当前位置： SCI文献检索 > BONE MARROW TRANSPLANTATION期刊下所有文献 > Phase IIa cross-over study of propylene glycol-free melphalan (LGD-353) and alkeran in multiple myeloma autologous transplantation.

Phase IIa cross-over study of propylene glycol-free melphalan (LGD-353) and alkeran in multiple myeloma autologous transplantation.

Abstract：

:Propylene Glycol-Free melphalan HCL for Injection (PGF-Mel) is a new formulation that incorporates Captisol, a specially modified cyclodextrin, to improve melphalan stability. In this phase IIa, open-label, randomized, cross-over design bioequivalence study, the pharmacokinetics of PGF-Mel were compared with the marketed formulation of melphalan, or Alkeran. Patients received half of the total dose of melphalan in the form of Alkeran and the other half in the form of PGF-Mel in an alternating manner. The pharmacokinetic measures were determined using WinNonlin 6.2 and bioequivalence was assessed using log-transformed systemic exposure parameters. Twenty-four patients, 11 females and 13 males, were enrolled between 4 February 2010 and 16 May 2011 at The University of Kansas Medical Center and The University of Kansas Cancer Center. The median age of enrolled subjects was 58 years (range: 48-65). All patients achieved myeloablation 3 days post autologous graft followed by successful neutrophil engraftment with a median of 11 days after transplant. Pharmacokinetic analysis showed that PGF-Mel was bioequivalent with Alkeran and also revealed that maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) were higher (~10%) after PGF-Mel administration. In conclusion, PGF-Mel is considered bioequivalent to Alkeran while also demonstrating a marginally higher systemic drug exposure.

journal_name

Bone Marrow Transplant

journal_title

Bone marrow transplantation

authors

Aljitawi OS,Ganguly S,Abhyankar SH,Ferree M,Marks R,Pipkin JD,McGuirk JP

doi

10.1038/bmt.2014.120

subject

Has Abstract

pub_date

2014-08-01 00:00:00

pages

1042-5

issue

8

eissn

0268-3369

issn

1476-5365

pii

bmt2014120

journal_volume

49

pub_type

杂志文章,多中心研究,随机对照试验

相关文献

BONE MARROW TRANSPLANTATION文献大全
  • Prevention of acute GVHD by in vivo use of anti-interleukin-2 receptor monoclonal antibody (33B3.1): a feasibility trial in 15 patients.

    abstract：:Results of allogeneic bone marrow transplantation (BMT) are still impaired due mainly to acute graft-versus-host disease (GVHD). Successful T cell depletion may abolish GVHD but causes increased rates of rejection and relapse. In vivo blocking of the CD25 receptor on T cells induces efficient and selective immunosuppr...

    journal_title：Bone marrow transplantation

    pub_type： 临床试验,杂志文章

    doi：

    authors： Blaise D,Olive D,Hirn M,Viens P,Lafage M,Attal M,Stoppa AM,Gabert J,Gastaut JA,Camerlo J

    更新日期：1991-08-01 00:00:00

  • Management of acute graft-versus-host disease.

    abstract：:Current graft-versus-host disease (GVHD) prophylaxis is not uniformly successful. Since the development of GVHD has a profound impact on transplant success, treatment is required. The mainstay of therapy has been glucocorticoids (steroids), along with anti-thymocyte globulin, cyclosporine, monoclonal antibodies, and a...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章,评审

    doi：

    authors： Deeg HJ,Henslee-Downey PJ

    更新日期：1990-07-01 00:00:00

  • Early infections in patients undergoing bone marrow or blood stem cell transplantation--a 7 year single centre investigation of 409 cases.

    abstract：:Infections are a major cause of morbidity and mortality in patients undergoing high-dose therapy and subsequent autologous or allogeneic haemopoietic stem cell transplantation, despite the change from topical to systemic anti-infection prophylaxis and the introduction of growth factors and new antimicrobial drugs. We ...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1701614

    authors： Krüger W,Rüssmann B,Kröger N,Salomon C,Ekopf N,Elsner HA,Kaulfers PM,Mack D,Fuchs N,Dürken M,Kabisch H,Erttmann R,Zander AR

    更新日期：1999-03-01 00:00:00

  • The number of circulating CD34+ blood cells predicts the colony-forming capacity of leukapheresis products in children.

    abstract：:In children, only a few guidelines are available for optimizing peripheral blood progenitor cell (PBPC) harvesting. We analyzed by means of flow cytometry and clonogenic assays 60 harvest products obtained from 20 children by standardized leukapheresis after treatment with chemotherapy and CSF. In addition, 27 fresh b...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：

    authors： Leibundgut K,von Rohr A,Brülhart K,Hirt A,Ischi E,Jeanneret C,Muff J,Ridolfi-Lüthy A,Wagner HP,Tobler A

