab and 143 of 369 (38.8%) with control. Grade 3 or 4 neutropenia 50.0% versus 35.3%; pneumonia 13.7% versus 7.9%.
≥CR rateRandomised patients (737)primaryFacon 201947.6%24.9%P<0.001
MRDRandomised patients (737)primaryFacon 201924.2%7.3%P<0.001
PFSRandomised patients (737)long term-updatemedian follow-up 64.5 monthsFacon 2025median 61.9 monthsmedian 34.4 monthsHR 0.55 (95% CI 0.45–0.67)P<0.0001
OSRandomised patients (737)long term-updatemedian follow-up 64.5 monthsFacon 202566.6% at 5 ymedian 65.5 months; 53.6% at 5 yHR 0.66 (95% CI 0.53–0.83)P=0.0003Median overall survival was not reached in the daratumumab group.
≥CR rateRandomised patients (737)long term-updatemedian follow-up 64.5 monthsFacon 202551.1%30.1%P<0.0001
MRDRandomised patients (737)long term-updatemedian follow-up 64.5 monthsFacon 202532.1%11.1%P<0.0001Sustained MRD negativity (at least 18 months) was 16.8% versus 3.3%.
Results reported for MAIA
EndpointAnalysisDaratumumab + RdRdEffect
PFSRandomised patients (737)primarymedian follow-up 28 monthsFacon 201970.6% at 30 mo (65.0–75.4%)55.6% at 30 mo (49.5–61.3%)HR 0.56 (95% CI 0.43–0.73)P<0.001Disease progression or death occurred in 97 of 368 patients (26.4%) with daratumumab and 143 of 369 (38.8%) with control. Grade 3 or 4 neutropenia 50.0% versus 35.3%; pneumonia 13.7% versus 7.9%.
≥CR rateRandomised patients (737)primaryFacon 201947.6%24.9%P<0.001
MRDRandomised patients (737)primaryFacon 201924.2%7.3%P<0.001
PFSRandomised patients (737)long term-updatemedian follow-up 64.5 monthsFacon 2025median 61.9 monthsmedian 34.4 monthsHR 0.55 (95% CI 0.45–0.67)P<0.0001
OSRandomised patients (737)long term-updatemedian follow-up 64.5 monthsFacon 202566.6% at 5 ymedian 65.5 months; 53.6% at 5 yHR 0.66 (95% CI 0.53–0.83)P=0.0003Median overall survival was not reached in the daratumumab group.
≥CR rateRandomised patients (737)long term-updatemedian follow-up 64.5 monthsFacon 202551.1%30.1%P<0.0001
MRDRandomised patients (737)long term-updatemedian follow-up 64.5 monthsFacon 202532.1%11.1%P<0.0001Sustained MRD negativity (at least 18 months) was 16.8% versus 3.3%.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.560.43–0.73
PFS0.550.45–0.67
OS0.660.53–0.83
Illustrative — modelled from reported values, not trial data. PFS, long term-update.
0%25%50%75%100%020406080100120140Months (modelled)
  • Daratumumab + Rd (experimental)
  • Rd (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsDaratumumab + RdRd
0100.0%100.0%
3964.6%45.6%
7742.2%21.2%
11627.3%9.7%
15517.6%4.4%
Illustrative — modelled from reported values, not trial data. OS, long term-update.
0%25%50%75%100%050100150Months (modelled)
  • Rd (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsRd
0100.0%
4164.8%
8242.0%
12327.2%
16417.6%
Primary publication: Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019;380(22):2104-2115. PubMedDOI

Appears in

Sources

  1. Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019;380(22):2104-2115.

    PubMedDOI

  2. Facon T, Moreau P, Weisel K, Goldschmidt H, Usmani SZ, Chari A, et al. Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes. Leukemia. 2025;39(4):942-950.

    PubMedDOI