Continuous lenalidomide treatment after bortezomib-melphalan-prednisolone therapy for newly diagnosed multiple myeloma.

Abstract

These are the results of phase II study of bortezomib-melphalan-prednisolone (VMP) induction therapy followed by lenalidomide-dexamethasone (Rd) consolidation and lenalidomide maintenance in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), overall response rates (ORRs), and safety. Eighty-three eligible patients were enrolled between October 2012 and August 2014. The median PFS was 28.0 months (95% CI 19.6-36.7) and the median OS was 55.3 months (95% CI 51.6-NA). Among the patients who received lenalidomide maintenance therapy, median PFS was significantly improved in patients who had achieved a very good partial response (VGPR) or better (41.8 vs 20.7 months, p = 0.0070). As the best response, the rates of partial response or better were 85.5% comprising stringent complete response (sCR, 21.7%), complete response (CR, 10.8%), VGPR (18.1%), and partial response (PR, 34.9%). The most frequently observed grade 3 or higher adverse events during the VMP therapy were anemia (28.9%), neutropenia (15.6%), thrombocytopenia (6.0%), and peripheral neuropathy (2.4%). The most frequently observed grade 3 or higher adverse events during the Rd therapy were anemia (3.5%), neutropenia (1.8%), and skin rush (5.3%). The most frequently observed grade 3 or higher adverse events during lenalidomide maintenance therapy were anemia (7.4%) and neutropenia (24.1%). Thus, VMP induction therapy followed by Rd consolidation and lenalidomide maintenance is considered a well-tolerated and effective regimen in transplant-ineligible NDMM. This trial is registered with UMIN-CTR with the identification number UMIN000009042.

• Authors: Tadao Ishida, Hideo Kimura, Shuji Ozaki, Koumei Kubo, Kazutaka Sunami, Naoki Takezako, Hiroyuki Fujita, Toshiaki Hayashi, Toru Kiguchi, Kazuteru Ohashi, Satoshi Yamamoto, Hiroyuki Takamatsu, Hiroshi Kosugi, Kensuke Ohta, Rika Sakai, Hiroshi Handa, Seiji Kondo, Yu Abe, Eijiro Omoto, Kinuko Mitani, Satoshi Morita, Hirokazu Murakami, Kazuyuki Shimizu
• Journal: Annals of hematology (Ann Hematol) Vol. 99 Issue 5 Pg. 1063-1072 (May 2020) ISSN: 1432-0584 [Electronic] Germany
• PMID: 32248251 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Bortezomib
• Prednisolone
• Lenalidomide
• Melphalan

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Bortezomib (administration & dosage, adverse effects)
• Disease-Free Survival
• Female
• Humans
• Lenalidomide (administration & dosage, adverse effects)
• Male
• Melphalan (administration & dosage, adverse effects)
• Middle Aged
• Multiple Myeloma (diagnosis, drug therapy, mortality)
• Prednisolone (administration & dosage, adverse effects)
• Survival Rate