Prospective, Randomized Study of Single Compared With Double Autologous Stem-Cell Transplantation for Multiple Myeloma: Bologna 96 Clinical Study

Cavo, Michèle; Tosi, Patrizia; Zamagni, Elena; Cellini, Claudia; Tacchetti, Paola; Patriarca, Francesca; Raimondo, Francesco Di; Volpe, E; Ronconi, Sonia; Cangini, Delia; Narni, Franco; Carubelli, Affra; Masini, Luciano; Catalano, Lucio; Fiacchini, M; Vivo, Antonio De; Gozzetti, Alessandro; Lazzaro, Antonio; Tura, S; Baccarani, Michele

doi:10.1200/jco.2006.10.2509

Cited by 350 publications

(261 citation statements)

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“…Such high CR and !VGPR rates are important, because it has been demonstrated that CR rates and a !VGPR rates, both postinduction and post-ASCT, are prognostic for improved outcomes. 8,[22][23][24][25][26][27] To date, this is the largest study, with the longest follow-up, to assess BTD induction therapy. The 25-month follow-up allowed an analysis of post-ASCT outcomes to assess the impact of the response and CR rates achieved; and, to our knowledge, this is the first study to report time-to-events data after BTD induction.…”

Section: Discussionmentioning

confidence: 99%

“…The 25-month follow-up allowed an analysis of post-ASCT outcomes to assess the impact of the response and CR rates achieved; and, to our knowledge, this is the first study to report time-to-events data after BTD induction. Reflecting the association between CR and !VGPR rates and improved outcomes, 8,[22][23][24][25][26][27] the time-to-events data were promising. In addition, analysis of OS post-transplantation according to response to BTD induction therapy suggested a trend toward improved survival in patients who achieved a !VGPR compared with those who did not, although the small number of patients who did not proceed to HDT-ASCT limits interpretation of this result.…”

Section: Discussionmentioning

confidence: 99%

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Bortezomib, thalidomide, and dexamethasone as induction therapy for patients with symptomatic multiple myeloma

Kaufman

Nooka

Vrana³

et al. 2010

Cancer

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BACKGROUND: This single-center retrospective study determined the efficacy of bortezomib, thalidomide, and dexamethasone (BTD) as induction for patients with multiple myeloma (MM) who were eligible for autologous stem cell transplantation (ASCT). METHODS: Patients with symptomatic MM who had received BTD induction before stem cell collection at Winship Cancer Institute were included. BTD induction comprised up to 8 3-week cycles of bortezomib 1.3 mg/m 2 on Days 1, 4, 8, and 11; thalidomide 100 mg daily; and dexamethasone 40 mg on Days 1 through 4 and Days 9 through 12. Stem cell mobilization involved granulocyte-colony-stimulating factor and/or cyclophosphamide. Response was assessed according to European Group for Blood and Marrow Transplantation criteria. RESULTS: Review of medical records identified 44 eligible patients (34 patients who were treated in the front-line setting and 10 patients who were treated for recurrent disease) who received a median of 4 BTD cycles. The overall response rate (ORR) was 91%, which included a greater than or equal to very good partial response (!VGPR) rate of 57% (including 20% stringent complete responses/complete response [sCR/CR] rate). In front-line patients, the ORR was 94%, which included a 56% !VGPR rate (24% sCR/CR). The median CD34-positive stem cell collection was 10.67 Â 10 6 /kg. The ORR after ASCT in 34 patients who were evaluable for response was 100%, including a 76% !VGPR rate (53% sCR/CR). Among all 44 patients, the median progression-free survival (PFS) was 27.4 months. The median overall survival (OS) was not reached after a median follow-up of 25 months, and the 2-year OS rate was 82%. There were no significant differences in PFS (27.4 months vs 23.5 months) or in 2-year survival (80% vs 90%) between patients who did and did not undergo ASCT, respectively. Twenty patients (45%) developed neuropathy, including 4 (9%) with grade 3 neuropathy episodes, and 1 patient developed deep vein thrombosis. CONCLUSIONS: BTD was highly effective and well tolerated as induction for MM patients who were eligible for ASCT. Long-term outcomes appeared to be similar with or without ASCT consolidation. Cancer 2010;116:3143-51.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Bortezomib, thalidomide, and dexamethasone as induction therapy for patients with symptomatic multiple myeloma

Kaufman

Nooka

Vrana³

et al. 2010

Cancer

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“…Further, in a Spanish randomized trial, patients responding to induction therapy failed to benefit from ASCT trial, suggesting that the greatest benefit from early ASCT may be mainly among the small proportion of patients with disease refractory to induction therapy [92]. Two randomized trials have found benefit with tandem (double) versus single ASCT, with the benefit primarily seen in patients failing to achive CR or VGPR with the first ASCT [93,94]. Two other randomized trials, however, have yet to show significant improvement in OS with double ASCT [95,96].…”

