Alegre, A. (A.)
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- Pegylated liposomal doxorubicin, melphalan and prednisone therapy for elderly patients with multiple myeloma(Wiley-Blackwell, 2006) Alegre, A. (A.); García-Sanz, R. (Ramón); Hernandez, J.M. (J. M.); Mateos, M.V. (María Victoria); Barez, A. (A.); Garcia-Laraña, J. (J.); Prosper-Cardoso, F. (Felipe); Sureda-Balari, A. M. (Anna Maria); San-Miguel, J.F. (Jesús F.)Melphalan&Prednisone (MP) is considered as the standard therapy for Multiple Myeloma (MM) patients not eligible for high-dose therapy. Here, we report the results of a phase I–II study to evaluate the feasibility and efficacy of the association of PLDto the conventionalMP regimen during the first six cycles of the front-line therapy for untreatedMMpatients older than 70. Thirty patients were included in the study with a median age of 77 years (71–84) and a M/F ratio of 17/13. The phase I of the study demonstrated that the maximum tolerable dose of PLD in this setting was 30mg/m2, so itwas the final dose evaluated in the study. Twenty-nine patients were valuable for response, which was: complete in 4 (14%) partial in 15 (52%) minor/ no changes in 7 (24%) and progressive in 3 (10%). The median progression free survival (PFS) was 24 months. The median overall survival (OS) has not been reached yet, with a 3-year probability for OS and PFS of 52 and 37%, respectively. Haematological toxicity was frequent but usually weak/moderate (grades 1&2 of theWHOscale) and itwas resolved only with dose delays. Infection was a relatively frequent event (30%of patients), but only in 4 cases it was of grade 3. No cases of palmar-plantar erythrodysesthesia were observed. In conclusion, pegylated liposomal doxorubicin can be safely added to the other chemotherapeutic drugs in the treatment of elderly MM patients, which can be very useful for patients in whomnovel agents are not tolerated or inefficient.
- Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: updated time-to-events results and prognostic factors for time to progression(Fondazione Ferrata Storti, 2008) Alegre, A. (A.); Mateo, G. (Gemma); Bladé, J. (Joan); García-Sanz, R. (Ramón); Hernandez, J.M. (J. M.); Mateos, M.V. (María Victoria); Arriba, F. (Felipe) de; Esseltine, D.L. (D. L.); Hernandez, M.T. (Miguel Teodoro); Carrera, D. (D,); Garcia-Sanchez, P. (P.); Palomera, L. (Luis); Terol, M.J. (María José); Velde, H. (Helgi) van de; Lahuerta, J.J. (Juan José); Gutierrez, N.C. (Norma C.); Fuertes, M. (M.); Ribas, P. (Paz); Garcia-Laraña, J. (J.); Oriol, A. (Albert); Rubia, J. (Javier) de la; Prosper-Cardoso, F. (Felipe); Sureda-Balari, A. M. (Anna Maria); Bargay, J. (Joan); San-Miguel, J.F. (Jesús F.)New treatment options offering enhanced activity in elderly, newly diagnosed patients with multiple myeloma are required. One strategy is to combine melphalan and prednisone with novel agents. We previously reported an 89% response rate, including 32% complete responses and 11% near complete responses, in our phase 1/2 study of bortezomib plus melphalan and prednisone (VMP) in 60 newly diagnosed multiple myeloma patients with a median age of 75 years. Here, we report updated time-to-events data and the impact of poor prognosis factors on outcome.
