Abstract
Lenalidomide gained Food and Drug Administration (FDA) approval for treatment of patients with relapsed or refractory multiple myeloma (MM) in combination with dexamethasone in June 2006. In April 2005, the FDA and patient advocacy groups requested an expanded access programme to both provide lenalidomide to patients likely to benefit and obtain additional safety information. Relapsed/refractory MM patients received lenalidomide 25 mg/d (days 1–21) and dexamethasone 40 mg/d (days 1–4, 9–12, and 17–20 of cycles 1–4; days 1–4 only from cycle 5 onwards), in 4-week cycles until disease progression, study drug discontinuation, or lenalidomide approval. Of the 1438 patients enrolled, ∼60% were male, median age was 64 years, and 61·7% had Durie-Salmon stage III disease. Median time on study was 15·4 weeks (range: 0·1–49·1) and median dose was 25 mg. The most common adverse events (AEs) were haematological (49%), gastrointestinal (59%), and fatigue (55%). The most common grade ≥3 AEs were haematological (45%), fatigue (10%), and pneumonia (7%). The most common serious AEs were pneumonia (8%), pyrexia (4%), and deep-vein thrombosis (3%). Primary cause of death was disease progression (10%). Safety data confirmed known AEs of lenalidomide plus dexamethasone therapy in patients with relapsed/refractory MM.
Highlights
Patients were required to have measurable levels of myeloma paraprotein in the serum (‡5Æ0 g/l) or urine (‡0Æ2 g secreted in a 24-h collection sample), and an Eastern Cooperative Oncology Group (ECOG) performance status score of £2
Thalidomide emerged as an anticancer agent after investigators demonstrated its antineoplastic activity in haematological malignancies and, in particular, for the treatment of patients with MM (Singhal et al, 1999; Rajkumar et al, 2000, 2002, 2006; Barlogie et al, 2001; Weber et al, 2003)
Lenalidomide was developed to further enhance efficacy while avoiding the teratogenicity, sedation, peripheral neuropathy, and severe constipation associated with thalidomide therapy (Richardson et al, 2002, 2006; Rajkumar et al, 2005; Dimopoulos et al, 2007; Weber et al, 2007)
Summary
The institutional review boards or ethics committees at each participating centre approved the study protocol and all patients provided written informed consent. The inclusion and exclusion criteria for the study were the same as for the pivotal phase III studies (MM-009 and MM-010) (Dimopoulos et al, 2007; Weber et al, 2007). Patients were eligible if they were aged ‡18 years, and had MM that had progressed after ‡2 cycles of anti-myeloma treatment or relapsed with progressive disease after treatment. Prior thalidomide or radiation therapy was allowed. Radiation therapy initiated prior to or at baseline was permitted concurrent to study treatment, but all other anti-myeloma medication or other therapy had to be discontinued prior to the first study dose
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