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MAIA: What the Multiple Myeloma Trial Found
MAIA studied the myeloma patients most trials leave out — people too frail or too old for a stem-cell transplant. Adding daratumumab produced remissions deep enough to be undetectable, without a transplant.
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A trial for the patients myeloma trials usually skip
Much of what is known about treating myeloma comes from studies of people fit enough for an autologous stem-cell transplant: high-dose chemotherapy followed by a rescue with the person's own stored blood stem cells. That is a demanding process, and many people newly diagnosed with myeloma are not candidates for it.
MAIA enrolled exactly those people. Everyone in it had newly diagnosed myeloma and was judged ineligible for a transplant.
What the two regimens were
| Field | Detail |
|---|---|
| Trial | MAIA |
| Identifier | NCT02252172 |
| Phase | Phase 3 |
| Design | Randomised, open-label |
| Cancer type | Newly diagnosed multiple myeloma, not eligible for stem-cell transplant |
| Comparator | Daratumumab with lenalidomide and dexamethasone, against lenalidomide and dexamethasone alone |
| Primary endpoint | Progression-free survival |
737 people were randomised: 368 to the three-drug regimen and 369 to the two-drug one. Treatment was not for a fixed number of cycles. It continued until the myeloma got worse or the side effects became unacceptable.
The progression-free survival result
At a median follow-up of 28.0 months, the myeloma had progressed or the person had died in 97 of 368 on daratumumab (26.4%) and 143 of 369 in the control group (38.8%).
At 30 months, 70.6% of the daratumumab group (95% CI 65.0 to 75.4) were alive without progression, against 55.6% (95% CI 49.5 to 61.3). The hazard ratio was 0.56 (95% CI 0.43 to 0.73, p<0.001).
Median progression-free survival was 31.9 months in the control group and had not been reached on daratumumab. Fewer than half of that group had had an event, so the full size of the gain was still unknown when this was published.
Depth of response, and what MRD means
Complete response or better was reached by 47.6% on daratumumab and 24.9% on the control regimen (p<0.001).
Beyond that lies minimal residual disease testing, which looks for myeloma cells at a level a standard test cannot see. The threshold here was one tumour cell in 100,000 white cells. 24.2% of the daratumumab group fell below it, against 7.3% (p<0.001).
That number is the reason MAIA landed hard. Remissions that deep had been associated with transplant. Here they were reached without one.
The price: infections, and treatment that does not stop
Severe side effects were more common on daratumumab in some columns and less in others.
- Low neutrophils: 50.0% against 35.3%
- Pneumonia: 13.7% against 7.9%
- Low lymphocytes: 15.1% against 10.7%
- Anaemia: 11.8% against 19.7% — lower with daratumumab
The infection signal is the one to watch, because these regimens run indefinitely. Continuous treatment means continuous clinic visits, continuous cost, and a continuously suppressed immune system.
What this does not mean
- It does not mean transplant is unnecessary. Nobody in this trial was a transplant candidate, so the two approaches were never compared.
- It does not establish longer life. Progression-free survival was the primary endpoint, and median overall survival had not been reached in either group.
- It was open-label. There was no placebo infusion in the control group.
- Undetectable disease is not the same as cure. MRD testing has a floor; below it, the test simply stops seeing.
Questions at a new myeloma diagnosis
- Am I a transplant candidate, and what makes you say so?
- If treatment continues indefinitely, what does that look like month to month?
- What should I do about a fever or a cough while I am on this?
Sources
This article was written from the sources below, which were checked on the source-check date shown above.
How this article was prepared
Prepared by Cancer Explained's AI-assisted editorial system and checked against the sources listed below. This article has not been reviewed by a healthcare professional unless a named reviewer is specifically shown.
Cancer Explained is published by the National Cancer Information Foundation as a nonprofit-oriented public-interest education project. It is not a diagnostic service, does not recommend treatments, and is not for emergencies.
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