{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T20:48:17Z","timestamp":1781902097349,"version":"3.54.5"},"reference-count":30,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,8,17]],"date-time":"2025-08-17T00:00:00Z","timestamp":1755388800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hematological Oncology"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Although allogeneic hematopoietic stem cell transplantation (allo\u2010HCT) is considered a potentially curative therapy for multiple myeloma, disease progression after allo\u2010HCT remains a major limitation. Post\u2010transplant maintenance therapy may help reduce the risk of relapse. Lenalidomide, an immunomodulatory agent, has demonstrated efficacy in multiple myeloma, but its use after allo\u2010HCT is limited due to concerns regarding graft\u2010versus\u2010host disease (GVHD). To evaluate the maximum tolerated dose (MTD) and dose\u2010limiting toxicity (DLT) of lenalidomide when used as maintenance therapy after allo\u2010HCT for multiple myeloma. This was a prospective, multicenter, phase I\/II clinical trial conducted from 2014 to 2019. Lenalidomide maintenance therapy was initiated 100\u2013365\u00a0days post\u2010allo\u2010HCT. Eligible patients received lenalidomide on days 1\u201321 of a 28\u2010day cycle for at least four cycles, beginning at 5\u00a0mg\/day. A standard 3\u00a0+\u00a03 dose\u2010escalation design (Fibonacci method) was used to determine DLT and MTD. The study included 10 patients; one was excluded due to early disease progression, leaving nine patients evaluable for toxicity. The phase II portion was not conducted due to expiration of the trial period. The median interval from allo\u2010HCT to initiation of lenalidomide was 244\u00a0days (range, 169\u2013330\u00a0days). At the 10\u00a0mg\/day dose level, one patient experienced moderate chronic GVHD meeting the predefined criteria for DLT. No other DLTs occurred, establishing the MTD at 10\u00a0mg\/day. No acute GVHD was observed. Two additional patients developed mild chronic GVHD, which resolved spontaneously without treatment. The 2\u2010year progression\u2010free survival (PFS) and overall survival (OS) rates from the start of maintenance therapy were 53% and 78%, respectively. Late initiation of lenalidomide maintenance therapy after allo\u2010HCT for multiple myeloma was feasible at a dose of 10\u00a0mg\/day and was associated with a low incidence of GVHD\u2010related complications. However, further studies are required to confirm treatment efficacy.<\/jats:p>","DOI":"10.1002\/hon.70129","type":"journal-article","created":{"date-parts":[[2025,8,17]],"date-time":"2025-08-17T17:13:51Z","timestamp":1755450831000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of Delayed Initiation of Lenalidomide Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma"],"prefix":"10.1002","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-9976-9787","authenticated-orcid":false,"given":"Koji","family":"Kawamura","sequence":"first","affiliation":[{"name":"Division of Hematology Jichi Medical University Saitama Medical Center  Saitama Japan"},{"name":"Division of Hematology and Clinical Laboratory Medicine Department of Multidisciplinary Internal Medicine Tottori University  Yonago 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