Journal
EUROPEAN JOURNAL OF HAEMATOLOGY
Volume 95, Issue 5, Pages 426-435Publisher
WILEY
DOI: 10.1111/ejh.12509
Keywords
multiple myeloma; bortezomib; pegylated liposomal doxorubicin; cyclophosphamide
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Funding
- Millennium Pharmaceuticals Inc.
- Janssen Biotec Inc.
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We conducted a phase 1/2 trial evaluating the combination of cyclophosphamide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone (CVDD) for newly diagnosed multiple myeloma (MM). The primary objective of the phase 1 was to evaluate the safety and tolerability of maximum planned dose (MPD) and the phase 2 was to assess the overall response rate. Patients received 6-8 cycles of CVDD at four dose levels. There were no dose-limiting toxicities. The MPD was cyclophosphamide 750mg/m(2) IV on day 1, bortezomib 1.3mg/m(2) IV on days 1, 4, 8, 11, pegylated liposomal doxorubicin 30mg/m(2) IV on day 4, and dexamethasone 20mg orally on the day of and after bortezomib (21-d cycle). Forty-nine patients were treated at the MPD of which 22% had high-risk myeloma. The most common grade 3 toxicities included myelosuppression, infection, and fatigue. Overall response and complete response rates were 91% and 26% in standard-risk, and 100% and 58% in high-risk cohort, respectively. After a median follow-up of 34months, the median progression-free survival was 31.3months. The 2-yr overall survival was 91.1% in the standard-risk and 88.9% in the high-risk cohort, respectively. CVDD regimen was well tolerated and was highly active in newly diagnosed MM.
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