Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials

Abstract

Objective: A post hoc analysis of two phase III trials was carried out to explore the influence of age and treatment factors on the effect of bortezomib consolidation on progression-free survival (PFS) post autologous stem cell transplantation (ASCT). Methods:Patients with newly diagnosed multiple myeloma were assigned to one of two trials (ClinicalTrials.gov IDs: NCT00416273, NCT00416208), which were conducted in parallel, based on age (18-60 or 61-75 years, respectively). Following induction and ASCT, patients were randomized 1:1 to four 35-day cycles of bortezomib consolidation (1.6 mg/m 2 IV on days 1, 8,15,22) or observation only.

Full or intensity‐reduced high‐dose melphalan and single or double autologous stem cell transplant with or without bortezomib consolidation in patients with newly diagnosed multiple myeloma

“…13 Interestingly, bortezomib consolidation equalized outcomes of younger (18-60 years) and older patients (61-75 years). 17 Higher age was only partially equi- The division of standard MEL200 in two equal portions of MEL100 to reduce toxicity in older patients was shown to be superior to conventional chemotherapy with melphalan and prednisone by the Italian study group GIMEMA. 31 In a retrospective singlecenter study with 437 patients, PFS and OS were similar in older patients treated with 2 × MEL100 and younger patients receiving 1 × MEL200.…”

“…A total of 380 patients were enrolled into the two trials. 17 Nine patients withdrew consent and were therefore excluded. In 17 patients, information on melphalan is missing and in 14 patients melphalan dose did not fit into the categories applied.…”

“…When the two trials were analyzed separately, median PFS was comparable in both age groups with bortezomib consolidation but shorter for older patients who did not receive bortezomib. 17 The older patients (61-75 years) had received the standard highdose MEL200 about three times less often than younger patients (18-60 years). However, the proportion of patients receiving single/ double ASCT was similar between the two age groups.…”

Venetoclax in combination with carfilzomib, doxorubicin and dexamethasone restores responsiveness in an otherwise treatment-refractory multiple myeloma patient

“…Thereafter, substantial reduction of PC BM infiltration (<10%) was obtained and all MM specific markers (IgG, κ-SFLC) returned to normal (very good partial response [VGPR] according to International Myeloma Working Group [IMWG] criteria). Maintenance was at that time not approved and a clinical trial offering maintenance 6,7 was refused by the patient.…”

“…Thereafter, maintenance therapy was applied with VD. 6,7 Three years after the second ASCT, the patient presented with increased serological markers (κ-SFLCs 25 mg/L), BM infiltration of 80%, and t(11;14) and gain 1q21 confirmed by FISH. Eight-color multiparameter flow cytometry (MFC; Figure 1B) revealed aberrant PC (aPC) (16% of cells).…”