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Survival of transplant-eligible newly diagnosed MM in FORTE trial

Presented by
Dr Francesca Gay, GIMEMA, European Myeloma Network, Italy
ASH 2020
Phase 2, FORTE
Lenalidomide alone is a standard maintenance treatment after an autologous stem cell transplantation (autoSCT). The phase 2 FORTE trial demonstrated that the addition of carfilzomib to lenalidomide maintenance improved progression-free survival (PFS) in patients with transplant-eligible newly diagnosed multiple myeloma (MM).

The FORTE trial (NCT02203643) investigated safety and efficacy of the proteasome inhibitor carfilzomib in combination with either lenalidomide-dexamethasone (KRd) or cyclophosphamide-dexamethasone (KCd) in induction and consolidation of MM [1]. Secondary aim of the study was to evaluate maintenance treatment between carfilzomib plus lenalidomide or versus lenalidomide alone. The trial enrolled 474 MM patients who were transplant-eligible and aged <65 years. They were randomised in the following induction and consolidation treatments:

  • KRd induction, followed by autoSCT and KRd consolidation (KRd_ASCT);
  • 12 cycles of KRd (KRd12); and
  • KCd induction, followed by autoSCT and KCd consolidation (KCd_ASCT).

Afterwards, patients were randomised again to maintenance with lenalidomide alone (R) until progression or carfilzomib plus lenalidomide (KR). Intention-to-treat (ITT) data of pre-maintenance measurable residual disease (MRD) and safety of the induction/consolidation phases in the 3 arms were reported previously [2,3]. Dr Francesca Gay (GIMEMA, European Myeloma Network, Italy) presented the most recent data.

After a median follow-up from first randomisation of 45 months, median PFS was not reached with KRd_ASCT, PFS was 57 months with KRd12, and 53 months with KCd_ASCT:

  • KRd_ASCT vs KCd_ASCT: HR 0.53, P<0.001;
  • KRd_ASCT vs KRd12: HR 0.64, P=0.023; and
  • KRd12 vs KCd_ASCT: HR 0.82, P=0.262.

After a median follow-up from second randomisation of 31 months and a median duration of maintenance of 27 months in both arms, 46% of MRD-positive patients at randomisation turned negative in KR versus 32% in R (P=0.04). By ITT analysis, 3-year PFS from second randomisation was 75% with KR versus 66% with R (HR 0.63; P=0.026). Maintenance with KR was manageable with no increase in treatment discontinuation due to toxicity.

  1. Gay F, et al. Survival Analysis of Newly Diagnosed Transplant-Eligible Multiple Myeloma Patients in the Randomized Forte Trial. 62nd ASH Annual Meeting, 5-8 December 2020. Abstract 141.
  2. Gay F, et al. Blood. 2018;132(Suppl_1):121.
  3. Oliva S, et al. Blood. 2019;134(Suppl_1):4322.

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