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POLLUX: What the Multiple Myeloma Trial Found
POLLUX added daratumumab to lenalidomide and dexamethasone in myeloma that had already relapsed. The effect at the interim analysis was large enough that the three-drug approach moved quickly into routine use.
Original commentary from the Cancer Explained editorial team.
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An effect size that did not need long to show
POLLUX was published from a protocol-specified interim analysis, after a median of just 13.5 months. Trials are designed with these early looks built in, so that a clear answer does not have to wait for the full timetable.
The answer here was about two-thirds fewer progression events at any moment in time. That is an unusually large effect for a drug added to a regimen that already works.
Who was eligible
| Field | Detail |
|---|---|
| Trial | POLLUX |
| Identifier | NCT02076009 |
| Phase | Phase 3 |
| Design | Randomised, open-label |
| Cancer type | Multiple myeloma after at least one previous line of treatment |
| Comparator | Daratumumab with lenalidomide and dexamethasone, against lenalidomide and dexamethasone alone |
| Primary endpoint | Progression-free survival |
569 people took part: 286 got daratumumab added, 283 got the two-drug regimen. Everyone had already been treated at least once and the myeloma had come back or stopped responding.
What the interim analysis showed
169 people had progressed or died by the analysis: 53 of 286 in the daratumumab group (18.5%) and 116 of 283 in the control group (41.0%).
The hazard ratio was 0.37 (95% CI 0.27 to 0.52, p<0.001). At 12 months, 83.2% of the daratumumab group (95% CI 78.3 to 87.2) were alive without progression, against 60.1% (95% CI 54.0 to 65.7).
Median progression-free survival was not reached in the daratumumab group. The curve had not fallen far enough to find a midpoint.
Deeper remissions, not just longer ones
Responses were both more common and better.
- Any response: 92.9% against 76.4% (p<0.001)
- Complete response or better: 43.1% against 19.2% (p<0.001)
- No myeloma detectable at one cell in 100,000: 22.4% against 4.6% (p<0.001)
That last line is minimal residual disease testing. Falling below that threshold was linked to better outcomes in this trial, which is part of why the depth of response, not only its length, drew attention.
Infusion reactions and blood counts
Daratumumab is given by drip, and reactions during infusion happened in 47.7% of those receiving it — mostly mild, grade 1 or 2, and usually during the first dose.
Severe blood-count effects split unevenly. Low neutrophils were more common with daratumumab (51.9% against 37.0%). Anaemia was less common (12.4% against 19.6%). Low platelets were about the same (12.7% against 13.5%).
What this trial cannot tell you
- Whether people live longer. Progression-free survival was the endpoint. Overall survival was not established here.
- How durable the benefit is. This is an interim look at a median of 13.5 months, with the daratumumab median not reached.
- How it compares with other three-drug combinations. The control was the two-drug regimen, not a rival triplet.
- Anything about first-line use. Everyone here had already relapsed.
Questions when myeloma comes back
- Which drugs have I already had, and what does that rule out now?
- What happens during a daratumumab infusion, and how long does the first one take?
- How will you know whether this is working, and how soon?
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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