- Results of an early access treatment protocol of daratumumab monotherapy in spanish patients with relapsed or refractory multiple myeloma(Wolters Kluwer Health, 2020) Blanchard, M.J. (María Jesús); Alegre, A. (A.); Bargay-Lleonart, J. (Joan); Casado-Montero, L.F. (Luis Felipe); Peñarrubia, M.J. (María Jesús); Gaudig, M. (Maren); Potamianou, A. (Anna); Hevia, H. (Henar); Mateos, M.V. (María Victoria); Milionis, I. (Iordanis); Couturier, C. (Catherine); Palomera, L. (Luis); Rodriguez-Otero, P. (Paula); Insunza, A. (Andrés); Ríos-Tamayo, R. (Rafael); González, M.S. (Marta Sonia); Suárez, A. (Alexia); Encinas-Rodríguez, C. (Cristina); Rubia, J. (Javier) de la; Sureda-Balari, A. (Anna); Pei, H. (Huiling)Daratumumab is a human CD38-targeted monoclonal antibody approved as monotherapy for heavily pretreated relapsed and refractory multiple myeloma. We report findings for the Spanish cohort of an open-label treatment protocol that provided early access to daratumumab monotherapy and collected safety and patient-reported outcomes data for patients with relapsed or refractory multiple myeloma. At 15 centers across Spain, intravenous daratumumab (16mg/kg) was administered to 73 patients who had ≥3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or who were double refractory to both. The median duration of daratumumab treatment was 3.3 (range: 0.03–13.17) months, with a median number of 12 (range: 1–25) infusions. Grade 3/4 treatment-emergent adverse events were reported in 74% of patients and included lymphopenia (28.8%), thrombocytopenia (27.4%), neutropenia (21.9%), leukopenia (19.2%), and anemia (15.1%). Common (>5%) serious treatmentemergent adverse events included respiratory tract infection (9.6%), general physical health deterioration (6.8%), and back pain (5.5%). Infusion-related reactions occurred in 45% of patients. The median change from baseline in all domains of the EQ-5D-5L and EORTC QLQ-C30 was mostly 0. A total of 18 (24.7%) patients achieved a partial response or better, with 10 (13.7%) patients achieving a very good partial response or better. Median progression-free survival was 3.98 months. The results of this early access treatment protocol are consistent with previously reported trials of daratumumab monotherapy and confirm its safety and antitumoral efficacy in Spanish patients with heavily treated relapsed or refractory multiple myeloma.
- Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study(American Society of Hematology, 2006) Alegre, A. (A.); Mateo, G. (Gemma); Bladé, J. (Joan); García-Sanz, R. (Ramón); Hernandez, J.M. (J. M.); Mateos, M.V. (María Victoria); Arriba, F. (Felipe) de; Esseltine, D.L. (D. L.); Hernandez, M.T. (Miguel Teodoro); Carrera, D. (D,); Palomera, L. (Luis); Terol, M.J. (María José); Velde, H. (Helgi) van de; Lahuerta, J.J. (Juan José); Gutierrez, N.C. (Norma C.); Fuertes, M. (M.); Ribas, P. (Paz); Garcia-Laraña, J. (J.); Oriol, A. (Albert); Rubia, J. (Javier) de la; Diaz-Mediavilla, J. (J.); Prosper-Cardoso, F. (Felipe); Sureda-Balari, A. M. (Anna Maria); Bargay, J. (Joan); San-Miguel, J.F. (Jesús F.)Standard first-line treatment for elderly multiple myeloma (MM) patients ineligible for stem cell transplantation is melphalan plus prednisone (MP). However, complete responses (CRs) are rare. Bortezomib is active in patients with relapsed MM, including elderly patients. This phase 1/2 trial in 60 untreated MM patients aged at least 65 years (half older than 75 years) was designed to determine dosing, safety, and efficacy of bortezomib plus MP(VMP). VMP response rate was 89%, including 32% immunofixation-negative CRs, of whom half of the IF– CR patients analyzed achieved immunophenotypic remission (no detectable plasma cells at 10 4 to 10 5 sensitivity). VMP appeared to overcome the poor prognosis conferred by retinoblastoma gene deletion and IgH translocations. Results compare favorably with our historical control data for MP—notably, response rate (89% versus 42%), event-free survival at 16 months (83% versus 51%), and survival at 16 months (90% versus 62%). Side effects were predictable and manageable; principal toxicities were hematologic, gastrointestinal, and peripheral neuropathy and were more evident during early cycles and in patients aged 75 years or more. In conclusion, in elderly patients ineligible for transplantation, the combination of bortezomib plus MP appears significantly superior to MP, producing very high CR rates, including immunophenotypic CRs, even in patients with poor prognostic features.
