Poster Session I: Myeloma and other monoclonal gammopathies - Clinical
The triplet combination of Lenalidomide, Bortezomib, Dexamethasone (RVd) has shown high activity in Myeloma first line treatment in both transplant-eligible (TE) and transplant non-eligible (TNE) patients in clinical trials. In Multiple Myeloma (MM), the achievement and duration of complete response (CR) or at least very good partial response (VGPR) has been shown to be of major importance.
As this is particularly relevant in high dose therapy followed by autologous stem cell transplantation (ASCT), in Europe this regimen is not approved yet. In order to analyse the outcome of RVd-patients in Autria and Germany in a clinical routine setting with a focus on tolerability and efficacy, the ALPINA project was initiated.
Patients receiving RVd were identified using the Austrian Myeloma Registry (AMR) and local data repositories. A minimum of four completed cycles of RVd were required for TE patients, while at least 6 completed cycles of RVd were necessary for TNE patients to qualify for the analysis, making the cohorts more comparable to published trial populations (e.g. SWOG S0777, IFM 2009, GEM 2012). Besides outcome variables (e.g. best response) safety, tolerability, side effects (e.g. neuropathy) and the real-world (RW) use of regimen modifications were analysed using descriptive statistics.
Out of 141 patients, 87 patients met the inclusion criteria [TE (n = 59, 69 % cohort 1), TNE (n = 28, 31% cohort 2)]. Among the patients not included (n = 54), 17 patients discontinued therapy before reaching the specified number of cycles, while 28 patients are still on RVd treatment (but are too early to analyse).
Baseline characteristics of the ALPINA cohorts were: 52 male and 35 female MM patients, diagnosed at a median age of 57 (range 43 - 66) in cohort 1 and 69 (range 48 - 77) years in cohort 2. 59 (69 %) MM patients received an ASCT, and 28 (31 %) patients were TNE. 59 (69 %) MM patients received an ASCT, and 28 (31 %) patients were TNE. Within cohort 1, 40 (68 %) patients received a single ASCT, while 19 (32 %) patients received a tandem ASCT. The median number of applied and completed RVd cycles was 4 in cohort 1, compared to 8 cycles in cohort 2.
Bortezomib was given subcutaneously in all patients. RVd was applied uniformly 14d/21d in cohort 1 [(V 1.3 mg/m2, R 25 mg (55 pts. (93 %) and 10 mg (4 pts. (7 %)] and Dexamethasone 40 mg/week (59 pts., 100 %). RVd was used in modified schedule in 39 % of pts. in cohort 2 (e.g. RVd weekly, reduced DEX or V dosage). Dose delays were observed in 57 % of pts.
In detail cohort 1 (TE) shows a best overall response (ORR)(≥PR) of 93% with 25% PR, 27% VGPR and 41% CR. In comparison in cohort 2 (TNE) the best ORR was 89% with 32% PR, 39% VGPR and 18 % CR.
RVd is a safe and well tolerated therapy over 4 cycles pre-ASCT and at least 6 cycles in TNE patients. Despite a high dose intensity there were no therapy impeding toxicities. Deep responses (≥VGPR) were frequently achieved (68% in C1, 57% in C2). In TNE pts. dose modifications and delays were frequently observed. Only a minor fraction of patients discontinued therapy [17/141 pts. (12 %)] due to various reasons. In this RW setting RVd proved to be an effective 1st line treatment in both TE and TNE MM patients. Detailed data including relevant side effects and a comparison to clinical trials will be presented.