# CEPHEUS

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

## TL;DR

CEPHEUS extended the quadruplet advantage to patients who do not have a transplant.

## Summary

CEPHEUS, trial NCT03652064 sponsored by Janssen and reported in 2024, extended the quadruplet advantage to newly diagnosed myeloma patients who do not have a transplant, adding daratumumab to bortezomib, lenalidomide and dexamethasone. It randomised 395 transplant-ineligible or transplant-deferred patients and met its primary endpoint of MRD negativity, with a clear progression-free survival benefit at 54 months, and it was approved in 2025 alongside IMROZ-era labelling. OnCo links it to multiple myeloma, daratumumab, bortezomib, lenalidomide, the quadruplet pairing and the CEPHEUS paper. It is notable for using MRD negativity as its main endpoint, and whether regulators accept that surrogate more widely is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03652064
- Phase: 3
- Setting: Newly diagnosed transplant-ineligible or -deferred myeloma: Dara-VRd vs VRd
- Sponsor: Janssen
- Enrolled: 395
- Result: MRD-neg 60.9% vs 39.4%; PFS HR 0.57.
- Outcomes: MRD negativity (10⁻⁵): Dara-VRd 60.9% vs VRd 39.4%; Progression-free survival at 54 months: Dara-VRd 68.1% vs VRd 49.5%, HR 0.57

## Sources

- ClinicalTrials.gov NCT03652064: https://clinicaltrials.gov/study/NCT03652064

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Newly diagnosed multiple myeloma, transplant-ineligible](https://onco.cc/cancers/myeloma-transplant-ineligible/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- drugs: [Bortezomib](https://onco.cc/drugs/bortezomib/), [Daratumumab](https://onco.cc/drugs/daratumumab/), [Lenalidomide](https://onco.cc/drugs/lenalidomide/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- pairings: [CD38 antibody added to PI-IMiD-dex (quadruplet induction)](https://onco.cc/pairings/cd38-plus-triplet/)
- key papers: [CEPHEUS: daratumumab quadruplet for newly diagnosed myeloma patients not having a transplant, with MRD-negativity as the main endpoint](https://onco.cc/key-papers/paper-cepheus-dara-vrd-natmed-2025/)

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