Abstract

ABSTRACT Introduction The number of previous treatment lines and pre-treatment with Bortezomib (B) or lenalidomide (L) likely impacts the efficacy and tolerance of BBD in r/rMM. Patients and methods 71 pts with r/rMM have been enrolled. Median age: 65 yrs (range 40-86), male/female: 32/39, ISS stage I/II/III: 22, 29, and 20 pts, respectively. ECOG status 0/I/II: 37, 31, and 3 pts, respectively. Previous treatment lines: 1-2: 44, 3-6: 27 pts, 43 pts had previously been exposed to B and 37 to L. Full data documentation for response evaluation (≥2 cycles) is available for 65 pts. Treatment Benda 70 mg/m2 day 1 + 4, B 1.3 mg/m2 and Dex 20 mg on days 1, 4, 8 and 11, q 4 wks. Planned number of treatment cycles was 8, with discontinuation after 4 cycles in case of no response. K-M survival curves were compared using the log-rank test. Results After a median follow up of 7.1 mos, myeloma response (ORR: CR-PR) was noted in 38 (58.5%), CR/nCR in 11 (16.9%), VGPR in 10 (15.4%), PR in 17 (26.2%), MR in 11 (16.9%), and SD in 16 (24.6%) pts. Median time to response was 77 days. Tab 1 shows response rates and PFS in pts in regards to number of previous treatment lines and pre-exposure to B, L, and to both B and L. Median OS was not reached in any of the cohorts. All Pts 1-2 Treatment lines 3-6 Treatment lines Pre-exposure B L B and L ORR (%) 58.5% 61% 54% 76% 60% 44% PFS (mos) 12.2 13.0 7.8 12.2 5.9 6.0 G4 anemia, leucopenia and thrombopenia were reported in Disclosure H. Ludwig: Received honoraria for speakers bureau from Mundipharma, Celgene and Janssen-Cilag. Scientific research grants from Mundipharma and Janssen-Cilag. All other authors have declared no conflicts of interest.

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