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Phase II FORTE Trial Compares Combination Therapies Plus ASCT in Multiple Myeloma

By: Lauren Harrison, MS
Posted: Tuesday, March 22, 2022

The combination of carfilzomib, lenalidomide, and dexamethasone (KRd) with autologous stem cell transplantation (ASCT) was superior to other carfilzomib-based induction and consolidation approaches with or without transplantation in patients with multiple myeloma. Mario Boccadoro, MD, of the University of Torino, Turin, Italy, and his colleagues published the results of the FORTE trial in The Lancet Oncology.

This open-label, phase II trial enrolled 474 patients with newly diagnosed multiple myeloma who were eligible for a stem cell transplant. Patients were randomly assigned 1:1:1 to one of three treatments: (1) KRd plus ASCT; (2) 12 28-day cycles of KRd; or (3) carfilzomib, cyclophosphamide, and dexamethasone (KCd) plus ASCT. Afterward, patients were stratified according to induction-consolidation treatment and randomly assigned again 1:1 to receive maintenance treatment with carfilzomib plus lenalidomide or lenalidomide alone.

After a median follow-up of 50.9 months from the first randomization, 70% of patients receiving either of the lenalidomide combinations and 53% of those receiving the cyclophosphamide combination had at least a very good partial response after induction (odds ratio = 2.14, P = .002). The median follow-up after the second randomization was 37.3 months, and the 3-year progression-free survival rates were 75% and 65% for the carfilzomib/lenalidomide maintenance and the lenalidomide-alone groups, respectively (hazard ratio = 0.64, P = .023).

During the induction and consolidation portion of the trial, the most common grade 3 or 4 adverse events included neutropenia (13% with KRd plus ASCT, 10% with KRTd alone, and 11% KCd plus ASCT), dermatologic toxicity (6%, 8%, and 1%, respectively), and hepatic toxicity (8%, 8%, and 0%). The most common serious adverse event was pneumonia in 4%, 3%, and 3% with KRd plus ASCT, KRd alone, and KCd.

Disclosure: For a full list of authors’ disclosures, visit

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