Lenalidomide in combination with bendamustine and prednisolone in relapsed/refractory multiple myeloma: results of a phase 2 clinical trial (OSHO-#077)

Beck, Juliane; Schwarzer, Andreas; Gläser, Dietrich; Mügge, Lars-Olof; Uhlig, Jens; Heyn, Simone; Kragl, Brigitte; Mohren, Martin; Hoffmann, Franz; Lange, Thoralf; Schliwa, Thomas; Zehrfeld, Thomas; Becker, Cornelia; Kreibich, Ute; Winkelmann, Cornelia; Edelmann, Thomas; Andrea, Marc; Bill, Marius; Jentzsch, Madlen; Schwind, Sebastian
December 2017
Journal of Cancer Research & Clinical Oncology;Dec2017, Vol. 143 Issue 12, p2545
Academic Journal
Introduction: While lenalidomide monotherapy is established for relapsed and/or refractory multiple myeloma (MM) treatment, combination therapies including lenalidomide are still under investigation in a number of phase 2/3 studies. In the current study, a treatment regime of lenalidomide (Revlimid), bendamustine and prednisolone (RBP) was tested in patients with relapsed/refractory MM. Methods: In the previously completed phase 1 study RBP with a dose of 75 mg/m bendamustine days 1-2, prednisolone 100 mg days 1-4 and 25 mg lenalidomide days 1-21 was well tolerated. Results: Between July 2011 and September 2013, 25 patients were included in this analysis. The median number of previous treatments was 1 (range 1-2). Twenty-two patients (88%) responded after at least two cycles of RBP (one sCR, five nCR, eight VGPR and eight PR). The median time to first haematological response was 28 days, and median time to best response was 56 days. Due to increased haematological toxicity a dose reduction in most patients required in subsequent cycles of therapy. The median progression-free and overall survival was 22 and 38 months, respectively. Summary: In conclusion RBP is a highly effective therapy for patients with relapsed/refractory MM. In contrast to our phase 1 study, dose reduction was necessary in many patients because of haematological toxicity.


Related Articles

  • Thalidomide as an Antiangiogenic Drug in the Treatment of Multiple Myeloma. Ribatti, Domenico; Vacca, Angelo // Letters in Drug Design & Discovery;Apr2004, Vol. 1 Issue 2, p135 

    Experimental studies have demonstrated that thalidomide, a drug developed as a sedative, has antitumoral properties. Its broad spectrum of actions besides its antiangiogenic potential, includes immunomodulatory properties, antiinflammatory actions and direct effect on tumor cells and their...

  • Thalidomide.  // Reactions Weekly;4/24/2004, Issue 998, p16 

    Presents information on a study on the occurrence of atrial thrombosis in the course of multiple myeloma treated with thalidomide, by F. Barbou et al., published in the October 2003 issue of the "Archives des Maladies du Coeur et des Vaisseaux" journal.

  • Steven's Johnson syndrome with toxic epidermal necrolysis due to thalidomide in a case of multiple myeloma. Das, Anupam; Sil, Amrita; Mishra, Vivek; Kanti Das, Nilay // Indian Journal of Pharmacology;Sep/Oct2014, Vol. 46 Issue 5, p557 

    Thalidomide developed in 1954 for morning sickness had proven to be a teratogen and hence was withdrawn from market. Resurgence of thalidomide began as an immunomodulator when it was shown to be effective in the management of multiple myeloma and many conditions like erythema nodosum leprosum,...

  • Development of leukocytoclastic vasculitis in a patient with multiple myeloma during treatment with thalidomide. Witzens, Mathias; Moehler, Thomas; Neben, Kai; Fruehauf, Stefan; Hartschuh, Wolfgang; Ho, Anthony D.; Goldschmidt, Hartmut // Annals of Hematology;Jul2004, Vol. 83 Issue 7, p467 

    Thalidomide, an agent with antiangiogenic and immunomodulatory properties, is therapeutically effective in multiple myeloma, leprosy, and autoimmune diseases. The most common clinical toxicities of thalidomide are constipation, neuropathy, fatigue, sedation, rash, tremor, and edema. We here...

