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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.

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CLINICAL TRIALS AND OBSERVATIONS

Lenalidomide, 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 Knop1,*, Christian Gerecke2,*, Peter Liebisch3, Max S. Topp1, Uwe Platzbecker4, Orhan Sezer5, Christina Vollmuth1, Karina Falk6, Axel Glasmacher6, Uwe Maeder7, Hermann Einsele1, and Ralf C. Bargou1

1 Department of Internal Medicine II, Division of Hematology and Medical Oncology, University Hospital Wuerzburg and Early Clinical Development Unit of Comprehensive Cancer Center Mainfranken (CCCM), Wuerzburg; 2 Department of Hematology/Oncology, HELIOS Klinikum Berlin Buch, Berlin; 3 Department of Internal Medicine III, University Hospital, Ulm; 4 Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus, Dresden; 5 Department of Hematology and Oncology, Charité University Hospital, Berlin; 6 Celgene Germany, Munich; and 7 CCCM, Wuerzburg, Germany

We conducted a phase 1/2 trial combining lenalidomide (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. A total of 69 intensively pretreated patients with a median age of 65 years (range, 46-77 years) were enrolled. Using pegfilgrastim (G), the maximum tolerated dose (MTD) was formally not reached at the highest dose level (R, 25 mg on days 1-21; A, 9 mg/m2 intravenously on days 1-4; and D, 40 mg on days 1-4 and 17-20; dose level 5+G), which was then used to determine efficacy. Grades 3/4 neutropenia and thrombocytopenia were seen in 48% and 38% of patients, respectively. Thromboembolic events occurred in 4.5% and severe infections in 10.5% of patients. On an intent-to treat analysis, overall response rate (ORR) was 73% for the whole study and 77% including 74% complete response (CR) plus very good partial response (VGPR) for dose level 5+G. Response rates and progression-free survival did not differ between relapsed and relapsed-refractory patients. Deletion of chromosome 17p and elevated β2-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 no. NCT00306813 [ClinicalTrials.gov] .


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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.
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