Combined bendamustine, prednisone and bortezomib (BPV) in patients with relapsed or refractory multiple myeloma

Pönisch, Wolfram; Bourgeois, Malvina; Moll, Barbara; Heyn, Simone; Jäkel, Nadja; Wagner, Ina; Rohrberg, Robert; Hurtz, Hans-Jürgen; Schmalfeld, Marion; Aßmann, Michael; Edelmann, Thomas; Mohren, Martin; Hoffmann, Franz Albert; Becker, Cornelia; Schwarzer, Andreas; Schönfelder, Uta; Zehrfeld, Thomas; Hensel, Gerald; Löschcke, Kerstin; Krahl, Rainer; Al-Ali, Haifa Kathrin; Niederwieser, Dietger

doi:10.1007/s00432-012-1339-3

Cited by 31 publications

(31 citation statements)

References 25 publications

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“…ORR: 65–75%) that have evaluated bendamustine combined with bortezomib and steroids. 33, 34, 35, 36 Despite differences in patient populations, median TTP/PFS of our patients previously treated with 1–2 lines of therapy (17 months, 65% at 1 year) are comparable to those reported by Ludwig et al 34 (13 months) and Rodon et al 35 (67% at 1 year). The median TTP/PFS achieved with BVD is also similar to the 8- to 9.5-month TTP/PFS duration achieved by Hrusovsky and Heidtmann 33 and Ludwig et al 34 in patients with more advanced disease.…”

Section: Discussionsupporting

confidence: 77%

“…25 After phase I assessments, 26 several trials evaluated bendamustine alone or combined with new drugs in patients with MM. 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 Bendamustine demonstrated a predictable and manageable toxicity profile, mainly comprising neutropenia, thrombocytopenia, mucositis and infections. Moreover, its pharmacokinetics were unaffected by impaired renal function, which is common among MM patients.…”

Section: Introductionmentioning

confidence: 99%

“…37 However, several doses and schedules of bendamustine plus bortezomib had already been used in phase II studies, with variable results and toxicities, before publication of these phase I results. 33, 34, 35, 36 …”

Section: Introductionmentioning

confidence: 99%

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Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study

Offidani

Corvatta²,

Maracci

et al. 2013

Blood Cancer Journal

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Bendamustine demonstrated synergistic efficacy with bortezomib against multiple myeloma (MM) cells in vitro and seems an effective treatment for relapsed-refractory MM (rrMM). This phase II study evaluated bendamustine plus bortezomib and dexamethasone (BVD) administered over six 28-day cycles and then every 56 days for six further cycles in patients with rrMM treated with ⩽4 prior therapies and not refractory to bortezomib. The primary study end point was the overall response rate after four cycles. In total, 75 patients were enrolled, of median age 68 years. All patients had received targeted agents, 83% had 1–2 prior therapies and 33% were refractory to the last treatment. The response rate⩾partial response (PR) was 71.5% (16% complete response, 18.5% very good PR, 37% partial remission). At 12 months of follow-up, median time-to-progression (TTP) was 16.5 months and 1-year overall survival was 78%. According to Cox regression analysis, only prior therapy with bortezomib plus lenalidomide significantly reduced TTP (9 vs 17 months; hazard ratio=4.5; P=0.005). The main severe side effects were thrombocytopenia (30.5%), neutropenia (18.5%), infections (12%), neuropathy (8%) and gastrointestinal and cardiovascular events (both 6.5%). The BVD regimen is feasible, effective and well-tolerated in difficult-to-treat patients with rrMM.

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Section: Discussionsupporting

confidence: 77%

Section: Introductionmentioning

confidence: 99%

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Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study

Offidani

Corvatta²,

Maracci

et al. 2013

Blood Cancer Journal

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“…Hrusovsky and Heidtmann 17 reported in an abstract a RR of 72.5% and, when MRs were included, of 85% obtained in 40 patients with a median of 4 prior treatment lines. Pönisch et al 18 studied a heterogeneous group of patients with good or restricted bone marrow function and observed an RR of 69%.…”

Section: Discussionmentioning

confidence: 99%

Bendamustine-bortezomib-dexamethasone is an active and well-tolerated regimen in patients with relapsed or refractory multiple myeloma

Ludwig

Kasparu

Leitgeb

et al. 2014

Blood

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Key Points• Bendamustine-bortezomibdexamethasone is active and well tolerated in relapsed/ refractory myeloma.Bendamustine with bortezomib and dexamethasone was evaluated in 79 patients with relapsed/refractory multiple myeloma. Median age was 64 years, and patients had a median of 2 prior treatment lines (range, 1 to 6 lines). Bendamustine 70 mg/m 2 days 1 and 4; bortezomib 1.3 mg/m 2 intravenously days 1, 4, 8, and 11; and dexamethasone 20 mg days 1, 4, 8, and 11 once every 28 days was given for up to 8 cycles. Primary end point was overall response rate (ORR). Secondary end points were progression-free survival (PFS), overall survival, time to response, and toxicity. ORR was 60.8%, and when minor responses were included, 75.9%. Median time to response was 31 days. ORR rate was similar in patients previously exposed to bortezomib, lenalidomide, and bortezomib plus lenalidomide. PFS was 9.7 and OS was 25.6 months. Multivariate analysis showed high lactate dehydrogenase, ‡3 prior treatment lines, and low platelet counts correlating with short survival. Grade 3/4 thrombocytopenia was noted in 38%, and grade 3/4/5 infections were noted in 23%. Grade £2 polyneuropathy increased from 19% at baseline to 52% at cycle 8 and grade 4, from 0% to 7%. Bendamustine-bortezomib-dexamethasone is active and well tolerated in patients with relapsed/refractory myeloma. This trial was registered in the EudraCT database as -006421-13. (Blood. 2014 123(7):985-991)

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“…ORR was 69% with PFS of 11 months, superior to not-heavily pretreated patients [27]. BVP was effective also in the cohort of 36 patients with light chain-induced renal failure (creatinine clearance <60 mL/min), achieving ORR 67% [28].…”

Section: Novel Alkylatorsmentioning

confidence: 99%

Salvage Therapy of Multiple Myeloma: The New Generation Drugs

Romano

Conticello

Cavalli

et al. 2014

BioMed Research International

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During the past decade, overall results of treatment of multiple myeloma (MM) have been improved and survival curves are now significantly better with respect to those obtained with historical treatment. These improvements are linked to a deeper knowledge of the biology of disease and to the introduction in clinical practice of drugs with different mechanism of action such as proteasome inhibitors and immunomodulatory drugs (IMiDs). However, MM remains in most cases an incurable disease. For patients who relapse after treatment with novel agents, the prognosis is dismal and new drugs and therapeutic strategies are required for continued disease control. In this review, we summarize new insights in salvage therapy for relapsed/refractory MM as emerging from recent clinical trials exploring the activity of bendamustine, new generation proteasome inhibitors, novel IMiDs, monoclonal antibodies, and drugs interfering with growth pathways.

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Combined bendamustine, prednisone and bortezomib (BPV) in patients with relapsed or refractory multiple myeloma

Cited by 31 publications

References 25 publications

Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study

Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study

Bendamustine-bortezomib-dexamethasone is an active and well-tolerated regimen in patients with relapsed or refractory multiple myeloma

Salvage Therapy of Multiple Myeloma: The New Generation Drugs

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