Multicenter, phase II study of response-adapted lenalidomide-based therapy for transplant-ineligible patients with newly diagnosed multiple myeloma without high-risk features

Kwai Han Yoo, Dok Hyun Yoon, Hye Jin Kang, Won Sik Lee, Kihyun Kim, Jin Seok Kim, Jeong A. Kim, Sung Hyun Kim, Jae Yong Kwak, Yang Soo Kim, Chang Ki Min, Je Jung Lee, Sung Soo Yoon, Cheolwon Suh, Rachid Baz, Jae Hoon Lee

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Abstract

Lenalidomide and low-dose dexamethasone (Rd) are a standard treatment for older adults with multiple myeloma (MM). Lenalidomide monotherapy has rarely been evaluated for newly diagnosed transplant-ineligible MM patients. This multicenter phase II trial evaluated a response-adapted strategy for elderly patients with newly diagnosed MM without high-risk features. Patients were administered single-agent lenalidomide for the first 21 days of two 28-day cycles. Patients with progressive disease received Rd. The primary endpoint was progression-free survival using the uniform response assessment from the International Myeloma Working Group. Of the 34 enrolled patients, 28 were included in the efficacy analysis. The overall response rate (ORR, ≥ partial response [PR]) to single-agent lenalidomide or lenalidomide plus prednisone was 64.3%. Ten patients received Rd after disease progression, with an Rd ORR of 70%. The ORR of response-adapted lenalidomide-based therapy was 75%. After the median follow-up of 35.6 months, the median progression-free survival was 33.5 months (95% confidence interval [CI], 16.9-50.2), and the median overall survival was 51.8 months (95% CI, 22.0-81.6). The most common adverse event was neutropenia (46.7%), and 17 patients (56.7%) experienced infection including pneumonia. Response-adapted lenalidomide-based therapy was feasible in newly diagnosed, transplant-ineligible MM patients without high-risk features.

Original languageEnglish
Article number100788
JournalCurrent Problems in Cancer
Volume46
Issue number1
DOIs
Publication statusPublished - 2022 Feb

Bibliographical note

Publisher Copyright:
© 2021

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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