Treatment Intensification With Autologous Stem Cell Transplantation and Lenalidomide Maintenance Improves Survival Outcomes of Patients With Newly Diagnosed Multiple Myeloma in Complete Response

Roberto Mina, Maria Teresa Petrucci, Paolo Corradini, Stefano Spada, Francesca Patriarca, Chiara Cerrato, Lorenzo De Paoli, Norbert Pescosta, Roberto Ria, Alessandra Malfitano, Pellegrino Musto, Luca Baldini, Tommasina Guglielmelli, Barbara Gamberi, Donato Mannina, Giulia Benevolo, Renato Zambello, Antonietta Pia Falcone, Antonio Palumbo, Arnon NaglerValeria Calafiore, Roman Hájek, Andrew Spencer, Mario Boccadoro, Sara Bringhen

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In patients with a complete response (CR), high-dose therapy with autologous stem cell transplantation (HDT-ASCT) consolidation improved progression-free survival (PFS), second PFS (PFS2), and overall survival (OS) versus R-Alk (lenalidomide, alkylator) consolidation. Also, lenalidomide maintenance therapy enhanced PFS compared with no maintenance therapy. The survival advantage with HDT-ASCT compared with R-Alk in CR patients can be attributed to the greater minimal residual disease negativity rate induced by HDT-ASCT. Background: High-dose therapy with autologous stem cell transplantation (HDT-ASCT) and maintenance treatment with novel agents are the best options for patients with newly diagnosed multiple myeloma, increasing the rate of complete response (CR) and prolonging progression-free survival (PFS) and overall survival (OS). Indeed, the achievement of a CR is a predictor of long-term survival among transplant-eligible patients. However, it is unclear whether patients reaching a CR after induction treatment could receive less intense consolidation or avoid maintenance therapy. Patients and Methods: We analyzed CR patients treated in 2 phase III trials, GIMEMA-RV-MM-PI-209 and RV-MM-EMN-441, to compare HDT-ASCT with an R-Alk (lenalidomide, alkylator) regimen as consolidation, and lenalidomide (R) maintenance with no maintenance. The primary endpoints were PFS, second PFS (PFS2), and OS from consolidation and maintenance (_m). Results: Overall, the data from 166 patients in CR were analyzed, 95 in the HDT-ASCT group and 71 in the R-Alk group. The CR patients who received HDT-ASCT had a better PFS (hazard ratio [HR], 0.55; P =.01), PFS2 (HR, 0.46; P =.02), and OS (HR, 0.42; P =.03) compared with patients randomized to R-Alk. The survival benefit with HDT-ASCT was confirmed among all the subgroups, according to age, International Staging System (ISS stage, cytogenetic profile, and receipt of maintenance therapy. CR patients who received lenalidomide maintenance had a better PFS_m (4 years: 54% vs. 19%; HR, 0.43; P =.02) compared with those who received no maintenance. However, no difference was observed in terms of PFS2_m (4 years: 72% vs. 58%; HR, 0.83; P =.67) and OS_m (4 years: 79% vs. 72%; HR, 0.82; P =.73) with maintenance therapy. Conclusion: Even in CR patients, outcomes were improved by an intensified approach with HDT-ASCT consolidation and lenalidomide-based maintenance therapy.

Original languageEnglish
Pages (from-to)533-540
Number of pages8
JournalClinical Lymphoma, Myeloma & Leukemia
Issue number8
Publication statusPublished - 1 Aug 2018


  • ASCT
  • CR
  • Lenalidomide
  • MM
  • Treatment intensification

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