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Blood, 30 April 2009, Vol. 113, No. 18, pp. 4137-4143. Prepublished online as a Blood First Edition Paper on January 30, 2009; DOI 10.1182/blood-2008-10-184135. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2008-10-184135v1 113/18/4137    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Knop, S. Articles by Bargou, R. C. Search for Related Content PubMed PubMed Citation Articles by Knop, S. Articles by Bargou, R. C. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted October 16, 2008 Accepted January 8, 2009 Lenalidomide (Revlimid®), adriamycin and dexamethasone (RAD) in patients with relapsed and refractory multiple myeloma: A report from the German Myeloma Study Group DSMM (Deutsche Studiengruppe Multiples Myelom) Stefan Knop*, Christian Gerecke, Peter Liebisch, Max S. Topp, Uwe Platzbecker, Orhan Sezer, Christina Vollmuth, Karina Falk, Axel Glasmacher, Uwe Maeder, Hermann Einsele, and Ralf C. Bargou Department of Internal Medicine II, Division of Hematology and Medical Oncology, University Hospital Wuerzburg and Early Clinical Development Unit of CCCM, Wuerzburg, Germany Department of Hematology/Oncology, HELIOS Klinikum Berlin Buch, Berlin, Germany Deptartment of Internal Medicine III, University Hospital Ulm, Ulm, Germany Medizinische Klinik und Poliklinik I, Universitaetsklinikum "Carl Gustav Carus", Dresden, Germany Department of Hematology and Oncology, Charite University Hospital, Berlin, Germany Celgene Germany GmbH, Munich, Germany CCCM Wuerzburg, Wuerzburg, Germany * Corresponding author; email: knop_s{at}klinik.uni-wuerzburg.de. We conducted a phase I/II trial combining lenalidomide (Revlimid®; R) with adriamycin (A) and dexamethasone (D) for relapsed and relapsed-refractory myeloma to determine tolerability and efficacy of this novel regimen, RAD, delivered for six 28-day cycles. Sixty-nine intensively pretreated patients with a median age of 65 (range, 46 to 77) years were enrolled. Using pegfilgrastim (G), MTD was formally not reached at the highest dose level (R 25 mg d 1 - 21; A 9 mg/m2 i.v. d1-4; and D 40 mg d 1-4 and 17-20; 5+G) which was then used to determine efficacy. Grades 3/4 neutropenia and thrombocytopenia were seen in 48% and 38% of pts, respectively. Thromboembolic events occurred in 4.5% and severe infections in 10.5% of subects. On an intent-to treat analysis, ORR was 73% for the whole study and 77% including 74% CR+VGPR for dose level 5+G. Response rates and progression-free survival did not differ between relapsed and relapsed-refractory subjects. Deletion of chromosome 17p and elevated 2-microglobulin were associated with significantly inferior response and shortened time to progression. In conclusion, RAD induces substantial and durable remission with an acceptable toxicity profile in patients with relapsed and relapsed-refractory myeloma. This trial was registered at www.ClinicalTrials.gov as # NCT00306813 CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: D. Reece, K. W. Song, T. Fu, B. Roland, H. Chang, D. E. Horsman, A. Mansoor, C. Chen, E. Masih-Khan, Y. Trieu, et al. Influence of cytogenetics in patients with relapsed or refractory multiple myeloma treated with lenalidomide plus dexamethasone: adverse effect of deletion 17p13 Blood, July 16, 2009; 114(3): 522 - 525. [Abstract] [Full Text] [PDF]

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