Abstract
8012 Background: Bendamustine has promising activity in RRMM. This phase I (NCT02477215) study assessed the overall safety and activity of the combination of bendamustine with ixazomib & dexamethasone in pts. with MM pts. refractory to proteasome inhibitors and IMIDs. Methods: Design: Open label dose escalation (3+ 3 design) Doses: Bendamustine at escalating doses of 70, 80 and 90 mg/m2 on days 1,2 of each cycle with weekly ixazomib (4mg) and dexamethasone (40 mg) on days 1,8, 15 in 28-day cycles for up to 8 cycles in responders and 4 cycles if no anti-MM response. Primary end point was safety, maximum tolerated dose (MTD) and the recommended phase II (RP2D) dose. Results: As of Jan 2017, the phase I portion is complete (N= 15). The median age was 67 years with 5 (range: 2-10) median number of prior therapies. Prior therapies included bortezomib (100%), lenalidomide (100%), carfilzomib (47%), oprozomib (7%), thalidomide (7%), pomalidomide (7%) and 87% autotransplant. Five (33%) pts. completed their planned courses of therapy (4 or 8 cycles) and 3 (20%) continued on active therapy. Seven (47%) pts. discontinued study treatment (6 related to disease progression). Grade 3/ 4 adverse events were: lymphopenia (67%), neutropenia (27%), thrombocytopenia (33%), decreased WBC counts (13%), hematuria (7%), diarrhea (7%), anemia (7%), lung infection (7%), and skin ulceration (7%). Three (20%) pts. died of myeloma progression. In dose cohort 3 (bendamustine 90 mg/m2), 2 /6 pts. developed hematologic DLTs (neutropenia and thrombocytopenia) meeting MTD; RP2D was determined to be 80 mg/m2. The table below shows responses among pts receiving at least 2 cycles. The median duration of response was not reached at median follow up of 8 months (range, 4-13+) in responders. Conclusions: BID has an acceptable safety profile and a promising ORR of 45% and CBR of 73% in pts. with advanced double refractory MM. Clinical trial information: NCT02477215. [Table: see text]
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
