The newly reported multicenter, randomized phase 3 Myeloma XI trial recruited more patients (1917 individuals) than any previous trial; it showed that compared with postinduction therapy observation, lenalidomide maintenance significantly improved PFS — but not overall survival (OS) — for patients who were just diagnosed with multiple myeloma.1 At a median follow-up of 30.6 months, the median PFS for lenalidomide was 38.9 months, compared to 20 months for observation (hazard ratio [HR] 0.46; 95% CI: 0.41-0.53).1 Transplant-eligible (56.9 months vs 30.1 months; HR, 0.48) and transplant-ineligible patients (26 months vs 11 months; HR, 0.44) both benefited regardless of cytogenetic risk status.1 (The original protocol dose in the Myeloma XI trial was 25 mg, which was reduced to 10 mg as part of a protocol modification.2)

“The manageable safety profile of this drug and the encouraging results in subgroup analyses of patients across all cytogenetic risk groups support further investigation of maintenance lenalidomide in this setting,” Dr Nooka told Cancer Therapy Advisor. “The findings add evidence to the benefits of maintenance approaches and highlight the importance of continued therapy with lenalidomide maintenance until progression.”

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Despite encouraging data for induction therapies like RVd, there appears to be a continuing benefit for ASCT consolidation plus lenalidomide maintenance after successful induction therapy. “Patients on lenalidomide maintenance therapy had an improved PFS despite increased risk of secondary primary malignancies,” Dr Nooka noted.

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Meanwhile, a 2014 meta-analysis concluded that patients treated with lenalidomide for newly diagnosed multiple myeloma face an increased risk of developing secondary hematologic and solid cancers, associated with the addition of oral melphalan to lenalidomide therapy.5


  1. Jackson HG, Davies FE, Pawlyn C, et al. Lenalidomide maintenance versus observation for patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2019;20(1):57-73.
  2. Mateos M-V, Gonzalez de la Calle V. Lenalidomide as maintenance for every newly diagnosed patient with multiple myeloma. Lancet Oncol. 2019;20(1):5-6.
  3. Benboubker L, Dimopoulos MA, Dispenzieri A, et al. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. New Engl J Med. 2014;371(10):906-917.
  4. Durie BG, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone win patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG-S07777): a randomised, open-label, phase 3 trial. Lancet. 2017;389(10068):519-527.
  5. Palumbo A, Bringhe S, Kumar SK, et al. Second primary malignancies with lenalidomide therapy for newly diagnosed myeloma: a meta-analysis of individual patient data. Lancet Oncol. 2014;15(3):333-342.