    更新日期：1995-01-01 00:00:00

  • Consensus among bone marrow transplanters for diagnosis, grading and treatment of chronic graft-versus-host disease. Committee of the International Bone Marrow Transplant Registry.

    abstract：:A questionnaire comprised of a series of clinical vignettes illustrating potential difficulties in diagnosis, grading and treatment of chronic graft-versus-host disease (GVHD) was completed by 65 bone marrow transplant physicians from 51 transplant centers worldwide. The concordance index (CI) for responses to each qu...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：

    authors： Atkinson K,Horowitz MM,Gale RP,Lee MB,Rimm AA,Bortin MM

    更新日期：1989-05-01 00:00:00

  • Enumeration of bone marrow 'homing' haemopoietic stem cells from G-CSF-mobilised normal donors and influence on engraftment following allogeneic transplantation.

    abstract：:Expression of the chemokine receptor CXCR4 on human haemopoietic stem cells (HSC) may play a crucial role in localising these cells to the bone marrow. To evaluate whether CXCR4 expression is clinically relevant we have enumerated CXCR4-positive HSC used for allogeneic transplantation and sought any relationship with ...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1703289

    authors： Spencer A,Jackson J,Baulch-Brown C

    更新日期：2001-12-01 00:00:00

  • Second unrelated bone marrow transplantation without additional conditioning therapy after engraftment failure.

    abstract：:A 37-year-old female highly alloimmunized by multiple transfusions received a sex matched HLA-identical unrelated bone marrow transplant for hypoplastic MDS-RA with moderate myelofibrosis. Conditioning consisted of total body irradiation, cyclophosphamide and ATG, GVHD prophylaxis consisted of CsA, MTX and prednisolon...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1701079

    authors： Wolff D,Becker C,Kubel M,Pönisch W,Edelmann J,Friedrich T,Helbig W

    更新日期：1998-02-01 00:00:00

  • Double reinforcement with fludarabine/high-dose cytarabine enhances the impact of autologous stem cell transplantation in acute myeloid leukemia patients.

    abstract：:Reinforced chemotherapy based on a double high-dose consolidation regimen could be a different way to enhance in vivo purging prior to autologous stem cell transplantation (auto-SCT) in acute myeloid leukemia (AML). We investigated the impact on outcome of auto-SCT after two different strategies of early intensificati...

    journal_title：Bone marrow transplantation

    pub_type： 临床试验,杂志文章

    doi：10.1038/sj.bmt.1703003

    authors： Visani G,Lemoli RM,Isidori A,Piccaluga PP,Martinelli G,Malagola M,Gugliotta L,Bonini A,Bonifazi F,Motta MR,Rizzi S,Castellani S,Tura S

    更新日期：2001-04-01 00:00:00

  • Evaluation of histogenesis of B-lymphocytes in pediatric EBV-related post-transplant lymphoproliferative disorders.

    abstract：:Post-transplant lymphoproliferative disorders (PTLD) are morphologically/clinically heterogeneous. The main goal of this study was to define the histogenesis of PTLD (B-cell phenotype, EBV-related) in seven pediatric patients after allogeneic T-cell-depleted bone marrow transplantation. Immunohistochemical stains usin...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1704395

    authors： Abed N,Casper JT,Camitta BM,Margolis D,Trost B,Orentas R,Chang CC

    更新日期：2004-02-01 00:00:00

  • IL-21 is critical for GVHD in a mouse model.

    abstract：:Immunological effects of IL-21 on T, B and natural killer (NK) cells have been reported, but the role of IL-21 in GVHD remains obscure. Here, we demonstrate that morbidity and mortality of GVHD was significantly reduced after BMT with splenocytes from IL-21R(-/-) mice compared with those from wild type mice. To furthe...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/bmt.2009.223

    authors： Meguro A,Ozaki K,Oh I,Hatanaka K,Matsu H,Tatara R,Sato K,Leonard WJ,Ozawa K

    更新日期：2010-04-01 00:00:00

  • Expression of a free gamma heavy chain in serum following autologous stem cell transplantation for IgG kappa multiple myeloma.

