# MAIA: adding daratumumab to lenalidomide-dexamethasone for older patients with newly diagnosed myeloma who cannot have a transplant

Source: https://onco.cc/key-papers/paper-maia-daratumumab-rd-nejm-2019/  
OnCo record `paper-maia-daratumumab-rd-nejm-2019` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the CD38 antibody daratumumab to standard lenalidomide-dexamethasone cut the risk of progression or death by about 44% in older myeloma patients, and later extended survival.

## Summary

MAIA randomised 737 transplant-ineligible patients with newly diagnosed multiple myeloma (median age 73) to daratumumab plus lenalidomide and dexamethasone (D-Rd) or Rd alone, both continued until progression. The primary endpoint was PFS. At 30 months PFS was 70.6% versus 55.6% (hazard ratio 0.56); complete response or better was 47.6% versus 24.9% and MRD-negativity 24.2% versus 7.3%. Longer follow-up showed a significant overall survival benefit (hazard ratio about 0.68; five-year OS roughly 66% versus 53%). Neutropenia and pneumonia were more frequent with daratumumab.

## Fields

- Kind: Key paper
- Last checked: 2026-09-08
- Journal: New England Journal of Medicine
- Year: 2019
- DOI: 10.1056/NEJMoa1817249
- Authors: Facon T, Kumar S, Plesner T, et al.
- Findings: 737 transplant-ineligible patients; D-Rd vs Rd until progression.; 30-month PFS 70.6% vs 55.6%; hazard ratio 0.56.; Complete response or better 47.6% vs 24.9%; MRD-negativity (10^-5) 24.2% vs 7.3%.; Overall survival significantly improved at longer follow-up (HR about 0.68; 5-year OS roughly 66% vs 53%).; Grade 3-4 neutropenia 50.0% vs 35.3%; pneumonia 13.7% vs 7.9%.
- What it means: MAIA made a daratumumab-based triplet the standard first treatment for older or frail myeloma patients, replacing Rd alone. It proved an anti-CD38 antibody could improve survival, not just delay progression, when used up front. Quadruplets built on this backbone are now being tested in the same population.
- Caveats: Continuous therapy until progression; treatment burden and cost are substantial.; Patients over 80 and very frail patients were under-represented.; Median PFS was not reached at the primary analysis; the durability estimate relies on later reports.; Comparator Rd is itself now being displaced by quadruplets.

## Sources

- Full text (DOI): https://doi.org/10.1056/NEJMoa1817249
- ClinicalTrials.gov NCT02252172: https://clinicaltrials.gov/study/NCT02252172

## Connected records

- key papers: [CEPHEUS: daratumumab quadruplet for newly diagnosed myeloma patients not having a transplant, with MRD-negativity as the main endpoint](https://onco.cc/key-papers/paper-cepheus-dara-vrd-natmed-2025/)
- pairings: [CD38 antibody added to PI-IMiD-dex (quadruplet induction)](https://onco.cc/pairings/cd38-plus-triplet/)
- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Newly diagnosed multiple myeloma, transplant-ineligible](https://onco.cc/cancers/myeloma-transplant-ineligible/)
- targets: [CD38](https://onco.cc/targets/cd38/)
- drugs: [Daratumumab](https://onco.cc/drugs/daratumumab/), [Lenalidomide](https://onco.cc/drugs/lenalidomide/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- terms: [MRD negativity (myeloma, 10⁻⁵ / 10⁻⁶)](https://onco.cc/terms/mrd-negativity-myeloma/), [Overall survival (OS)](https://onco.cc/terms/os/), [Progression-free survival (PFS)](https://onco.cc/terms/pfs/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)
- people: [Thierry Facon](https://onco.cc/people/thierry-facon/)
- trials: [MAIA](https://onco.cc/trials/maia/)

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