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IFM 2009 asked whether a stem cell transplant is still needed when myeloma is treated with modern three-drug therapy; the transplant kept the disease away for longer, though patients lived about as long either way because those who relapsed could be transplanted later.
The French IFM 2009 trial randomised 700 adults up to 65 with newly diagnosed multiple myeloma to eight cycles of lenalidomide, bortezomib and dexamethasone (RVD), or to three cycles of RVD, high-dose melphalan with autologous stem cell transplant and two further RVD cycles. Both arms received one year of lenalidomide maintenance. The primary endpoint was progression-free survival.
Early transplant lengthened progression-free survival and produced deeper responses, including more patients with no detectable minimal residual disease, but overall survival was similar because most patients in the RVD-alone arm received a transplant at relapse. The trial, and the parallel DETERMINATION trial in the United States, defined transplant as a component that lengthens remission rather than life in the era of triplet induction, and framed the current question of whether quadruplets and CAR-T can replace it.
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.
700 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | RVD + high-dose melphalan and transplantation | 350 | 50 months | 0.65 | <0.001 | link |
| RVD alone | 350 | 36 months | ||||
| Complete response | RVD + high-dose melphalan and transplantation | - | 59% | - | 0.03 | link |
| RVD alone | - | 48% | ||||
| Minimal residual disease not detected | RVD + high-dose melphalan and transplantation | - | 79% | - | <0.001 | link |
| RVD alone | - | 65% | ||||
| Overall survival at 4 years | RVD + high-dose melphalan and transplantation | - | 81% | - | - | link |
| RVD alone | - | 82% |
Shares Newly diagnosed multiple myeloma, transplant-eligible, Bortezomib, Lenalidomide, 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 Newly diagnosed multiple myeloma, transplant-eligible, Bortezomib, Lenalidomide, Dexamethasone 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, Lenalidomide, Dexamethasone, Multiple myeloma.