    abstract：:A 41-year-old male with IgG kappa multiple myeloma is described. He developed a free gamma heavy chain without an accompanying light chain following high-dose chemotherapy and autologous peripheral blood stem cell transplantation. The free gamma heavy chain was detected in serum and urine specimens 2 months after tran...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1702850

    authors： Butch AW,Badros A,Desikan KR,Munshi NC

    更新日期：2001-03-01 00:00:00

  • Prognostic factors for survival after autologous transplantation: a single centre experience in 133 multiple myeloma patients.

    abstract：:Autologous stem cell transplantation (ASCT) has an established role in the treatment of symptomatic multiple myeloma (MM). Our aim was to analyse the impact of selected prognostic parameters on the survival of patients with MM after ASCT. The new International Staging System (ISS) was also evaluated. A total of 133 MM...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1704728

    authors： Krejci M,Buchler T,Hajek R,Svobodnik A,Krivanova A,Pour L,Adam Z,Mayer J,Vorlicek J

    更新日期：2005-01-01 00:00:00

  • Mesenchymal stromal cells: a novel and effective strategy for facilitating engraftment and accelerating hematopoietic recovery after transplantation?

    abstract：:MSCs are multipotent cells that can be isolated from several human tissues and expanded ex vivo for clinical use. They comprise a heterogeneous population of cells, which, through production of growth factors, cell-to-cell interactions and secretion of matrix proteins, has a role in the regulation of hematopoiesis. In...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章,评审

    doi：10.1038/bmt.2011.102

    authors： Bernardo ME,Cometa AM,Locatelli F

    更新日期：2012-03-01 00:00:00

  • Transdermal fentanyl in HSCT patients: an open trial using transdermal fentanyl for the treatment of oral mucositis pain.

    abstract：:Fentanyl is a synthetic opioid that can be delivered through a transdermal therapeutic system (TTS). The aim of this study was to assess the efficacy of fentanyl TTS in treating oral mucositis pain in 75 adult hematopoietic stem cell transplant (HSCT) patients. The analysis was based on 62 patients who developed mucos...

    journal_title：Bone marrow transplantation

    pub_type： 临床试验,杂志文章

    doi：10.1038/sj.bmt.1704515

    authors： Demarosi F,Lodi G,Soligo D,Sardella A,Volpe AD,Carrassi A,Deliliers GL

    更新日期：2004-06-01 00:00:00

  • Calcineurin inhibitor-free GVHD prophylaxis with sirolimus, mycophenolate mofetil and ATG in Allo-SCT for leukemia patients with high relapse risk: an observational cohort study.

    abstract：:Certain leukemias have a high relapse risk even after allo-SCT, and GVHD prophylaxis with calcineurin inhibitors (CNIs) may interfere with a possible GVL effect. Therefore, we replaced CYA by sirolimus in patients with high relapse risk. In contrast to CNIs, sirolimus promotes the generation of regulatory T-cells and ...

    journal_title：Bone marrow transplantation

    pub_type： 临床试验,杂志文章

    doi：10.1038/bmt.2008.377

    authors： Schleuning M,Judith D,Jedlickova Z,Stübig T,Heshmat M,Baurmann H,Schwerdtfeger R

    更新日期：2009-05-01 00:00:00

  • Unsuccessful CTL transfusion in a case of post-BMT Epstein-Barr virus-associated lymphoproliferative disorder (EBV-LPD).

    abstract：:A patient with AML (FAB M4Eo) developed EBV-LPD 1.5 months after allogeneic BMT from his one locus-mismatched mother, the diagnosis being confirmed on day +82. Attempts to eradicate the monoclonally proliferating LPD using chemotherapy (VP16/dexamethasone) followed by two doses of EBV-specific CTL and one dose of unst...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1700883

    authors： Imashuku S,Goto T,Matsumura T,Naya M,Yamori M,Hojo M,Hibi S,Todo S

    更新日期：1997-08-01 00:00:00

  • Rapid and sustained hematopoietic reconstitution by peripheral blood stem cell infusion alone following high-dose chemotherapy.

    abstract：:We utilized mobilized peripheral blood stem cells (PBSC) as sole support for hematologic reconstitution following high-dose chemotherapy in 52 patients with advanced solid tumors and lymphoma. PBSC were collected by large scale leukapheresis after mobilization with chemotherapy. Each apheresis product was analysed for...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：

    authors： Schwartzberg L,Birch R,Blanco R,Wittlin F,Muscato J,Tauer K,Hazelton B,West W

    更新日期：1993-05-01 00:00:00

  • Reduced-intensity vs myeloablative conditioning allogeneic hematopoietic SCT for patients aged over 45 years with ALL in remission: a study from the Adult ALL Working Group of the Japan Society for Hematopoietic Cell Transplantation (JSHCT).

