Bortezomib, liposomal doxorubicin and dexamethasone followed by thalidomide and dexamethasone is an effective treatment for patients with newly diagnosed multiple myeloma with Internatinal Staging System stage II or III, or extramedullary disease

Abstract

We evaluated sequential bortezomib, liposomal doxorubicin and dexamethasone (BDD) followed by thalidomide and dexamethasone (TD) if ≥ partial response (PR) or bortezomib and TD (BTD) if < PR in untreated patients with multiple myeloma with International Staging System stage II/III or extramedullary disease. Of the 42 patients enrolled, two-thirds had cytogenetic abnormalities including high-risk findings [del(13q) by karyotype, t(4;14), loss of p53 or gain 1q] in one-third. After the planned three cycles of BDD, the overall response rate (ORR) was 81% with 40% ≥ very good partial response (VGPR), including 26% near complete and complete responses (nCR/CR). After the additional two cycles of TD or BTD, ORR was 83% with 60% ≥ VGPR including 43% nCR/CR, indicating deeper responses following sequential therapy (p = 0.008). Two-thirds of patients who presented with significant renal impairment had improved renal function. All patients undergoing stem cell harvest had a successful collection. BDD followed by TD or BTD is effective initial therapy for this population with higher-risk myeloma and results in rapid disease control and a high response rate.

Keywords::

• Multiple myeloma
• sequential therapy
• extramedullary
• bortezomib
• renal failure

Acknowledgements

The authors gratefully acknowledge the assistance provided by Craig Moskowitz, MD and Sergio Giralt, MD during the writing of this manuscript. This study was funded by Centocor Ortho Biotech L.L.C. (Johnson & Johnson Pharmaceutical Research L.L.C.) who also provided liposomal doxorubicin. The authors thank Millennium Pharmaceuticals, Inc. for providing bortezomib. Finally, the authors acknowledge all of the patients who participated in this study and the nurses and families who took care of them.

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