- Utilización de bisfosfonatos en pacientes con mieloma múltiple: recomendaciones del comité de expertos del Grupo Español de Mieloma del Programa Español de Tratamientos en Hematología(Elsevier Doyma, 2009) Cappelli, F. (Federica); Alegre, A. (A.); Bladé, J. (Joan); García-Sanz, R. (Ramón); Hernandez, J.M. (J. M.); Mateos, M.V. (María Victoria); Arriba, F. (Felipe) de; Rosiñol, L. (Laura); Lahuerta, J.J. (Juan José); Garcia-Laraña, J. (J.); Rubia, J. (Javier) de la; Diaz-Mediavilla, J. (J.); Prosper-Cardoso, F. (Felipe); Sureda-Balari, A. M. (Anna Maria); Bargay, J. (Joan); San-Miguel, J.F. (Jesús F.)
- Depth of Response in Multiple Myeloma: A Pooled Analysis of Three PETHEMA/GEM Clinical Trials(2017) Cedena, M.T. (María Teresa); Martínez-López, J. (Joaquín); Alegre, A. (A.); Bladé, J. (Joan); Orfao, A. (Alberto); Vidriales, M.B. (María Belén); Martin-Ramos, M.L. (Maria Luisa); Mateos, M.V. (María Victoria); Arriba, F. (Felipe) de; Hernandez, M.T. (Miguel Teodoro); Rosiñol, L. (Laura); Puig, N. (Noemí); Martin, A. (Alejandro); Cordón, L. (Lourdes); Palomera, L. (Luis); Lahuerta, J.J. (Juan José); Gutierrez, N.C. (Norma C.); Teruel, A.I. (Ana Isabel); Paiva, B. (Bruno); Oriol, A. (Albert); Rubia, J. (Javier) de la; Martínez, R. (Rafael); San-Miguel, J.F. (Jesús F.); Echeveste, M.A. (Maria Asuncion); RaquelPurpose To perform a critical analysis on the impact of depth of response in newly diagnosed multiple myeloma (MM). Patients and Methods Data were analyzed from 609 patients who were enrolled in the GEM (Grupo Español de Mieloma) 2000 and GEM2005MENOS65 studies for transplant-eligible MM and the GEM2010MAS65 clinical trial for elderly patients with MM who had minimal residual disease (MRD) assessments 9 months after study enrollment. Median follow-up of the series was 71 months. Results Achievement of complete remission (CR) in the absence of MRD negativity was not associated with prolonged progression-free survival (PFS) and overall survival (OS) compared with near-CR or partial response (median PFS, 27, 27, and 29 months, respectively; median OS, 59, 64, and 65 months, respectively). MRD-negative status was strongly associated with prolonged PFS (median, 63 months; P , .001) and OS (median not reached; P , .001) overall and in subgroups defined by prior transplantation, disease stage, and cytogenetics, with prognostic superiority of MRD negativity versus CR particularly evident in patients with high-risk cytogenetics. Accordingly, Harrell C statistics showed higher discrimination for both PFS and OS in Cox models that included MRD (as opposed to CR) for response assessment. Superior MRD-negative rates after different induction regimens anticipated prolonged PFS. Among 34 MRD-negative patients withMMand a phenotypic pattern of bone marrow involvement similar to monoclonal gammopathy of undetermined significance at diagnosis, the probability of “operational cure” was high; median PFS was 12 years, and the 10-year OS rate was 94%. Conclusion Our results demonstrate that MRD-negative status surpasses the prognostic value of CR achievement for PFS and OS across the disease spectrum, regardless of the type of treatment or patient risk group. MRD negativity should be considered as one of the most relevant end points for transplant-eligible and elderly fit patients with MM.