    abstract：:In this study, outcomes for 575 adult ALL patients aged ≥45 years who underwent first allo-SCT in CR were analyzed according to the type of conditioning regimen (myeloablative conditioning (MAC) for 369 patients vs reduced-intensity conditioning (RIC) for 206 patients). Patients in the RIC group were older (median age...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章,多中心研究

    doi：10.1038/bmt.2013.68

    authors： Tanaka J,Kanamori H,Nishiwaki S,Ohashi K,Taniguchi S,Eto T,Nakamae H,Minagawa K,Miyamura K,Sakamaki H,Morishima Y,Kato K,Suzuki R,Nishimoto N,Oba K,Masauzi N

    更新日期：2013-11-01 00:00:00

  • Scintigraphic study of the major salivary glands in pediatric bone marrow transplant recipients.

    abstract：:Total body irradiation (TBI) at bone marrow transplantation (BMT) is shown to cause salivary gland dysfunction in children. The aim of the investigation was to study the function of major salivary glands in long-term surviving children following treatment with TBI, using salivary gland scintigraphy (SGS). Thirteen pat...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1702556

    authors： Bågesund M,Richter S,Agren B,Ringdén O,Dahllöf G

    更新日期：2000-10-01 00:00:00

  • Predicting PBSC harvest failure using circulating CD34 levels: developing target-based cutoff points for early intervention.

    abstract：:PBSCs are usually mobilized using G-CSF with or without chemotherapy. With the emergence of newer mobilizing agents, predicting poor mobilization may allow early intervention and prevent the costs and complications associated with remobilization. We retrospectively evaluated a cohort of 1556 patients seen between Janu...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/bmt.2010.236

    authors： Sinha S,Gastineau D,Micallef I,Hogan W,Ansell S,Buadi F,Dingli D,Dispenzieri A,Gertz M,Greiner C,Hayman S,Inwards D,Johnston P,Lacy M,Litzow M,Porrata L,Winters JL,Kumar S

    更新日期：2011-07-01 00:00:00

  • Relationship between clinical and BK virological response in patients with late hemorrhagic cystitis treated with cidofovir: a retrospective study from the European Group for Blood and Marrow Transplantation.

    abstract：:To investigate the relationship between clinical response and modification of BK viremia, we assessed retrospectively 32 cases of hemorrhagic cystitis (HC) after allogeneic hematopoietic SCT that were treated with i.v. cidofovir (CDV). They were 22 men (69%) and 10 women (31%) with a median age of 24 years, range 3-62...

    journal_title：Bone marrow transplantation

    pub_type： 临床试验,杂志文章,多中心研究

    doi：10.1038/bmt.2012.247

    authors： Cesaro S,Pillon M,Tridello G,Aljurf M,Martino R,Schroyens W,Nozzoli C,Barba P,Faraci M,Fagioli F,Cappelli B,Cordonnier C,Al-Mohareb F,Floisand Y,Greil J,Panizzolo IS,Santarone S

    更新日期：2013-06-01 00:00:00

  • Blood tacrolimus concentrations in bone marrow transplant patients undergoing plasmapheresis.

    abstract：:Microangiopathic hemolytic anemia (MAHA) is a well-described complication of stem cell transplantation. Plasmapheresis is one modality utilized as therapy for patients who develop this complication. However, plasmapheresis may alter whole blood levels of certain medications and its effect on tacrolimus in bone marrow ...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1702174

    authors： Hale GA,Reece DE,Munn RK,Kniska AB,Phillips GL

    更新日期：2000-02-01 00:00:00

  • Cognitive and adaptive behavior 1 and 3 years following bone marrow transplantation.

    abstract：:Children receiving a bone marrow transplant (BMT) are at risk for neuropsychological late effects because of potentially neurotoxic chemotherapy and total body irradiation. The goal of this study was to prospectively and longitudinally assess the intellectual and adaptive functioning of children receiving a BMT. This ...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1700699

    authors： Kramer JH,Crittenden MR,DeSantes K,Cowan MJ

    更新日期：1997-03-01 00:00:00

  • High-dose therapy with BEAC conditioning compared to BEAM conditioning prior to autologous stem cell transplantation for non-Hodgkin lymphoma: no differences in toxicity or outcome. A matched-control study of the EBMT-Lymphoma Working Party.