  • Bortezomib, doxorubicin, and dexamethasone combination therapy followed by thalidomide and dexamethasone consolidation as a salvage treatment for relapsed or refractory multiple myeloma: analysis of efficacy and safety. Sung Sook Lee; Cheolwon Suh; Bong-Seog Kim; Jooseop Chung; Young-Don Joo; Hun-Mo Ryoo; Young Rok Do; Jong-Youl Jin; Hye Jin Kang; Gyeong-Won Lee; Moon Hee Lee; Hyeok Shim; Kihyun Kim; Sung-Soo Yoon; Soo Mee Bang; Ho Young Kim; Je-Jung Lee; Jinny Park; Dong Soon Lee; Jae-Hoon Lee // Annals of Hematology;Sep2010, Vol. 89 Issue 9, p905 

    We conducted a phase 2 study with bortezomib, doxorubicin, and dexamethasone (PAD) followed by thalidomide and dexamethasone (TD) in patients with relapsed multiple myeloma (MM). Forty patients were enrolled between November 2005 and October 2007, with follow-up continuing until January 2009....

  • Long term use of thalidomide: Safe and effective. Sharma, A.; Raina, V.; Uppal, G.; Kumar, R.; Grover, J. // Indian Journal of Cancer;Jul-Sep2007, Vol. 44 Issue 3, p108 

    To assess the efficacy and safety of high dose thalidomide therapy for longer duration of time in relapsed or refractory Multiple Myeloma (MM) patients. Materials and Methods : Twelve relapsed/refractory MM patients (7 Males, 5 Females), who received thalidomide for more than 2 years were...

  • Tumour lysis syndrome: case report.  // Reactions Weekly;5/15/2004, Issue 1001, p14 

    Presents a case report on the side effects of thalidomide in an elderly patient with progressive high-burden nonsecretory multiple myeloma. Reference to a study by N. Fuente and colleagues published in the March 2004 issue of "Annals of Oncology"; Development of tumor lysis syndrome;...

  • First-line thalidomide–dexamethasone therapy in preparation for autologous stem cell transplantation in young patients (<61 years) with symptomatic multiple myeloma. Abdelkefi, A.; Torjman, L.; Ben Romdhane, N.; Ladeb, S.; El Omri, H.; Ben Othman, T.; Elloumi, M.; Bellaj, H.; Lakhal, A.; Jeddi, R.; Aissaouï, L.; Saad, A.; Hsaïri, M.; Boukef, K.; Dellagi, K.; Ben Abdeladhim, A. // Bone Marrow Transplantation;Aug2005, Vol. 36 Issue 3, p193 

    Summary:Thalidomide–dexamethasone therapy was given in patients (<61 years) with previously untreated symptomatic multiple myeloma. The aim of this study was to assess the efficacy and toxicity of this combination as first-line therapy, and to determine its effect on stem cell collection...

  • The role of novel drugs in multiple myeloma. Dimopoulos, M. A.; Kastritis, E. // Annals of Oncology;Sep2008 Supplement 7, Vol. 19, p21 

    The article examines new agents and their combinations and their role in the treatment of multiple myeloma. It states that oral thalidomide-based regimens are the most common treatment for relapsed or refractory myeloma and the most widely used are the oral combinations of cyclophosphamide,...

  • Thalidomide in newly diagnosed multiple myeloma: influence of thalidomide treatment on peripheral blood stem cell collection yield. Breitkreutz, I.; Lokhorst, H. M.; Raab, M. S.; van der Holt, B.; Cremer, F. W.; Herrmann, D.; Glasmacher, A.; Schmidt-Wolf, I. G. H.; Blau, I. W.; Martin, H.; Salwender, H.; Haenel, A.; Sonneveld, P.; Goldschmidt, H. // Leukemia (08876924);Jun2007, Vol. 21 Issue 6, p1294 

    In a phase III randomized, multicenter study, the German-speaking Myeloma-Multicenter Group (GMMG) and the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON) group investigated the influence of thalidomide (Thal) on the outcome of peripheral blood stem cell (PBSC) collection in multiple...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics