Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma
| Autor: | Meletios A. Dimopoulos, Cristina Gasparetto, Maeva Hellet, Pekka Anttila, Sandrine Macé, Marcelo Capra, Jian Y Yin, Matthew W Jenner, Eduardo Yanez Ruiz, Sara Bringhen, Vania Hungria, Vladimir I. Vorobyev, Rao Saleem, Craig E. Cole, Bruno Paiva, Michele Cavo, Ravi Vij |
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| Přispěvatelé: | HUS Comprehensive Cancer Center, Hematologian yksikkö, Helsinki University Hospital Area, Meletios A Dimopoulo, Sara Bringhen, Pekka M Anttila, Marcelo Capra, Michele Cavo, Craig Emmitt Cole, Cristina Gasparetto, Vania Tietsche de Moraes Hungria, Matthew W Jenner, Vladimir I. Vorobyev, Eduardo Patricio Yanez Ruiz, Jian Y Yin, Rao Saleem, Maeva Hellet, Sandrine Macé, Bruno Paiva, Ravi Vij |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Clinical Trials and Observations Immunology 3122 Cancers Phases of clinical research Antineoplastic Agents Antibodies Monoclonal Humanized Biochemistry Gastroenterology Dexamethasone law.invention 03 medical and health sciences 0302 clinical medicine Antineoplastic Agents Immunological isatuximab dexamethasone relapsed/refractory multiple myeloma Randomized controlled trial Refractory law Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Progression-free survival Adverse effect Multiple myeloma 030304 developmental biology Aged Isatuximab Aged 80 and over 0303 health sciences business.industry Antibodies Monoclonal Cell Biology Hematology Middle Aged medicine.disease Progression-Free Survival 3. Good health Thalidomide Treatment Outcome 030220 oncology & carcinogenesis Female Neoplasm Recurrence Local business Multiple Myeloma medicine.drug |
| Zdroj: | Blood |
| Popis: | This phase 2 study evaluated isatuximab as monotherapy or combined with dexamethasone in relapsed/refractory multiple myeloma (RRMM). Patients had RRMM refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) or had received ≥3 prior lines of therapy incorporating an IMiD and PI. Patients received isatuximab either as monotherapy (20 mg/kg on days 1, 8, 15, and 22 [once weekly] of cycle 1 followed by 20 mg/kg on days 1 and 15 of subsequent cycles; Isa group) or in combination with dexamethasone (40 mg/d [20 mg/d in patients aged ≥75 years] once weekly; Isa-dex group). Treated patients (N = 164) had received a median of 4 (range, 2-10) prior treatment lines. Patients received a median of 5 (1-24) and 7 (1-22) treatment cycles; at data cutoff, 13 (11.9%) of 109 and 15 (27.3%) of 55 patients remained on treatment in the Isa and Isa-dex arms, respectively. Overall response rate (primary efficacy end point) was 23.9% in the Isa arm and 43.6% in the Isa-dex arm (odds ratio, 0.405; 95% confidence interval, 0.192-0.859; P = .008). Median progression-free survival and overall survival were 4.9 and 18.9 months for Isa, and 10.2 and 17.3 months for Isa-dex. Infusion reactions (mostly grade 1/2) and hematologic abnormalities were the most common adverse events. There was a similar incidence of grade 3 or higher infections in both groups (22.0% and 21.8%). In conclusion, addition of dexamethasone to isatuximab increased response rates and survival outcomes with no detrimental effect on safety. This trial was registered at www.clinicaltrials.gov as #NCT01084252. |
| Databáze: | OpenAIRE |
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