Section: Role Of Hematopoietic Stem Cell Transplantationmentioning

confidence: 99%

Multiple myeloma: 2013 update on diagnosis, risk‐stratification, and management

2013

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Disease overviewMultiple myeloma accounts for approximately 10% of hematologic malignancies.DiagnosisThe diagnosis requires 10% or more clonal plasma cells on bone marrow examination or a biopsy proven plasmacytoma plus evidence of associated end‐organ damage. In addition, the presence of 60% or more clonal plasma cells in the marrow is also considered as myeloma regardless of the presence or absence of end‐organ damage.Risk stratificationIn the absence of concurrent trisomies, patients with 17p deletion, t(14;16), and t(14;20) are considered to have high‐risk myeloma. Patients with t(4;14) translocation are considered intermediate‐risk. All others are considered as standard‐risk.Risk‐adapted initial therapyStandard‐risk patients can be treated with lenalidomide plus low‐dose dexamethasone (Rd), or a bortezomib‐containing triplet such as bortezomib, cyclophosphamide, dexamethasone (VCD). Intermediate‐risk and high‐risk patients require a bortezomib‐based triplet regimen. In eligible patients, initial therapy is given for approximately 4 months followed by autologous stem cell transplantation (ASCT). Standard‐risk patients can opt for delayed ASCT if stem cells can be cryopreserved. In patients are not candidates for transplant, initial therapy is given for approximately 12–18 months.Maintenance therapyAfter initial therapy, lenalidomide maintenance is considered for standard‐risk patients who are not in very good partial response or better, while maintenance with a bortezomib‐based regimen should be considered in pateints with intermediate or high‐risk myeloma.Management of refractory diseasePatients with indolent relapse can be treated first with two‐drug or three‐drug combinations. Patients with more aggressive relapse often require therapy with a combination of multiple active agents. Am. J. Hematol. 88:225–235, 2013. © 2013 Wiley Periodicals, Inc.

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“…Most randomised trials comparing single with tandem ASCT have shown no benefit in overall survival from tandem stem cell transplantation (Attal et al, 2003;Fermand et al, 2005b;Cavo et al, 2007;Mai et al, 2016;Sonneveld et al, 2007; reviewed by Kumar et al, 2009). Many of these trials utilised non-standard conditioning regimens (e.g.…”

Section: Tandem Transplantsmentioning

confidence: 99%

“…Many of these trials utilised non-standard conditioning regimens (e.g. oral busulfan or TBI) which have since been shown to be inferior to standard mel200 (Attal et al, 2003;Fermand et al, 2005b;Cavo et al, 2007;Sonneveld et al, 2007). However the GMMG-HD2 trial, which used tandem standard mel200 ASCT, showed no difference in survival (Mai et al, 2016).…”

Section: Tandem Transplantsmentioning

confidence: 99%

Augmenting Autologous Stem Cell Transplantation to Improve Outcomes in Myeloma

Maybury

Cook

Pratt

et al. 2016

Biology of Blood and Marrow Transplantation

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SummaryConsolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is the standard of care for transplant eligible patients with multiple myeloma, based on randomised trials showing improved progression free survival with autologous transplantation following combination chemotherapy induction. These trials were performed before novel agents were introduced, and subsequently combinations of immunomodulatory drugs (IMiDs) and proteasome inhibitors as induction therapy have significantly improved rates and depth of response. Ongoing randomised trials are testing whether conventional autologous transplantation continues to improve responses following novel agent induction. While these results are awaited, it is important to review strategies for improving outcomes following ASCT. Conditioning prior to ASCT with higher doses of melphalan, and combinations of melphalan with other agents, including radiopharmaceuticals have been explored. Tandem ASCT, consolidation and maintenance therapy following ASCT have been investigated in phase III trials. Experimental cellular therapies using ex vivo primed dendritic cells , ex vivo expanded autologous lymphocytes, KIR-mismatched allogeneic NK cells, and genetically modified T cells are also in phase I trials to augment ASCT. This review summarises these strategies and highlights the importance of exploring strategies to augment ASCT even in the era of novel agent induction.

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Prospective, Randomized Study of Single Compared With Double Autologous Stem-Cell Transplantation for Multiple Myeloma: Bologna 96 Clinical Study

Cited by 350 publications

References 37 publications

Bortezomib, thalidomide, and dexamethasone as induction therapy for patients with symptomatic multiple myeloma

Bortezomib, thalidomide, and dexamethasone as induction therapy for patients with symptomatic multiple myeloma

Multiple myeloma: 2013 update on diagnosis, risk‐stratification, and management

Augmenting Autologous Stem Cell Transplantation to Improve Outcomes in Myeloma

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