# CASSIOPEIA

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

## TL;DR

CASSIOPEIA showed that adding the CD38 antibody daratumumab to a three-drug induction before stem cell transplant put more people with myeloma into deep remission and kept the disease away for longer.

## Summary

CASSIOPEIA, run by the French and Dutch myeloma groups with Janssen, randomised 1085 transplant-eligible patients with newly diagnosed multiple myeloma to VTd (bortezomib, thalidomide, dexamethasone) induction and post-transplant consolidation with or without daratumumab (part 1), then re-randomised responders to daratumumab maintenance or observation (part 2). The part 1 primary endpoint was the stringent complete response rate after consolidation.

Daratumumab-VTd increased stringent complete responses and minimal residual disease negativity and lengthened progression-free survival, leading to European and United States approval of the quadruplet in 2019 and 2020, the first daratumumab approval in the transplant setting. Part 2 showed that daratumumab maintenance lengthened progression-free survival mainly in patients who had not received it during induction.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT02541383
- Phase: 3
- Setting: Transplant-eligible newly diagnosed multiple myeloma: bortezomib, thalidomide and dexamethasone (VTd) induction and consolidation with or without daratumumab, then daratumumab maintenance or observation
- Sponsor: Intergroupe Francophone du Myelome
- Enrolled: 1085
- Result: Daratumumab added to VTd increased stringent complete responses and lengthened progression-free survival; approved for transplant-eligible myeloma in 2019 (EU) and 2020 (US).

## Sources

- ClinicalTrials.gov NCT02541383: https://clinicaltrials.gov/study/NCT02541383

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Newly diagnosed multiple myeloma, transplant-eligible](https://onco.cc/cancers/myeloma-transplant-eligible/)
- drugs: [Bortezomib](https://onco.cc/drugs/bortezomib/), [Daratumumab](https://onco.cc/drugs/daratumumab/), [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Thalidomide](https://onco.cc/drugs/thalidomide/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- people: [Philippe Moreau](https://onco.cc/people/philippe-moreau/)
- key papers: [CASSIOPEIA: daratumumab added to bortezomib, thalidomide and dexamethasone before and after transplant in newly diagnosed myeloma](https://onco.cc/key-papers/paper-cassiopeia-lancet-2019/)

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