Efficacy and Tolerability of High- versus Low-dose Lenalidomide Maintenance Therapy of Multiple Myeloma after Autologous Blood Stem Cell Transplantation.

PURPOSE: For multiple myeloma, high-dose chemotherapy and autologous blood stem-cell transplantation (ASCT) followed by lenalidomide maintenance (LenMT) at 10-15 mg/day is considered standard of care. However, dose reductions due to side effects are common and median LenMT doses achieved over time may remain lower. Dose response during LenMT has never been investigated. PATIENTS AND METHODS: In a multicenter, randomized, open-label trial, patients with multiple myeloma after ASCT and high-dose lenalidomide consolidation therapy (CT) at 25 mg/day were randomized to receive LenMT at either 25 or 5 mg/day. Primary endpoint was progression-free survival (PFS). RESULTS: Ninety-four patients (median age, 58 years) were randomized to either arm, with 22% having International Staging System (ISS) stage 3 and 22% being in complete remission (CR). After median follow-up of 46.7 months, median doses of 14.5 and 5 mg/day were achieved in the two arms; 53% of dose reductions occurring during CT. In the high- and the low-dose arm, median PFS was 44.8 and 33.0 months (HR, 0.65; 95% CI, 0.44-0.97; P = 0.032), 36% and 23% of patients had stringent CR as best response (P = 0.08), and 4-year OS was 79% and 67% (P = 0.16), respectively. Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose adjustments. SPM incidence and quality-of-life (QoL) scores in both arms were similar. CONCLUSIONS: LenMT dose correlated with efficacy and toxicity. High rates of dose reductions during CT argue against a high starting dose. However, continuous up- and down-titration for each patient to the current maximum tolerated dose is prudent.

Acceptance and effectiveness for learning of a simulation manikin for suprapubic aspiration in toddlers constructed with simple means.

BACKGROUND: Skills trainings are increasing in popularity in undergraduate medical education enhancing clinical competencies and motivation for clinical practice. A suprapubic aspiration (SPA) is the gold standard to obtain urine from toddlers and young infants with fever and unclear focus to prove an urinary tract infection. METHODS: In a blended-learning scenario with virtual patients and skills lab training students were trained for a SPA. Currently, no toddler simulation manikin for SPA is available on the market so we constructed one with simple means. Students' acceptance and their view on relevant aspects of the manikin for learning effectiveness were assessed. RESULTS: With an expenditure regarding work of 3½ h and material costs of 188.12 Euro we were able to construct a paediatric manikin for suprapubic bladder punction using a cheap basic life support manikin. N = 56 students rated their learning success with the manikin as high (77.2 ± 21.6; mean and standard deviation; visual analogue scales from 100 = totally agree to 0 = don't agree at all). The model was rated as useful for training (84.2 ± 17.2) and realistic (62.1 ± 23.5). Important factors for students' learning success were (in descending order) that "urine" could be aspirated (81.4 ± 19.5), the feel of the needle inserted in the manikin (71.5 ± 23.2), and--notably less important--the outer appearance in general (40.3 ± 24.6). CONCLUSIONS: We present a construction of a paediatric manikin for suprapubic aspiration with simple means for a realistic learning scenario with high learning success.