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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.
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.
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.
1,085 enrolled.
Not reached · Not reached
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Stringent complete response at day 100 after transplantation (part 1)primary | Daratumumab + VTd | 543 | 29% | - | 0.0010 | link |
| VTd | 542 | 20% | ||||
| Minimal residual disease negativity (10^-5, flow cytometry) | Daratumumab + VTd | 543 | 64% | - | <0.0001 | link |
| VTd | 542 | 44% | ||||
| Progression-free survival from first randomisation | Daratumumab + VTd | - | Not reached | 0.47 (0.33 to 0.67) | <0.0001 | link |
| VTd | - | Not reached |
Shares Newly diagnosed multiple myeloma, transplant-eligible, Daratumumab, Bortezomib, Dexamethasone and the tag subtype-trials.
Shares Intergroupe Francophone du Myélome (IFM), Newly diagnosed multiple myeloma, transplant-eligible, Bortezomib, Dexamethasone and the tag subtype-trials.
Shares Daratumumab, Dexamethasone, Johnson & Johnson, Monoclonal antibodies and the tag subtype-trials.
Shares Newly diagnosed multiple myeloma, transplant-eligible, Bortezomib, Dexamethasone, Multiple myeloma and the tag subtype-trials.
Shares Daratumumab, Johnson & Johnson, Monoclonal antibodies, Multiple myeloma and the tag subtype-trials.
Shares Johnson & Johnson and the tag subtype-trials.
Shares Johnson & Johnson and the tag subtype-trials.
Shares Monoclonal antibodies and the tag subtype-trials.