Bortezomib, doxorubicin and intermediate-dose dexamethasone (iPAD) therapy for relapsed or refractory multiple myeloma: A multicenter phase 2 study

Yasushi Takamatsu, Kazutaka Sunami, Tsuyoshi Muta, Hiroaki Morimoto, Toshihiro Miyamoto, Masakazu Higuchi, Kimiharu Uozumi, Hiroyuki Hata, Kazuo Tamura

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Abstract

We previously conducted a phase 1 study of bortezomib, doxorubicin and intermediate-dose dexamethasone (iPAD) therapy and determined the optimal dose of bortezomib to be 1.0 mg/m2. We then conducted a multicenter phase 2 study in patients with relapsed or refractory myeloma. Bortezomib 1.0 mg/m2 was administered intravenously on days 1, 4, 8 and 11, in combination with intravenous doxorubicin 9 mg/m2 on days 1-4, and dexamethasone 20 mg orally on days 1-2, 4-5, 8-9 and 11-12 at a 3-week interval for six cycles. The primary endpoint of this study was the complete remission (CR) rate, and the secondary endpoints were progression-free survival (PFS), overall survival (OS) and toxicity. Twenty-seven patients, median age of 63, were enrolled. An overall response rate was 89 % with CR rate of 30 %. The median PFS time was 12.1 months, and the median OS time was not reached. One patient died of pneumonia. Although the incidence of hematological toxicities was high, these were transient and manageable. The most common non-hematological toxicity was sensory neuropathy; grade 3 toxicity was observed in six patients (22 %) and treatment was discontinued in four. We conclude that iPAD therapy is feasible, and shows efficacy by inducing high response rates and long response duration.

Original languageEnglish
Pages (from-to)179-185
Number of pages7
JournalInternational journal of hematology
Volume98
Issue number2
DOIs
Publication statusPublished - Aug 1 2013

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Multiple Myeloma
Doxorubicin
Dexamethasone
Disease-Free Survival
Survival
Therapeutics
Pneumonia
Bortezomib
Incidence

All Science Journal Classification (ASJC) codes

  • Hematology

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Bortezomib, doxorubicin and intermediate-dose dexamethasone (iPAD) therapy for relapsed or refractory multiple myeloma : A multicenter phase 2 study. / Takamatsu, Yasushi; Sunami, Kazutaka; Muta, Tsuyoshi; Morimoto, Hiroaki; Miyamoto, Toshihiro; Higuchi, Masakazu; Uozumi, Kimiharu; Hata, Hiroyuki; Tamura, Kazuo.

In: International journal of hematology, Vol. 98, No. 2, 01.08.2013, p. 179-185.

Research output: Contribution to journalArticle

Takamatsu, Yasushi ; Sunami, Kazutaka ; Muta, Tsuyoshi ; Morimoto, Hiroaki ; Miyamoto, Toshihiro ; Higuchi, Masakazu ; Uozumi, Kimiharu ; Hata, Hiroyuki ; Tamura, Kazuo. / Bortezomib, doxorubicin and intermediate-dose dexamethasone (iPAD) therapy for relapsed or refractory multiple myeloma : A multicenter phase 2 study. In: International journal of hematology. 2013 ; Vol. 98, No. 2. pp. 179-185.
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