Summary Thalidomide is an effective agent for advanced refractory or relapsed multiple myeloma (MM), although dose‐limiting toxicity (DLT) may limit its use. This Phase I study found that a combination of low‐dose thalidomide with bendamustine and prednisolone (BPT) maintained or increased efficacy, whilst avoiding DLT in 28 patients with MM that was refractory or that had relapsed after conventional chemotherapy or high‐dose therapy with stem‐cell support. BPT comprised fixed doses of bendamustine (60 mg/m2) and prednisolone (100 mg), and escalating doses of thalidomide (50, 100, 200 mg). Treatment cycles were repeated every 28 d until the occurrence of maximum response, DLT, or disease progression. Twenty‐four patients responded after at least two cycles (four complete remission, six very good partial remission, 14 partial remission). Median progression‐free and overall survival for all patients was 11 and 19 months respectively. Only mild/moderate non‐haematological side effects were observed and no patient developed dose‐limiting haematotoxicity. Transient grade 3–4 neutropenia was reported in 12 patients, and grade 3–4 thrombocytopenia occurred in two patients. We conclude that BPT therapy was well tolerated in patients with relapsed or refractory MM, with a response rate higher than 80%. The maximum tolerated dose of thalidomide was not reached in this study.

Our investigation demonstrates that the response of tumor to neoadjuvant therapy is an independent prognostic factor in patients with rectal carcinoma.

We investigated the usefulness of peripheral blood pressure (BP) measurement in the assessment of strain in occupational physiology. Our hypothesis was that the brachial and peripheral BP reflect physiologically different events under various occupation-related demands in normotensive (NT) and hypertensive (HT) people. A group of 20 female and 20 male subjects with unmedicated mild hypertension that had been diagnosed by ambulatory blood pressure monitoring [awake time systolic/diastolic BP (BPs/BPd) 142.9 (SD 11.3)/86.4 (SD 6.2) mmHg] and 40 NT matched by age and sex [BPs/BPd 120.0 (SD 9.8)/75.6 (SD 5.9) mmHg] attended a laboratory session to undertake mental arithmetic tasks, a fingergrip test and submaximal cycle ergometry. Brachial and peripheral BP as well as heart rate were measured using a sphygmomanometer and an continuously automatic blood pressure measuring device on the finger, respectively. The peripheral BPs was higher than brachial BPs, BPd was similar for peripheral and brachial BP except during cycle ergometry. Associations between the levels of brachial and peripheral BP depended on demands and did not explain more than 42% of the common variance. The highest correlations between the two BP methods were observed during habituation, recovery and mental demands, and weak correlations during cycle ergometry. For peripheral BPs and BPd we found significant correlations in all phases of the test (r = 0.58 to 0.86, P < 0.001), also in ergometry (NT r = 0.62, P < 0.001, HT r = 0.53, P < 0.001), in contrast to the brachial BP. Peripheral BP differentiated the two BP groups (57.5%-72.5% correctly classified) which had been grouped by daily measurement of brachial BP, but brachial BP was superior in this respect with 65.0%-87.5% being correctly classified. These results supported the suggestion that the combined measurement of peripheral and brachial BP provides complementary information regarding physiological changes in NT and HT in different situations.

Thalidomide is an active single agent in advanced relapsed or refractory multiple myeloma (MM). The combination of low dose thalidomide with bendamustine and prednisolone might maintain or increase efficacy of the drug while avoiding dose limiting toxicity (DLT). Patients and Methods: The treatment consists of a fixed dose of bendamustine (60mg/qm) day 1, 8, and 15 with prednisolone (100 mg) day 1, 8, 15, and 22. In addition, thalidomide is given in three escalating doses, starting with 50 mg to a maximum of 200 mg daily. At each dose level 8 to 12 relapsed or refractory patients, half of them after conventional chemotherapy and half after high dose therapy with stem cell support, were enrolled. Cycles were repeated every 28 days for a minimum of 2 and a maximum of 10 cycles either until a maximal response was achieved, or until a DLT or a disease progression were observed. Between March 2004 and May 2006, 28 patients were enrolled: 8 in the first dose level with 50 mg thalidomide; 8 in the second dose level with 100 mg and 12 in the third dose level with 200 mg. All patients had received a minimum of 2 prior treatment regimens. Seven patients had been refractory to the last treatment. Median age was 67 years (range: 40 – 78). All patients completed 2 cycles of BPT-treatment and are therefore evaluable. Response was assessed using EBMT criteria modified to include near complete remission (nCR) and very good partial remission (VGPR). Results: Twentyfive of 28 patients responded after at least 2 cycles of chemotherapy with 3 CR, 1 nCR, 5 VGPR, 15 PR and 1 MR. Two patients had stable disease and one patient was refractory. With a median follow up of 15 months, EFS and OS at twelve months were 34 % and 92 %, respectively. The most common side effects were constipation (11 patients WHO grade 1, 8 patients WHO grade 2), polyneuropathy (15 patients WHO grade 1, 3 patients WHO grade 2) and somnolence (4 patients WHO grade 1). None of the 28 patients developed dose-limiting hematoxicity as defined by an ANC < 1,0 Gpt/l for > 7 days or an ANC < 0,5 Gpt/l for > 3 days or platelet count < 25 Gpt/l. Transient neutropenia was reported in 9 patients (WHO grade 3 and 4) but no thrombocytopenia was observed. Conclusion: BPT with a dose between 50 and 200 mg thalidomide daily is well tolerated in patients with relapsed or refractory MM.

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