Cereblon pathway biomarkers and immune profiles in patients with myeloma receiving post-ASCT lenalidomide maintenance (LEOPARD).

LEOPARD was a single arm, phase II study of lenalidomide (LEN) and alternate day prednisolone maintenance in patients with newly diagnosed multiple myeloma (MM) following autologous stem cell transplantation (ASCT). Sixty patients were enrolled. Estimated median potential follow-up was 44 m, median PFS was 38.

Thalidomide and prednisolone versus prednisolone alone as consolidation therapy after autologous stem-cell transplantation in patients with newly diagnosed multiple myeloma: final analysis of the ALLG MM6 multicentre, open-label, randomised phase 3 study.

Background: We previously showed that consolidation therapy with thalidomide and prednisolone improved progression-free and overall survival in patients with multiple myeloma who had undergone autologous stem-cell transplantation. We aimed to assess whether these survival advantages were durable at 5 years.

Methods: The ALLG MM6 trial was a multicentre, open-label, randomised phase 3 trial done between Jan 13, 2002, and March 15, 2005, at 29 sites in Australia and New Zealand.

Particle release from respirators, part II: determination of the effect of tension applied in simulation of removal.

This study evaluated the potential for disposable filtering facepiece respirators (hereafter termed masks) contaminated with 1-μ m particles to release particles as a result of lateral tension applied to the mask. The lateral tension was designed to simulate the removal of a contaminated mask from a user's head. Four brands of filtering facepieces were loaded with approximately 20 million 1.

Particle release from respirators, part I: determination of the effect of particle size, drop height, and load.

In late 2001, some U.S. Postal Service workers and a few members of Congress were exposed to anthrax spores.

Design, demonstration and performance of a versatile electrospray aerosol generator for nanomaterial research and applications.

Carbon nanotubes are difficult to aerosolize in a controlled manner. We present a method for generating aerosols not only of carbon nanotubes, but also of many reference and proprietary materials including quantum dots, diesel particulate matter, urban dust, and their mixtures, using electrospraying. This method can be used as a teaching tool, or as the starting point for advanced research, or to deliver nanomaterials in animal exposure studies.

Chronic boron exposure and human semen parameters.

Boron found as borates in soil, food, and water has important industrial and medical applications. A panel reviewing NTP reproductive toxicants identified boric acid as high priority for occupational studies to determine safe versus adverse reproductive effects. To address this, we collected boron exposure/dose measures in workplace inhalable dust, dietary food/fluids, blood, semen, and urine from boron workers and two comparison worker groups (n=192) over three months and determined correlations between boron and semen parameters (total sperm count, sperm concentration, motility, morphology, DNA breakage, apoptosis and aneuploidy).

Prognostically significant cytotoxic T cell clones are stimulated after thalidomide therapy in patients with multiple myeloma.

The expanded T cell clones are associated with a prolonged survival in patients with multiple myeloma. We sought to confirm this prognostic significance in a multicenter patient cohort and investigate the effect of thalidomide on clones and T regulatory cells (T(regs)). Blood was collected from 120 patients enrolled in a Phase III trial of maintenance therapy +/- thalidomide after autologous stem cell transplantation.

Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure.

Purpose: Thalidomide is effective in the treatment of newly diagnosed and relapsed/refractory multiple myeloma (MM). However, the role of thalidomide in the post-autologous stem cell transplantation (ASCT) context remains unclear. This study assessed whether the addition of thalidomide consolidation following ASCT would improve the durability of responses achieved and overall survival.

Renal safety of zoledronic acid with thalidomide in patients with myeloma: a pharmacokinetic and safety sub-study.

Background: Cases of impaired renal function have been reported in patients who had been treated with both zoledronic acid and thalidomide for myeloma. Hence, we conducted a safety study of zoledronic acid and thalidomide in myeloma patients participating in a trial of maintenance therapy.

Methods: Twenty-four patients who were enrolled in a large randomized trial of thalidomide vs no thalidomide maintenance therapy for myeloma, in which all patients also received zoledronic acid, were recruited to a pharmacokinetic and renal safety sub-study, and followed for up to 16 months.

Measurements of ultrafine particles and other vehicular pollutants inside a mobile exposure system on Los Angeles freeways.

