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BENDAMUSTINE-BORTEZOMIB-DESAMETASONE (BVD) IN THE MANAGEMENT OF RELAPSED AND REFRACTORY MULTIPLE MYELOMA : A REAL-LIFE EXPERIENCE
Author(s): ,
Claudio Cerchione
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Lucio Catalano
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Anna Emanuele Pareto
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Santina Basile
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Luana Marano
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Ilaria Peluso
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Luigia Simeone
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Orsola Vitagliano
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
,
Salvatore Palmieri
Affiliations:
Hematology,AORN A.Cardarelli,Napoli,Italy
,
Felicetto Ferrara
Affiliations:
Hematology,AORN A.Cardarelli,Napoli,Italy
Fabrizio Pane
Affiliations:
Hematology,Ematologia e trapianto/au federico ii,Napoli,Italy
(Abstract release date: 05/19/16) EHA Library. Cerchione C. 06/09/16; 134873; PB1973
Dr. Claudio Cerchione
Dr. Claudio Cerchione
Contributions
Abstract
Abstract: PB1973

Type: Publication Only

Background
Bendamustine is a bifunctional alkylating agent, with low toxicity, proved to be effective in relapsed, refractory and in new diagnosed Multiple Myeloma (MM).

Aims
It has been evaluated efficacy and tolerance of Bendamustine, in combination with bortezomib-dexamethasone (BVD) in patients with relapsed and refractory MM (rrMM), whose prognosis is particularly severe. A regional retrospective real-life analysis of patients with rrMM who had been treated with BVD as salvage therapy has been performed.

Methods
47 patients (25 M/22 F), with rrMM, median age at diagnosis 58.4 years (r. 36-82), median age at start of treatment 61.3 years (r.37-83) treated with several lines of treatments (median 6, r. 2-11), every refractory to all the drugs previously received (also Bortezomib), received BVD (Bendamustine 90 mg/sqm days 1,2; Bortezomib 1.3 mg/sqm days 1,4,8,11, Dexamethasone 20 mg days 1,2,4,5,8,9,11,12, Pegfilgrastim day +4) every 28 days, until progression. ISS was equally distributed, and cytogenetic was evaluable in 9 patients, and in particular one del13q and one t(11;14). All the patients had previously been treated with schedule containing bortezomib and IMIDs, 90% of them with melphalan, 77% with cyclophosphamide, 34% with antracyclines and 30% had also received radiotherapy. 58% of them had undergone at least to a single auSCT. All patients were relapsed and refractory to last therapies received before BVD.

Results
Bendamustine was well tolerated, with grade 3 transfusion-dependent anemia in 29% of patients, and 41% grade 3 neutropenia (no ospedalization was required, no septic shocks were observed). No severe extrahematologic toxicity was observed, only grade 1 gastrointestinal side effect (nausea), treated by common antiemetic drugs.According to IMWG, after a median follow-up of 9 months (r.2-36), ORR was 57% (27/47 : 2 CR, 3 VGPR, 14 PR, 8 MR) with 8 PD and 12 patients in SD, which can be considered as an impressive result in this subset of rrMM patients. In particular, for 6 patients, BVD was, after having achieved a PR, a bridge to second auSCT, and for one patient a bridge to auSCT.Median time to response was 1.3 months (r.1-3), median OS from diagnosis was 61.4 months (range 6-151), median OS from start of Bendamustine was 9.3 months (range 2-36).

Conclusion
BVD has shown significant efficacy in a particular severe setting of patients, relapsed and refractory to all avaiable therapeutic resources, and in particular cases it could be considered as a bridge to a second autologous or allogenic BMT.

Session topic: E-poster

Keyword(s): Bendamustine, Bortezomib, Myeloma
Abstract: PB1973

Type: Publication Only

Background
Bendamustine is a bifunctional alkylating agent, with low toxicity, proved to be effective in relapsed, refractory and in new diagnosed Multiple Myeloma (MM).

Aims
It has been evaluated efficacy and tolerance of Bendamustine, in combination with bortezomib-dexamethasone (BVD) in patients with relapsed and refractory MM (rrMM), whose prognosis is particularly severe. A regional retrospective real-life analysis of patients with rrMM who had been treated with BVD as salvage therapy has been performed.

Methods
47 patients (25 M/22 F), with rrMM, median age at diagnosis 58.4 years (r. 36-82), median age at start of treatment 61.3 years (r.37-83) treated with several lines of treatments (median 6, r. 2-11), every refractory to all the drugs previously received (also Bortezomib), received BVD (Bendamustine 90 mg/sqm days 1,2; Bortezomib 1.3 mg/sqm days 1,4,8,11, Dexamethasone 20 mg days 1,2,4,5,8,9,11,12, Pegfilgrastim day +4) every 28 days, until progression. ISS was equally distributed, and cytogenetic was evaluable in 9 patients, and in particular one del13q and one t(11;14). All the patients had previously been treated with schedule containing bortezomib and IMIDs, 90% of them with melphalan, 77% with cyclophosphamide, 34% with antracyclines and 30% had also received radiotherapy. 58% of them had undergone at least to a single auSCT. All patients were relapsed and refractory to last therapies received before BVD.

Results
Bendamustine was well tolerated, with grade 3 transfusion-dependent anemia in 29% of patients, and 41% grade 3 neutropenia (no ospedalization was required, no septic shocks were observed). No severe extrahematologic toxicity was observed, only grade 1 gastrointestinal side effect (nausea), treated by common antiemetic drugs.According to IMWG, after a median follow-up of 9 months (r.2-36), ORR was 57% (27/47 : 2 CR, 3 VGPR, 14 PR, 8 MR) with 8 PD and 12 patients in SD, which can be considered as an impressive result in this subset of rrMM patients. In particular, for 6 patients, BVD was, after having achieved a PR, a bridge to second auSCT, and for one patient a bridge to auSCT.Median time to response was 1.3 months (r.1-3), median OS from diagnosis was 61.4 months (range 6-151), median OS from start of Bendamustine was 9.3 months (range 2-36).

Conclusion
BVD has shown significant efficacy in a particular severe setting of patients, relapsed and refractory to all avaiable therapeutic resources, and in particular cases it could be considered as a bridge to a second autologous or allogenic BMT.

Session topic: E-poster

Keyword(s): Bendamustine, Bortezomib, Myeloma

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