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"MOBILIZATION"
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Japan's economic planning and mobilization in wartime, 1930s-1940s : the competence of the state
\"Although most economists maintain a mistrust of a government's goals when it intervenes in an economy, many continue to trust its actual ability. They retain, in other words, a faith in state competence. For this faith, they adduce no evidence. Sharing little skepticism about the government's ability, they continue to expect the best of governmental intervention. To study government competence in World War II Japan offers an intriguing laboratory. In this book, Yoshiro Miwa shows that the Japanese government did not conduct requisite planning for the war by any means. It made its choices on an ad hoc basis and the war itself quickly became a dead end. That the government planned for the war incompetently casts doubts on the accounts of Japanese government leadership more generally\"-- Provided by publisher.
Book
Impact of single dose of pegfilgrastim on peripheral blood stem cell harvest in patients with multiple myeloma or malignant lymphoma
This phase 2 study evaluated the impact of pegfilgrastim, a single-dose, long-acting granulocyte colony-stimulating factor, on the steady-state mobilization of hematopoietic stem cells into peripheral blood in patients with multiple myeloma (MM) or malignant lymphoma (ML). Efficacy and safety, along with CD34-positive cell mobilization outcomes were assessed in patients with MM, who were randomly assigned to pegfilgrastim (
n
= 30) or daily filgrastim (
n
= 31), and ML (pegfilgrastim only,
n
= 13) cohorts. In the MM cohort, CD34-positive cell counts ≥ 2 × 10
6
/kg were achieved in 100% of patients in the pegfilgrastim group and 96.7% in the filgrastim group (difference: 3.3%; 80% confidence interval: −0.9–7.5%), demonstrating the non-inferiority of pegfilgrastim to filgrastim. All patients in the ML cohort achieved ≥ 2 × 10
6
/kg CD34-positive cell counts. The plerixafor administration rates in the MM cohort were 50.0% and 63.3% in the pegfilgrastim and filgrastim groups, respectively, and 91.7% in the ML cohort. There were no major differences in safety measures between the two groups. Although the sample size was small, particularly in the ML cohort, a single dose of pegfilgrastim demonstrated comparable efficacy and safety to daily doses of filgrastim, indicating its potential for clinical use while reducing patient burden.
Trial Registration: jRCT2011210029, NCT05007652.
Journal Article
Destructive Creation : American Business and the Winning of World War II
\"During World War II, the United States helped vanquish the Axis powers by converting its enormous economic capacities into military might. Producing nearly two-thirds of all the munitions used by Allied forces, American industry became what President Franklin D. Roosevelt called 'the arsenal of democracy.' Crucial in this effort were business leaders. Some of these captains of industry went to Washington to coordinate the mobilization, while others led their companies to churn out weapons. In this way, the private sector won the war--or so the story goes. Based on new research in business and military archives, Destructive Creation shows that the enormous mobilization effort relied not only on the capacities of private companies but also on massive public investment and robust government regulation. This public-private partnership involved plenty of government-business cooperation, but it also generated antagonism in the American business community that had lasting repercussions for American politics. Many business leaders, still engaged in political battles against the New Deal, regarded the wartime government as an overreaching regulator and a threatening rival. In response, they mounted an aggressive campaign that touted the achievements of for-profit firms while dismissing the value of public-sector contributions. This probusiness story about mobilization was a political success, not just during the war, but afterward, as it shaped reconversion policy and the transformation of the American military-industrial complex\"--Book jacket.
Book
GENESIS: Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma
Effective hematopoietic cell transplantation relies upon collecting adequate numbers of CD34
hematopoietic stem cells, typically from peripheral blood. A minimum of ≥2 × 10
CD34
cells/kg are necessary, while transplants of ≥5–6 × 10
CD34
cells/kg are associated with improved hematopoietic recovery. Granulocyte colony stimulating factor (G-CSF) remains the gold standard for hematopoietic stem cell mobilization. However, in randomized trials for autologous-hematopoietic cell transplantation in multiple myeloma, approximately 45% of patients remain unable to optimally mobilize with G-CSF alone despite multiple injections and apheresis days. Therefore, reducing mobilization failures remains an unmet need. The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10
CD34
cells/kg in up to two apheresis days. ClinicalTrials.gov: NCT03246529
Journal Article
On military culture : theory, practice and African armed forces
\"Military professionalism is inherently linked to military culture, which centres on the collective activities and distinctive practices of armed forces, as well as an understanding of shared goals and how they are achieved\" -- Back cover.
