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

• Published in: Journal of cancer research and clinical oncology Vol. 139; no. 3; pp. 499 - 508
• Main Authors: 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, Ali, Haifa Al, Niederwieser, Dietger
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.03.2013; Springer; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bendamustine Hydrochloride; Biological and medical sciences; Boronic Acids - administration & dosage; Boronic Acids - adverse effects; Bortezomib; Cancer Research; Drug Resistance, Neoplasm - drug effects; Drug therapy; Female; Hematologic and hematopoietic diseases; Hematology; Humans; Immunodeficiencies. Immunoglobulinopathies; Immunoglobulinopathies; Immunopathology; Internal Medicine; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Multiple myeloma; Multiple Myeloma - drug therapy; Multiple Myeloma - pathology; Nitrogen Mustard Compounds - administration & dosage; Nitrogen Mustard Compounds - adverse effects; Oncology; Original Paper; Pharmacology. Drug treatments; Prednisone - administration & dosage; Prednisone - adverse effects; Pyrazines - administration & dosage; Pyrazines - adverse effects; Recurrence; Retrospective Studies; Prednisone; Bendamustine; Bortezomib; Relapse/refractory; Multiple myeloma; Antineoplastic agent; Human; Corticosteroid; Immunopathology; Relapse; Treatment resistance; Patient; Malignant hemopathy; Myeloma; Alkylating agent; Immunoglobulinopathy; Analog; Proteasome inhibitor; Nitrogen mustard; Lymphoproliferative syndrome; Adrenal hormone; Dipeptides; Cancer
• ISSN: 0171-5216; 1432-1335
• DOI: 10.1007/s00432-012-1339-3

Introduction Bortezomib (Velcade ® ) is a proteasome inhibitor that has shown important clinical efficacy either as a single agent or in combination with other cytostatic agents in multiple myeloma (MM). In the present protocol, bortezomib was combined with other active substances like bendamustine and prednisone (BPV), in order to assess the efficacy and toxicity of the combination therapy in patients with relapsed or refractory MM. Methods Between January 2005 and December 2011, 78 patients with relapsed or refractory MM were treated with bendamustine 60 (−120) mg/m 2 on days 1 and 2, bortezomib 1.3 mg/m 2 on days 1, 4, 8 and 11, and prednisone 100 mg on days 1, 2, 4, 8 and 11. The median number of prior therapies was 2 with a wide range of 1–9. Thirty-three patients had pre-existing severe thrombocytopenia and/or neutropenia (WHO grade 3 or 4). Results A median number of two (range 1–7) BPV treatment cycles were given to the patients. The majority of the patients ( n  = 54; 69 %) responded after at least one cycle of chemotherapy with 3 CR, 10 nCR, 10 VGPR and 31 PR. Median PFS and OS for patients without severe hematological toxicities due to previous treatments ( n  = 45) were 11 and 50 months, respectively. Outcome for these patients was significantly better than that for patients with severe hematological toxicities (grade 3 or 4, n  = 33) with a PFS, and OS of 3 months ( p  < 0.05) and 5 months ( p  < 0.001), respectively. The regimen was well tolerated with few significant side effects in patients without severe hematological toxicities due to previous treatments. Summary These results indicate that the combination of bortezomib, bendamustine and prednisone is well tolerated in patients with relapsed or refractory MM.