    abstract：:A recent shortage of melphalan has prompted the use of alternatives to BEAM (BCNU, Etoposide, Cytarabine, Melphalan) conditioning for autologous stem cell transplantion (ASCT). The BEAC (BCNU, Etoposide, Cytarabine, Cyclophosphamide) regimen has been employed as a conditioning regimen in lymphoma patients. However, th...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/s41409-018-0196-3

    authors： Robinson SP,Boumendil A,Finel H,Dreger P,Sureda A,Hermine O,Montoto S

    更新日期：2018-12-01 00:00:00

  • Cumulative chemotherapy increases mafosfamide toxicity for normal progenitor cells in AML patients: rationale for cryopreserving adapted-dose purged marrow early in first complete remission.

    abstract：:To evaluate whether conditions for adapted dose mafosfamide (mafo) purging vary with accumulating chemotherapy, we studied the sensitivity of bone marrow CFU-GM in a total of 30 patients at different stages of treatment. We determined the dose of 95% CFU-GM growth-inhibition by mafo (ID95) in 23 patients with acute my...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：

    authors： Martin H,Bruecher J,Claudé R,Hoelzer D

    更新日期：1993-11-01 00:00:00

  • Autologous peripheral blood progenitor cell transplantation for non-Hodgkin's lymphoma with extensive bone marrow necrosis.

    abstract：:A patient with malignant lymphoma, large cell type and extensive bone marrow necrosis at presentation is reported. Bone marrow necrosis persisted even after a complete remission was induced with standard chemotherapy. Because of this adverse prognostic factor, circulating stem cells were collected and reinfused follow...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1700786

    authors： Khan AM,Yamase H,Tutschka PJ,Bilgrami S

    更新日期：1997-05-01 00:00:00

  • CD34+ cell dose, conditioning regimen and prior chemotherapy: factors with significant impact on the early kinetics of donor chimerism after allogeneic hematopoietic cell transplantation.

    abstract：:The aim of this study was to define factors that significantly influence the early kinetics of donor chimerism after transplantation. In a retrospective study, the percentage of donor chimerism in peripheral blood measured with sex-chromosome-specific probes and fluorescence-in situ hybridization was analyzed in 184 r...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/sj.bmt.1704710

    authors： Mohr B,Koch R,Thiede C,Kroschinsky F,Ehninger G,Bornhäuser M

    更新日期：2004-12-01 00:00:00

  • Safety and efficacy of fresh whole blood donor lymphocyte infusion in children.

    abstract：:Donor lymphocyte infusion (DLI) is a form of cellular immunotherapy which is known to be effective in preventing relapse in leukemia by inducing graft versus leukemia (GVL) effect. In hematopoietic stem cell transplantation (HSCT) for benign hematological conditions including primary immune deficiency, mixed chimerism...

    journal_title：Bone marrow transplantation

    pub_type： 临床试验,杂志文章

    doi：10.1038/s41409-019-0580-7

    authors： Swaminathan VV,Uppuluri R,Patel S,Sivashankaran M,Ravichandran N,Ramanan KM,Ramakrishnan B,Vaidhyanathan L,Raj R

    更新日期：2019-11-01 00:00:00

  • Impact of pretransplant donor-specific anti-HLA antibodies on cord blood transplantation on behalf of the Transplant Complications Working Group of Japan Society for Hematopoietic Cell Transplantation.

    abstract：:Graft failure (GF) remains a major complication of cord blood transplantation (CBT). Although the presence of pretransplant, donor-specific anti-HLA antibodies (DSA) was reported to be associated with an increased risk of GF after CBT, data are still limited. Thus, we conducted a retrospective analysis of recipients o...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：10.1038/s41409-019-0712-0

    authors： Fuji S,Oshima K,Ohashi K,Sawa M,Saito T,Eto T,Tanaka M,Onizuka M,Nakamae H,Shiratori S,Ozawa Y,Hidaka M,Nagamura-Inoue T,Tanaka H,Fukuda T,Ichinohe T,Atsuta Y,Ogata M

    更新日期：2020-04-01 00:00:00

  • Correlation of colony-forming cells, long-term culture initiating cells and CD34+ cells in apheresis products from patients mobilized for peripheral blood progenitors with different regimens.

    abstract：:Peripheral blood progenitor cell (PBPC) populations used for transplantation were analyzed for the presence of CD34+ cells, colony-forming cells (initial CFC), and long-term culture initiating cells (LTC-IC) cultured on irradiated stroma for 5 weeks. Thirty-eight leukapheresis products were studied from 11 patients wi...

    journal_title：Bone marrow transplantation

    pub_type： 杂志文章

    doi：

    authors： Bender JG,Lum L,Unverzagt KL,Lee W,Van Epps D,George S,Coon J,Ghalie R,McLeod B,Kaizer H

    更新日期：1994-04-01 00:00:00