Book
Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial
Autologous hematopoietic stem cell transplantation (ASCT) improves survival in multiple myeloma (MM). However, many individuals are unable to collect optimal CD34
+
hematopoietic stem and progenitor cell (HSPC) numbers with granulocyte colony-stimulating factor (G-CSF) mobilization. Motixafortide is a novel cyclic-peptide CXCR4 inhibitor with extended in vivo activity. The GENESIS trial was a prospective, phase 3, double-blind, placebo-controlled, multicenter study with the objective of assessing the superiority of motixafortide + G-CSF over placebo + G-CSF to mobilize HSPCs for ASCT in MM. The primary endpoint was the proportion of patients collecting ≥6 × 10
6
CD34
+
cells kg
–1
within two apheresis procedures; the secondary endpoint was to achieve this goal in one apheresis. A total of 122 adult patients with MM undergoing ASCT were enrolled at 18 sites across five countries and randomized (2:1) to motixafortide + G-CSF or placebo + G-CSF for HSPC mobilization. Motixafortide + G-CSF enabled 92.5% to successfully meet the primary endpoint versus 26.2% with placebo + G-CSF (odds ratio (OR) 53.3, 95% confidence interval (CI) 14.12–201.33,
P
< 0.0001). Motixafortide + G-CSF also enabled 88.8% to meet the secondary endpoint versus 9.5% with placebo + G-CSF (OR 118.0, 95% CI 25.36–549.35,
P
< 0.0001). Motixafortide + G-CSF was safe and well tolerated, with the most common treatment-emergent adverse events observed being transient, grade 1/2 injection site reactions (pain, 50%; erythema, 27.5%; pruritis, 21.3%). In conclusion, motixafortide + G-CSF mobilized significantly greater CD34
+
HSPC numbers within two apheresis procedures versus placebo + G-CSF while preferentially mobilizing increased numbers of immunophenotypically and transcriptionally primitive HSPCs. Trial Registration:
ClinicalTrials.gov
, NCT03246529
The phase 3 GENESIS trial reports the superiority of the novel CXCR4 inhibitor motixafortide with G-CSF in mobilizing hematopoietic progenitor cells for autologous stem cell transplantation in multiple myeloma.
Journal Article
A phase III randomized crossover trial of plerixafor versus G-CSF for treatment of WHIM syndrome
BACKGROUNDWarts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome is a primary immunodeficiency disorder caused by heterozygous gain-of-function CXCR4 mutations. Myelokathexis is a kind of neutropenia caused by neutrophil retention in bone marrow and in WHIM syndrome is associated with lymphopenia and monocytopenia. The CXCR4 antagonist plerixafor mobilizes leukocytes to the blood; however, its safety and efficacy in WHIM syndrome are undefined.METHODSIn this investigator-initiated, single-center, quadruple-masked phase III crossover trial, we compared the total infection severity score (TISS) as the primary endpoint in an intent-to-treat manner in 19 patients with WHIM who each received 12 months treatment with plerixafor and 12 months treatment with granulocyte CSF (G-CSF, the standard of care for severe congenital neutropenia). The treatment order was randomized for each patient.RESULTSPlerixafor was nonsuperior to G-CSF for TISS (P = 0.54). In exploratory endpoints, plerixafor was noninferior to G-CSF for maintaining neutrophil counts of more than 500 cells/μL (P = 0.023) and was superior to G-CSF for maintaining lymphocyte counts above 1,000 cells/μL (P < 0.0001). Complete regression of a subset of large wart areas occurred on plerixafor in 5 of 7 patients with major wart burdens at baseline. Transient rash occurred on plerixafor, and bone pain was more common on G-CSF. There were no significant differences in drug preference or quality of life or the incidence of drug failure or serious adverse events.CONCLUSIONPlerixafor was not superior to G-CSF in patients with WHIM for TISS, the primary endpoint. Together with wart regression and hematologic improvement, the infection severity results support continued study of plerixafor as a potential treatment for WHIM syndrome.TRIAL REGISTRATIONClinicaltrials.gov NCT02231879.FUNDINGThis study was funded by the Division of Intramural Research, National Institute of Allergy and Infectious Diseases.
Journal Article