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DETERMINATION asked whether people with newly diagnosed myeloma still need a stem-cell transplant when modern three-drug therapy and long maintenance are available; transplant kept the disease away for longer, but after several years the two groups had not lived different lengths of time, so the transplant can be delayed for some.
DETERMINATION (DFCI 10-106) was a US phase 3 trial in transplant-eligible newly diagnosed multiple myeloma. Patients received three cycles of lenalidomide, bortezomib and dexamethasone (RVd) and were then randomised to high-dose melphalan with autologous stem-cell transplant followed by two more RVd cycles, or to five more RVd cycles without transplant. Both arms went on to lenalidomide maintenance until progression, which distinguished it from the parallel French IFM 2009 trial that capped maintenance at one year.
Progression-free survival, the primary endpoint, was significantly longer with early transplant. Overall survival did not differ at the time of the primary report, in part because many patients in the no-transplant arm received a transplant at relapse. The trial supports early transplant as the standard but also a deferred transplant strategy for selected patients.
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.
729 enrolled.
Hazard ratio for progression or death with RVD alone vs transplantation 1.53 (95% CI 1.23 to 1.91), P<0.001; median follow-up 76.0 months
SourceHazard ratio for death with RVD alone vs transplantation 1.10 (95% CI 0.73 to 1.65)
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | RVD + autologous transplantation | 365 | 67.5 months | - | - | link |
| RVD alone | 357 | 46.2 months | ||||
| Overall survival at 5 years | RVD + autologous transplantation | 365 | 80.7% | - | - | link |
| RVD alone | 357 | 79.2% | ||||
| Complete response or better | RVD + autologous transplantation | 365 | 46.8% | - | 0.99 | link |
| RVD alone | 357 | 42% | ||||
| Grade 3 or higher treatment-related adverse events | RVD + autologous transplantation | - | 94.2% | - | - | link |
| RVD alone | - | 78.2% |
Shares Newly diagnosed multiple myeloma, transplant-eligible, Bortezomib, Lenalidomide, Dexamethasone and the tag subtype-trials.
Shares Newly diagnosed multiple myeloma, transplant-eligible, Bortezomib, Lenalidomide, Dexamethasone and the tag subtype-trials.
Shares Newly diagnosed multiple myeloma, transplant-eligible, Bortezomib, Dexamethasone, Multiple myeloma and the tag subtype-trials.
Shares Lenalidomide, Dexamethasone, Multiple myeloma and the tag subtype-trials.
Shares Lenalidomide, PROTACs & molecular glues (targeted protein degradation) and the tag subtype-trials.
Shares Multiple myeloma and the tag subtype-trials.
Shares Lenalidomide, Dexamethasone, PROTACs & molecular glues (targeted protein degradation), Multiple myeloma.
Shares Bortezomib, Dana-Farber Brigham Cancer Center, Lenalidomide, Multiple myeloma.