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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
737 enrolled.
Median follow-up 28.0 months
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival at 30 monthsprimary | Daratumumab + lenalidomide + dexamethasone | 368 | 70.6% | 0.56 (0.43 to 0.73) | <0.001 | link |
| Lenalidomide + dexamethasone | 369 | 55.6% | ||||
| Complete response or better | Daratumumab + lenalidomide + dexamethasone | 368 | 47.6% | - | <0.001 | link |
| Lenalidomide + dexamethasone | 369 | 24.9% | ||||
| Minimal residual disease negativity (10^-5) | Daratumumab + lenalidomide + dexamethasone | 368 | 24.2% | - | <0.001 | link |
| Lenalidomide + dexamethasone | 369 | 7.3% |
Shares Daratumumab, Lenalidomide, Dexamethasone, Johnson & Johnson and the tag subtype-trials.
Shares Daratumumab, Dexamethasone, Johnson & Johnson, Monoclonal antibodies and the tag subtype-trials.
Shares Daratumumab, Johnson & Johnson, Monoclonal antibodies, Multiple myeloma and the tag subtype-trials.
Shares Lenalidomide, Dexamethasone, Multiple myeloma and the tag subtype-trials.
Shares Lenalidomide, Dexamethasone, Multiple myeloma and the tag subtype-trials.
Shares Johnson & Johnson and the tag subtype-trials.
Shares Johnson & Johnson and the tag subtype-trials.
Shares Monoclonal antibodies and the tag subtype-trials.