title: Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma: a phase 1/2 Multiple Myeloma Research Consortium trial.
abstract: This phase 1/2 trial evaluated combination lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone (RVDD) in newly diagnosed multiple myeloma (MM) patients. Patients received RVDD at 4 dose levels, including the maximum tolerated dose (MTD). Patients with a very good partial response or better (≥ VGPR) after cycle 4 proceeded to autologous stem cell transplantation or continued treatment. The primary objectives were MTD evaluation and response to RVDD after 4 and 8 cycles. Seventy-two patients received a median of 4.5 cycles. The MTDs were lenalidomide 25 mg, bortezomib 1.3 mg/m(2), pegylated liposomal doxorubicin 30 mg/m(2), and dexamethasone 20/10 mg, as established with 3-week cycles. The most common adverse events were fatigue, constipation, sensory neuropathy, and infection; there was no treatment-related mortality. Response rates after 4 and 8 cycles were 96% and 95% partial response or better, 57% and 65% ≥ VGPR, and 29% and 35% complete or near-complete response, respectively. After a median follow-up of 15.5 months, median progression-free survival (PFS) and overall survival (OS) were not reached. The estimated 18-month PFS and OS were 80.8% and 98.6%, respectively. RVDD was generally well tolerated and highly active, warranting further study in newly diagnosed MM patients. This trial was registered at www.clinicaltrials.gov as NCT00724568.
authors: University of Michigan, Ann Arbor, MI 48109-5936, USA. ajakubow@umich.edu
authors: Andrzej J
authors: AJ
authors: Jakubowiak
authors: Kent A
authors: KA
authors: Griffith
authors: Donna E
authors: DE
authors: Reece
authors: Craig C
authors: CC
authors: Hofmeister
authors: Sagar
authors: S
authors: Lonial
authors: Todd M
authors: TM
authors: Zimmerman
authors: Erica L
authors: EL
authors: Campagnaro
authors: Robert L
authors: RL
authors: Schlossman
authors: Jacob P
authors: JP
authors: Laubach
authors: Noopur S
authors: NS
authors: Raje
authors: Tara
authors: T
authors: Anderson
authors: Melissa A
authors: MA
authors: Mietzel
authors: Colleen K
authors: CK
authors: Harvey
authors: Sandra M
authors: SM
authors: Wear
authors: Jennifer C
authors: JC
authors: Barrickman
authors: Craig L
authors: CL
authors: Tendler
authors: Dixie-Lee
authors: DL
authors: Esseltine
authors: Susan L
authors: SL
authors: Kelley
authors: Mark S
authors: MS
authors: Kaminski
authors: Kenneth C
authors: KC
authors: Anderson
authors: Paul G
authors: PG
authors: Richardson
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