CEPHEUS
CEPHEUS extended the quadruplet advantage to patients who do not have a transplant.
MRD-negativity (10⁻⁵) 60.9% vs 39.4%; 54-month PFS 68.1% vs 49.5% (HR 0.57). Approved with IMROZ-era labelling in 2025.
Setting
Newly diagnosed transplant-ineligible or -deferred myeloma: Dara-VRd vs VRd
Phase
Phase 3
Sponsor
Janssen
Registry
Headline result
MRD-neg 60.9% vs 39.4%; PFS HR 0.57.
Reported
2024
Enrolled
395
In plain words
What these results mean for people, not percentages
MRD negativity (10⁻⁵)primarysurrogate endpoint
- 60.9 vs 39.4 out of 100 had no detectable disease on sensitive tests with Dara-VRd compared with VRd; 21.5 more per 100.
- Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
Progression-free survival at 54 monthssurrogate endpoint
- 68.1 vs 49.5 out of 100 alive without the cancer growing at 54 months with Dara-VRd compared with VRd; 18.6 more per 100.
- Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 43 percent lower chance of the event at any given time (hazard ratio 0.57, likely range 0.41 to 0.79).
Be careful
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Newly diagnosed transplant-ineligible or -deferred myeloma: Dara-VRd vs VRd. People in a different situation may not see the same effect.
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.
395 participants enrolled.
MRD negativity (10⁻⁵)primary
· p <0.0001
Dara-VRd60.9 of 100
n = 197
VRd39.4 of 100
n = 198
Progression-free survival at 54 months
HR 0.57 (0.41–0.79)
Dara-VRd68.1 of 100
VRd49.5 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| MRD negativity (10⁻⁵)primary | Dara-VRd | 197 | 60.9% | — | <0.0001 | — |
| VRd | 198 | 39.4% | ||||
| Progression-free survival at 54 months | Dara-VRd | — | 68.1% | 0.57 (0.41–0.79) | — | — |
| VRd | — | 49.5% |