Results from two phase III studies of bortezomib (BTZ) consolidation vs observation (OBS) post-transplant in patients (pts) with newly diagnosed multiple myeloma (NDMM).

Straka, Christian; Vogel, Martin; Müller, Jürgen; Kropff, Martin; Metzner, Bernd; Langer, Christian; Sayer, Herbert G.; Jung, Wolfram; Dürk, Heinz; Wandt, Hannes; Bassermann, Florian; Gramatzki, Martin; Rösler, Wolf; Knop, Stefan; Wolf, Hans‐Heinrich; Brugger, Wolfram; Engelhardt, Monika; Fischer, Thomas; Einsele, Hermann

doi:10.1200/jco.2015.33.15_suppl.8511

Cited by 12 publications

(10 citation statements)

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“…Experimental log‐rank P ‐values for the between‐arm comparisons of PFS and OS were not statistically significant, most likely due to the small sample size and the study not being powered to compare survival outcomes. The trends for improved response rates and/or survival outcomes with bortezomib consolidation in this study are consistent with previous clinical studies in the ASCT‐eligible MM setting (Ladetto et al , ; Cavo et al , ; Leleu et al , ; Mellqvist et al , ; Straka et al , ).…”

Section: Discussionsupporting

confidence: 90%

“…Rates of grade ≥3 TEAEs were low in both arms (10% bortezomib versus 6% observation). TEAEs occurring with notably higher frequency in the bortezomib arm (diarrhoea, peripheral sensory neuropathy, nausea, vomiting) are consistent with known bortezomib‐associated toxicities, indicating that the between‐arm differences in safety findings correspond well with the known safety profile for bortezomib in MM (Cavo et al , ; Mellqvist et al , ; Straka et al , ; http://www.velcade.com/files/pdfs/velcade_prescribing_information.pdf). It is of note that patients in the bortezomib arm received intravenous bortezomib.…”

Section: Discussionsupporting

confidence: 55%

“…In addition, patients in the bortezomib arm received only four 35-day cycles of bortezomib consolidation at 1Á6 mg/m 2 . Although this regimen is in line with other bortezomib consolidation studies (Ladetto et al, 2010;Straka et al, 2015), it remains possible that a longer duration of consolidation therapy may be required to demonstrate an effect over observation alone (Greenfield et al, 2014). The Nordic Myeloma Study Group administered 6 cycles of bortezomib consolidation in their phase 3 trial, albeit at a lower dose of 1Á3 mg/m 2 (Mellqvist et al, 2013).…”

Section: Discussionmentioning

confidence: 96%

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Effects of single‐agent bortezomib as post‐transplant consolidation therapy on multiple myeloma‐related bone disease: a randomized phase II study

et al. 2017

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Summary This phase II study explored the effects of bortezomib consolidation versus observation on myeloma‐related bone disease in patients who had a partial response or better after frontline high‐dose therapy and autologous stem cell transplantation. Patients were randomized to receive four 35‐day cycles of bortezomib 1·6 mg/m2 intravenously on days 1, 8, 15 and 22, or an equivalent observation period, and followed up for disease status/survival. The modified intent‐to‐treat population included 104 patients (51 bortezomib, 53 observation). There were no meaningful differences in the primary endpoint of change from baseline to end of treatment in bone mineral density (BMD). End‐of‐treatment rates (bortezomib versus observation) of complete response/stringent complete response were 22% vs. 11% (P = 0·19), very good partial response or better of 80% vs. 68% (P = 0·17), and progressive disease of 8% vs. 23% (P = 0·06); median progression‐free survival was 44·9 months vs. 21·8 months (P = 0·22). Adverse events observed ≥15% more frequently with bortezomib versus observation were diarrhoea (37% vs. 0), peripheral sensory neuropathy (20% vs. 4%), nausea (18% vs. 0) and vomiting (16% vs. 0). Compared with observation, bortezomib appeared to have little impact on bone metabolism/health, but was associated with trends for improved myeloma response and survival.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 55%

Section: Discussionmentioning

confidence: 96%

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Effects of single‐agent bortezomib as post‐transplant consolidation therapy on multiple myeloma‐related bone disease: a randomized phase II study

et al. 2017

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“…Bortezomib consolidation was found superior to no consolidation in three large phase III trials. Following consolidation, VGPR rate reached 71% in the study by the Nordic Myeloma Study Group, and the rate of VGPR or better was 62% in the joint report of the MMY3012 and MMY3013 trials . A more recent phase II study reported a VGPR or better rate of 80% .…”

