Lenalidomide plus dexamethasone for patients with relapsed or refractory multiple myeloma: Final results of a non-interventional study and comparison with the pivotal phase 3 clinical trials. (May 2018)

• Record Type: Journal Article
• Authors: Knauf, Wolfgang; Aldaoud, Ali; Losem, Christoph; Mittermueller, Johann; Neise, Michael; Niemeier, Beate; Harde, Johanna; Trarbach, Tanja; Potthoff, Karin
• Is Part Of: Leukemia research. Volume 68(2018)
• Page Start: 90
• Page End: 97
• Publication Date: 2018-05
• Subjects: AE adverse event -- ADR adverse drug reaction -- ANC absolute neutrophil count -- CI confidence interval -- CR complete remission -- CTCAE common terminology criteria for adverse events -- DEX dexamethasone -- ECOG eastern cooperative oncology group -- eCRF electronic case report form -- g/L gram/liter -- HR hazard ratio -- ISS international staging system -- LEN lenalidomide -- MM multiple myeloma -- MR minimal response -- ORR overall response rate -- OS overall survival -- Pts patients -- PFS progression-free survival -- Pla placebo -- PR partial remission -- r/r MM relapsed or refractory MM -- SAE serious adverse event -- SD standard deviation -- SmPC summary of product characteristics -- SPM second primary malignancy -- TTD time-to-treatment discontinuation -- TTP time to progression -- VGPR very good partial remission; Routine clinical practice -- Lenalidomide plus dexamethasone -- Refractory/relapsed multiple myeloma -- Safety -- Time to progression -- Thromboembolism; Leukemia -- Periodicals; Leukemia -- Periodicals; Leucémie -- Périodiques; Leukemia; Periodicals; Electronic journals; Electronic journals; 616.9941905
• DOI: 10.1016/j.leukres.2018.03.008
• Languages: English
• ISSNs: 0145-2126

Abstract

Highlights: 98 refractory/relapsed MM patients with ≥1 prior therapy were evaluable. Lenalidomide plus dexamethasone is effective in refractory/relapsed MM patients. The primary endpoint median time to progression was 12 months overall. The overall response rate was 60.2% and median overall survival was 24.3 months. Our study show similar effectiveness and safety profiles as the registration trials. Abstract: Lenalidomide (LEN) is an immunomodulatory drug with significant clinical activity against relapsed and refractory multiple myeloma (r/r MM). Based on the pivotal phase 3 trials MM-009 and MM-010, LEN in combination with dexamethasone (DEX) is approved for treatment of patients with MM who have received at least one prior therapy. LEN monotherapy is also approved in first line treatment. Here, we evaluated LEN/DEX combination therapy in a non-interventional study in patients with r/r MM in routine clinical practice. Patients received LEN/DEX as per Summary of Product Characteristics. Ninety-eight patients were treated with at least 1 cycle of LEN/DEX (median age 71 years; range, 42–88), forty-eight patients with at least 6 cycles. The Kaplan-Meier estimate for overall median time to progression was 12.0 months, 13.9 months for patients receiving second-line therapy and 10.3 months for third-line or higher-line therapy. The overall response rate was 60.2%. The median overall survival was 24.3 months. The most common adverse events were anemia (32.7%), thrombocytopenia (27.6%) and leukopenia (24.5%). Seven (7.1%) patients developed thromboembolic events despite prophylaxis. In conclusion, the combination of LEN/DEX administered to patients with r/r MM in routine clinical practice showed similar effectiveness and safety as demonstrated in the registration trials.