# MAIA

Source: https://onco.cc/trials/maia/  
OnCo record `maia` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

MAIA showed that adding the antibody daratumumab to the standard two-drug regimen kept newly diagnosed myeloma under control for far longer in older people who cannot have a transplant, and later that they lived longer too, which made the three-drug regimen a standard first treatment.

## Summary

MAIA was an open-label phase 3 trial in newly diagnosed multiple myeloma in patients ineligible for high-dose therapy and autologous transplant because of age or comorbidity. Patients were randomised to daratumumab plus lenalidomide and dexamethasone or to lenalidomide and dexamethasone, in both arms until progression.

The daratumumab arm had significantly longer progression-free survival, the primary endpoint, with deeper responses and more patients reaching measurable residual disease negativity. The regimen was approved in the United States in June 2019 for this setting, and a later analysis showed an overall survival benefit as well. MAIA and ALCYONE established daratumumab in first-line myeloma; CEPHEUS and IMROZ have since added it or isatuximab to bortezomib-containing triplets.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT02252172
- Phase: 3
- Setting: Newly diagnosed multiple myeloma in patients not eligible for autologous transplant: daratumumab with lenalidomide and dexamethasone against lenalidomide and dexamethasone, both continued until progression
- Sponsor: Janssen
- Enrolled: 737
- Result: Daratumumab, lenalidomide and dexamethasone improved progression-free and later overall survival over lenalidomide and dexamethasone in transplant-ineligible newly diagnosed myeloma; approved in June 2019.

## Sources

- ClinicalTrials.gov NCT02252172: https://clinicaltrials.gov/study/NCT02252172

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Newly diagnosed multiple myeloma, transplant-ineligible](https://onco.cc/cancers/myeloma-transplant-ineligible/)
- drugs: [Daratumumab](https://onco.cc/drugs/daratumumab/), [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Lenalidomide](https://onco.cc/drugs/lenalidomide/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- people: [Thierry Facon](https://onco.cc/people/thierry-facon/)
- key papers: [MAIA: adding daratumumab to lenalidomide-dexamethasone for older patients with newly diagnosed myeloma who cannot have a transplant](https://onco.cc/key-papers/paper-maia-daratumumab-rd-nejm-2019/)

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