Lenalidomide is effective as salvage therapy in refractory or relapsed multiple myeloma: analysis of the Spanish Compassionate Use Registry in advanced patients

Abstract

We evaluated the clinical results of lenalidomide (Len) as a compassionate salvage therapy in refractory/relapsed multiple myeloma (MM) patients. A nationwide multi-centre, retrospective research study was performed to evaluate clinical data from patients with advanced MM for which compassionate use of lenalidomide was requested. The primary endpoints were the overall response rate (ORR) and the time to progression (TTP). Secondary objectives included safety and overall survival (OS) since starting of lenalidomide therapy. Data collected from the Spanish Compassionate Use Registry included 111 patients treated in 2006-2008. The median (range) number of previous treatment lines was 3 (1-8). The median duration of lenalidomide treatment while on study was of 4.9 months (1-18). Dexamethasone was given concomitantly with Len in 89% of patients. The ORR was 66% (4% of patients had stringent complete, 11% complete and 11% very good partial responses). Median TTP and OS were 13.0 and 17.4 months, respectively. The depth of response was significantly associated with a longer OS. Toxicity, mainly myelosuppression, was predictable and manageable with Len dose adjustments and cytokine support. Lenalidomide as salvage compassionate therapy in refractory/relapsed MM showed, in this series of heavily pre-treated patients, similar efficacy to that reported in pivotal clinical trials with acceptable tolerance.

Efficacy and safety of lenalidomide treatment in multiple myeloma (MM) patients—Report of the Polish Myeloma Group

“…The main AE, similarly to reports from the Greek and Spanish groups, was myelosupression, which occurred in 51.6% of patients, including grade 3 and 4 events observed in 16.7% of subjects [6,10]. In studies by Kneppers, grade 3 and 4 myelosupression occurred in 37% of patient [20].…”

“…In patients with high ␤-2 -M level, response rate was nearly 15% lower compared to patients with low ␤-2 -M levels. In Polish, German, Spanish and Italian groups, the CR/sCR responses were similar and amounted to 12.4%, 15%, 14.6%, and 11% respectively [5,6,7]. Bearing in mind that those groups comprised intensively treated patients, including subjects after ASCT (60% in case of patients with disease relapse), patients with previous thalidomide (94%), and with previous thalidomide and bortezomib use (nearly one third), the above mentioned results should be regarded as satisfactory.…”

“…In Spanish cohort, survival time was almost halved compared to our patients. However, authors highlighted that Spanish patients had very advanced disease, which usually was a qualification to symptomatic treatment [6]. Treatment response achievement resulted in a significantly longer TTP and significantly higher OS (median 36.6 and 53 months, respectively) compared to patients without treatment response (median 8 and 17 months, respectively).…”

“…In studies performed by the German group, published in 2009, and by the Spanish group, published in 2011, LEN treatment was a well tolerated and effective option for RRMM. [5,6] In the last trial performed by the Italian group in heavily pretreated patients, continuous treatment with LEN + DEX was the best predictor of longer OS. [7] In Poland, this therapy was reimbursed by the National Health Fund (NHF) from January 2008 within the frame of a non-standard chemotherapy and from January 2014 it is reimbursed within the frame of Drug Program.…”

Extramedullary plasmacytomas in the context of multiple myeloma

“…None of the pivotal The efficacy of thalidomide is not demonstrated and the data with lenalidomide are increasing. 10,11 In this paper, illustrated by three clinical cases, the role of lenalidomide in managing myeloma with extramedullary disease, is reviewed.…”