A mobile exposure and air pollution measurement system was developed and used for on-freeway ultrafine particle health effects studies. A nine-passenger van was modified with a high-efficiency particulate air (HEPA) filtration system that can deliver filtered or unfiltered air to an exposure chamber inside the van. State-of-the-art instruments were used to measure concentration and size distribution of fine and ultrafine particles and the concentration of carbon monoxide (CO), black carbon (BC), particle-bound polycyclic aromatic hydrocarbons (PAHs), fine particulate matter (PM2.

Biomarkers of environmental and workplace boron exposure.

The purpose of this work was to identify an accurate, noninvasive biomarker of boron exposure that could be used in worker populations. Occupational exposure to boron is of concern due to high numbers of workers exposed, animal toxicity data suggesting reproductive effects, and lack of human studies. Total daily boron exposure was determined from duplicate samples of 24-hr food and fluid intake, plus workplace personal air monitoring in boron workers and comparison groups in northern China during 2003 and 2004.

Nested case-control study of occupational physical activity and prostate cancer among workers using a job exposure matrix.

Objective: We conducted a nested case-control study of 362 cases diagnosed between 1 January 1988 and 31 December 1999, and 1,805 matched controls to examine the association between occupational physical activity and prostate-cancer incidence among workers at a nuclear and rocket engine-testing facility in Southern California.

Methods: We obtained cancer incidence data from the California Cancer Registry and seven other state cancer registries. Data from company records were used to construct a job exposure matrix (JEM) for occupational physical activity during employment.

Nested case-control study of occupational chemical exposures and prostate cancer in aerospace and radiation workers.

Background: To date, little is known about the potential contributions of occupational exposure to chemicals to the etiology of prostate cancer. Previous studies examining associations suffered from limitations including the reliance on mortality data and inadequate exposure assessment.

Methods: We conducted a nested case-control study of 362 cases and 1,805 matched controls to examine the association between occupational chemical exposures and prostate cancer incidence.

Small airways response to naturalistic cat allergen exposure in subjects with asthma.

Background: It is currently unclear whether the small airways (diameter <2 microm) contribute significantly to late asthmatic reactions to inhaled allergen.

Objectives: We sought to determine whether naturalistic exposure to cat allergen induced late responses in the small airways as measured by pulmonary function testing and high-resolution computed tomography (HRCT) of the chest performed at end-expiration.

Methods: In a group of 10 subjects with cat-induced asthma, physiologic studies (spirometry and lung volumes, including closing volume) and HRCT were performed before and 6 and 23 hours after a cat room challenge that caused a 20% or greater acute fall in FEV(1).

Estimated effects of hydrazine exposure on cancer incidence and mortality in aerospace workers.

Background: Animal studies suggest that hydrazine is a lung carcinogen, but human studies have been rare, rather small, and limited to cancer mortality.

Methods: We examined cancer mortality and incidence in a cohort of aerospace workers with varying exposure to hydrazine contained in rocket fuels-extending previous mortality follow-up from 1994 to 2001 and investigating cancer incidence for the period 1988-2000 using population-registry data. We newly estimated hydrazine effects adjusting for occupational exposures to other carcinogens assessed through a job-exposure matrix.

Estimated effects of solvents and mineral oils on cancer incidence and mortality in a cohort of aerospace workers.

Background: A retrospective cohort study of workers employed at a California aerospace company between 1950 and 1993 was conducted; it examined cancer mortality from exposures to the rocket fuel hydrazine.

Methods: In this study, we employed a job exposure matrix (JEM) to assess exposures to other known or suspected carcinogens-including trichloroethylene (TCE), polycyclic aromatic hydrocarbons (PAHs), mineral oils, and benzene-on cancer mortality (1960-2001) and incidence (1988-2000) in 6,107 male workers. We derived rate- (hazard-) ratios estimates from Cox proportional hazard models with time-dependent exposures.

Release of simulated anthrax particles from disposable respirators.

A preliminary study was undertaken to evaluate the potential for a disposable respirator that has been contaminated with anthrax spores to release spores in handling after use. The release of inert particles from disposable respirators was measured for masks dropped 3 feet onto a hard surface. Ten experimental runs were conducted for each of two N95 mask types, the Moldex 2200N95 and the 3M 8210.