Section: Discussionmentioning

confidence: 99%

Consolidation therapy with the combination of bortezomib and lenalidomide (VR) without dexamethasone in multiple myeloma patients after transplant: Effects on survival and bone outcomes in the absence of bisphosphonates

Terpos

Kastritis

Ntanasis‐Stathopoulos

et al. 2019

American J Hematol

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Optimizing consolidation treatment in transplant‐eligible newly diagnosed multiple myeloma patients in order to improve efficacy and bone‐related outcomes is intriguing. We conducted an open‐label, prospective study evaluating the efficacy and safety of bortezomib and lenalidomide (VR) consolidation after ASCT, in the absence of dexamethasone and bisphosphonates. Fifty‐nine patients, who received bortezomib‐based induction, were given 4 cycles of VR starting on day 100 post‐ASCT. After ASCT, 58% of patients improved their response status, while following VR consolidation 39% further deepened their response; stringent complete response rates increased to 51% after VR from 24% post‐ASCT. VR consolidation resulted in a significant reduction of soluble receptor activator of nuclear factor‐κB ligand/osteoprotegerin ratio and sclerostin circulating levels, which was more pronounced among patients achieving very good partial response or better. After a median follow‐up of 62 months, no skeletal‐related events (SREs) were observed, despite the lack of bisphosphonates administration. The median TTP after ASCT was 37 months, while median overall survival (OS) has not been reached yet; the probability of 4‐ and 5‐year OS was 81% and 64%, respectively. In conclusion, VR consolidation is an effective, dexamethasone‐ and bisphosphonate‐free approach, which offers long OS with improvements on bone metabolism and no SREs.

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“…Several studies have shown that consolidation therapy after ASCT improved the level of response and PFS, however, no OS benefit has been shown. 79–81 The evaluation of consolidation followed by maintenance therapy versus maintenance therapy alone in newly diagnosed, transplant-eligible MM patients in the randomized phase III EMN02/HO95 trial showed improved PFS with VRD consolidation across most predefined subgroups, but not in patients with high-risk cytogenetics. 82 As previously described, the recently published result of a prospective, randomized, phase III BMT–CTN 0702 trial showed that consolidation with VRD as post-ASCT intervention did not improve PFS or OS in both standard and high-risk patients.…”

Section: Consolidation Therapy Post-asctmentioning

confidence: 99%

Stem-cell transplantation in multiple myeloma: how far have we come?

Soekojo

Kumar

2019

Therapeutic Advances in Hematology

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High-dose therapy (HDT) and autologous stem-cell transplantation (ASCT) has historically been an essential part of multiple myeloma (MM) management since early studies demonstrated its efficacy in relapsed disease, and subsequent phase III trials demonstrated better responses and improved survival with this modality compared with standard chemotherapy. With further advances in the MM treatment landscape, including the development of potent novel agents, there has been an increasing debate around various aspects of ASCT, including the optimal timing, role of single versus tandem ASCT, and the practice of consolidation and maintenance therapy post-ASCT. Routine incorporation of the novel agents at each of the treatment phases, induction, consolidation when used, and maintenance has led to better responses as reflected by increasing rates of minimal residual disease (MRD) negativity, longer progression-free survival (PFS) with improvement in overall survival (OS) and in some of the trials. The phase III trials over the last decade have provided significant clarity on the current approach, and have raised important questions regarding the applicability of this modality in all patients. This review aims to summarize the latest literature in the field and discusses how these findings impact the practice of ASCT today.

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Results from two phase III studies of bortezomib (BTZ) consolidation vs observation (OBS) post-transplant in patients (pts) with newly diagnosed multiple myeloma (NDMM).

Cited by 12 publications

References 0 publications

Effects of single‐agent bortezomib as post‐transplant consolidation therapy on multiple myeloma‐related bone disease: a randomized phase II study

Effects of single‐agent bortezomib as post‐transplant consolidation therapy on multiple myeloma‐related bone disease: a randomized phase II study

Consolidation therapy with the combination of bortezomib and lenalidomide (VR) without dexamethasone in multiple myeloma patients after transplant: Effects on survival and bone outcomes in the absence of bisphosphonates

Stem-cell transplantation in multiple myeloma: how far have we come?

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