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.
Leuk Res
; 68: 90-97, 2018 05.
Article
em En
| MEDLINE
| ID: mdl-29579627
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 71â¯years; range, 42-88), forty-eight patients with at least 6 cycles. The Kaplan-Meier estimate for overall median time to progression was 12.0â¯months, 13.9â¯months for patients receiving second-line therapy and 10.3â¯months for third-line or higher-line therapy. The overall response rate was 60.2%. The median overall survival was 24.3â¯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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Dexametasona
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Protocolos de Quimioterapia Combinada Antineoplásica
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Ensaios Clínicos Fase III como Assunto
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Lenalidomida
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Mieloma Múltiplo
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Leuk Res
Ano de publicação:
2018
Tipo de documento:
Article