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Lenalidomide
Source: Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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Lenalidomide is a second-generation immunomodulatory agent. Lenalidomide is associated with increased incidence of thromboembolic events, as noted with pomalidomide and thalidomide (requiring thromboprophylaxis with aspirin at least), myelosuppression (more than pomalidomide), and neuropathy (less than thalidomide, but more than pomalidomide).[58-62]
A meta-analysis of 3,254 patients from seven randomized trials showed that lenalidomide was associated with an increased risk of hematologic second primary malignancies (3.1% in patients who received lenalidomide vs. 1.4% in those who did not; HR, 3.8; 95% CI, 1.15–12.62; P = .029).[63] This risk was confined to the combination of lenalidomide and melphalan (HR, 4.86; 95% CI, 2.79–8.46; P = .0001) but was not higher for lenalidomide with either cyclophosphamide or dexamethasone.[63] A retrospective review of almost 4,000 patients with relapsed or refractory disease who received lenalidomide in 11 clinical trials suggested an increased incidence of nonmelanoma skin cancers.[64]
As a result of predominant renal clearance, lenalidomide doses need to be reduced for patients with impaired renal function (creatinine clearance, 30–50: 10 mg every day; creatinine clearance, <30: 15 mg every other day; dialysis, 15 mg on day after dialysis).[65] Uncontrolled trials have added clarithromycin (500 mg twice a day) to lenalidomide and dexamethasone, with reports of increased response rates.[66] Controlled studies are required to establish the value of this approach.
Evidence (lenalidomide):
Two prospective randomized and placebo-controlled studies of 351 and 353 patients with relapsed myeloma compared lenalidomide plus high-dose dexamethasone versus high-dose dexamethasone alone.[67,68]
Two prospective randomized and placebo-controlled studies of 351 and 353 patients with relapsed myeloma compared lenalidomide plus high-dose dexamethasone versus high-dose dexamethasone alone.[67,68]
With a median follow-up of 16 to 26 months, the median OS was 29.6 months or more (not reached in one trial) versus 20.2 months to 20.6 months in the control group (HR, 0.66; 95% CI, 0.45‒0.96; P = .03 in one study [67] and P < .001 in the other study).[68][Level of evidence A1]
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A prospective randomized study of 1,623 patients with transplant-ineligible, previously untreated myeloma compared lenalidomide and dexamethasone given until disease progression with a 72-week induction regimen with melphalan, prednisone, and thalidomide (MPT) for 72 weeks.[59]
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A prospective randomized study of 1,623 patients with transplant-ineligible, previously untreated myeloma compared lenalidomide and dexamethasone given until disease progression with a 72-week induction regimen with melphalan, prednisone, and thalidomide (MPT) for 72 weeks.[59]
With a median follow-up of 46 months, there was improved OS for the lenalidomide group, with 4-year OS rates of 52% versus 38% (HR, 0.72; 95% CI, 0.54–0.96; P = .02).[59][Level of evidence A1]
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Preserved source evidence · Not medical advice