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clinical / clinicalAPEX trial, pomalidomide, bortezomib phase III

Paul G. Richardson

保罗·理查德森

MD

🏢Dana-Farber Cancer Institute / Harvard Medical School(丹娜-法伯癌症研究所 / 哈佛医学院)🌐USA

Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center; RJ Corman Professor of Medicine, Harvard Medical SchoolJerome Lipper多发性骨髓瘤中心临床项目负责人及临床研究主任;哈佛医学院RJ Corman医学教授

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h-index
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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Paul G. Richardson, MD is Clinical Program Leader and Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, and holds the RJ Corman Professorship of Medicine at Harvard Medical School. He is one of the world's foremost clinical trialists in multiple myeloma, best known for leading the APEX trial — the landmark phase III study that established bortezomib's superiority over high-dose dexamethasone in relapsed/refractory myeloma and resulted in full FDA approval of bortezomib in 2005. Dr. Richardson subsequently spearheaded the clinical development of pomalidomide, leading phase I/II studies that defined its activity in double-refractory myeloma and the phase IIIb STRATUS trial that supported its FDA approval in 2013. He has served as principal investigator on dozens of pivotal myeloma trials spanning proteasome inhibitors, IMiDs, histone deacetylase inhibitors, and novel antibody-drug conjugates. A particular focus of his work has been defining optimal combination regimens and sequencing strategies for relapsed/refractory myeloma, including the VRd (bortezomib, lenalidomide, dexamethasone) backbone and carfilzomib-based triplets. Dr. Richardson has published more than 700 peer-reviewed manuscripts and lectures extensively at ASH, ASCO, and EHA congresses.

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🧪Research Fields 研究领域

APEX Trial — Phase III Bortezomib vs. Dexamethasone in Relapsed MyelomaAPEX试验——硼替佐米vs地塞米松III期复发骨髓瘤研究
Pomalidomide — Phase I/II Development and STRATUS Trial泊马度胺——I/II期研发与STRATUS试验
Proteasome Inhibitor and IMiD Combination Regimen Design蛋白酶体抑制剂与IMiD联合方案设计
Carfilzomib and Ixazomib Clinical Development卡非佐米与伊沙佐米临床开发
Stem Cell Transplantation Conditioning and Post-Transplant Consolidation in Myeloma骨髓瘤中造血干细胞移植预处理与移植后巩固治疗

🎓Key Contributions 主要贡献

APEX Trial — Definitive Phase III Validation of Bortezomib in Relapsed Myeloma

Led the APEX phase III trial (NEJM 2005; n=669) randomizing patients with relapsed myeloma to bortezomib versus high-dose dexamethasone, demonstrating significantly superior overall survival, time to progression, and response rates with bortezomib. APEX led to full FDA approval of bortezomib for relapsed myeloma in 2005 and established the proteasome inhibitor as a cornerstone of myeloma therapy.

Pomalidomide Clinical Development — Bridging IMiD Resistance

Directed early-phase and phase IIIb clinical development of pomalidomide, the third-generation IMiD, demonstrating activity in patients double-refractory to lenalidomide and bortezomib — a previously unmet need. His STRATUS trial data contributed directly to FDA approval of pomalidomide + low-dose dexamethasone for relapsed/refractory myeloma after ≥2 prior therapies.

VRd and Combination Regimen Optimization

Has been central to defining the VRd (bortezomib, lenalidomide, dexamethasone) triplet regimen through clinical investigation at Dana-Farber, including correlative studies identifying biomarkers of response and resistance, and subsequently contributed to the SWOG S0777 trial comparing VRd to Rd that established VRd as the US standard frontline regimen.

Carfilzomib and Next-Generation Proteasome Inhibitor Trials

Participated in multiple carfilzomib phase I/II/III studies (including ASPIRE and ENDEAVOR) and ixazomib development programs, contributing to the approval of both agents and the expansion of the proteasome inhibitor toolkit available to myeloma patients at different lines of therapy.

Representative Works 代表性著作

[1]

Bortezomib or High-Dose Dexamethasone for Relapsed Multiple Myeloma (APEX)

New England Journal of Medicine (2005)

Phase III APEX trial demonstrating survival benefit of bortezomib over dexamethasone in relapsed myeloma, leading to full FDA approval and establishing proteasome inhibition as a standard treatment backbone.

[2]

Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma

Blood (2014)

Pivotal phase II study of pomalidomide in double-refractory myeloma, establishing clinically meaningful activity and supporting the FDA approval of pomalidomide for this indication.

[3]

Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (PANORAMA 1)

The Lancet Oncology (2014)

Phase III PANORAMA 1 trial demonstrating PFS benefit of panobinostat (HDAC inhibitor) added to bortezomib/dexamethasone, leading to FDA approval of panobinostat for relapsed/refractory myeloma.

[4]

A phase 1/2 study of lenalidomide, bortezomib, and dexamethasone in patients with relapsed or relapsed-and-refractory multiple myeloma

Blood (2014)

Established the VRd triplet's efficacy and tolerability profile in relapsed myeloma, providing foundational data for subsequent phase III comparisons.

🏆Awards & Recognition 奖项与荣誉

🏆ASH Outstanding Abstract Achievement Award
🏆International Myeloma Foundation Brian D. Novis Research Grant (Scientific Committee)
🏆MMRF Translational Research Grant Reviewer
🏆Dana-Farber Cancer Institute Clinical Investigator Award
🏆Harvard Medical School Dean's Award for Excellence in Teaching

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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