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1696 Diseases |  |
95004 News |  |
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- | Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: De novo collapsing glomerulopathy after kidney transplantation: Description of two cases. (Pubmed Central) - Apr 28, 2023
These two cases of de novo post-transplant CG were supposed to be mainly caused by the synergic effect of metabolic factors and CNI nephrotoxicity. Identifying the etiological factors potentially responsible for de novo CG development is essential for an early therapeutic intervention and the hope of better graft and overall survival.
- | hydrocortisone / Generic mfg.
Journal: Characterising approaches to steroid therapy in paediatric multisystem inflammatory syndrome temporally associated with SARS-CoV-2. (Pubmed Central) - Apr 28, 2023
Identifying the etiological factors potentially responsible for de novo CG development is essential for an early therapeutic intervention and the hope of better graft and overall survival. Prolonged, high-dose steroid therapy is often used in the management of severe PIMS-TS with the potential for HPA axis suppression and should be withdrawn carefully.
- || dexamethasone / Generic mfg.
Review, Journal: A novel homozygous CYP17A1 mutation causes partial 17 ?-hydroxylase/17,20-lyase deficiency in 46,XX: a case report and literature review. (Pubmed Central) - Apr 28, 2023
Based on our literature review, the absence of primary amenorrhoea, hypertension or hypokalaemia cannot rule out suspicion for 17-OHD in 46,XX individuals. However, an elevation in serum progesterone levels is a highly sensitive indicator for diagnosing 17-OHD.
- | dexamethasone / Generic mfg.
Journal: Design and Evaluation of Dissolvable Microneedles for Treating Atopic Dermatitis. (Pubmed Central) - Apr 28, 2023
Significant clinical improvements, including in the dermatitis score, spleen weights, and clinical scores, were observed in an AD in vivo model using BALB/c nude mice. Taken together, our results support the hypothesis that microneedle devices loaded with dexamethasone have great potential as a treatment for AD and possibly for other skin conditions as well.
- | methylprednisolone oral / Generic mfg.
Journal: Usefulness of Oral Fluid for Measurement of Methylone and Its Metabolites: Correlation with Plasma Drug Concentrations and the Effect of Oral Fluid pH. (Pubmed Central) - Apr 28, 2023
Oral fluid pH was demonstrated to be affected by methylone administration. Oral fluid is a valid alternative to plasma for methylone determination for clinical and toxicological studies, allowing for a simple, easy and non-invasive sample collection.
- | triamcinolone acetonide / Generic mfg.
Preclinical, Journal: Cationic Nano-Lipidic Carrier Mediated Ocular Delivery of Triamcinolone Acetonide: A Preclinical Investigation in the Management of Uveitis. (Pubmed Central) - Apr 28, 2023
Oral fluid is a valid alternative to plasma for methylone determination for clinical and toxicological studies, allowing for a simple, easy and non-invasive sample collection. The total cell count was also found to be significantly low for cTA-NLC (8.73
- | methylprednisolone sodium succinate / Generic mfg.
Retrospective data, Journal: Prolongation of Pregnancy in Patients with HELLP Syndrome Using Methylprednisolone: A Retrospective Multicentric Analysis. (Pubmed Central) - Apr 28, 2023
The total cell count was also found to be significantly low for cTA-NLC (8.73 In a selected collective of patients with HELLP syndrome, prolongation of pregnancy using MP treatment improved maternal and neonatal outcomes.
- | Trial primary completion date: Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone (KRd vs. VRd) in Patients With Newly Diagnosed Multiple Myeloma (COBRA) (clinicaltrials.gov) - Apr 28, 2023
P3, N=250, Recruiting, Sponsor: University of Chicago
In a selected collective of patients with HELLP syndrome, prolongation of pregnancy using MP treatment improved maternal and neonatal outcomes. Trial primary completion date: Dec 2022 --> Dec 2024
- | Empliciti (elotuzumab) / AbbVie, BMS
Trial primary completion date: Elo-KRd: Study of Initial Treatment With Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in Multiple Myeloma (clinicaltrials.gov) - Apr 28, 2023
P2, N=47, Active, not recruiting, Sponsor: University of Chicago
Trial primary completion date: Dec 2022 --> Dec 2024 Trial primary completion date: Mar 2023 --> Mar 2025
- | Ninlaro (ixazomib) / Takeda
Trial primary completion date, Post-transplantation: Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant (clinicaltrials.gov) - Apr 28, 2023
P2, N=42, Active, not recruiting, Sponsor: University of Chicago
Trial primary completion date: Mar 2023 --> Mar 2025 Trial primary completion date: Mar 2023 --> Mar 2024
- | carfilzomib / Generic mfg., pomalidomide / Generic mfg.
Trial primary completion date: Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Apr 28, 2023
P1b/2, N=101, Recruiting, Sponsor: University of Chicago
Trial primary completion date: Mar 2023 --> Mar 2024 Trial primary completion date: Nov 2022 --> Nov 2024
- | Xtandi (enzalutamide capsule) / Pfizer, Astellas, relacorilant (CORT125134) / Corcept Therap
Trial initiation date: IRB22-1318: A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer (clinicaltrials.gov) - Apr 28, 2023
P2, N=90, Not yet recruiting, Sponsor: University of Chicago
Trial primary completion date: Nov 2022 --> Nov 2024 Initiation date: Apr 2023 --> Apr 2025
- || Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Theravance Biopharma
Trial completion date, Trial primary completion date: A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Apr 28, 2023
P4, N=252, Not yet recruiting, Sponsor: GlaxoSmithKline
Initiation date: Apr 2023 --> Apr 2025 Trial completion date: Jan 2024 --> Apr 2024 | Trial primary completion date: Jan 2024 --> Apr 2024
- || Darzalex (daratumumab) / J&J
Trial completion date, Trial primary completion date: Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma (clinicaltrials.gov) - Apr 28, 2023
P2, N=75, Recruiting, Sponsor: University of Chicago
Trial completion date: Jan 2024 --> Apr 2024 | Trial primary completion date: Jan 2024 --> Apr 2024 Trial completion date: Jan 2023 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2025
- ||| Blenrep (belantamab mafodotin-blmf) / GSK
Enrollment change, Combination therapy: IRB22-1781: Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma (clinicaltrials.gov) - Apr 28, 2023
P2, N=83, Not yet recruiting, Sponsor: University of Chicago
Trial completion date: Jan 2023 --> Jun 2025 | Trial primary completion date: Jun 2022 --> Jun 2025 N=55 --> 83
- | prednisone / Generic mfg., cyclosporin A microemulsion / Generic mfg., hydrocortisone / Generic mfg.
Enrollment change: Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP) (clinicaltrials.gov) - Apr 28, 2023
P3, N=26, Completed, Sponsor: Ohio State University
N=55 --> 83 N=16 --> 26
- ||| 3) And then the multitude of treatment options: steroids, MMF, cyclophosphamide, rituximab, budesonide, sparsentan, RAASi, SGLT2i, hydroxychloroquine, fish oil. (Twitter) - Apr 28, 2023
- || hydrocortisone / Generic mfg.
>...intravenous vitamin C (1.5 gm q 6 hourly for 4 days or until ICU discharge), hydrocortisone (50 mg q 6 hourly for 7 days or until ICU discharge followed by a taper over 3 days) as well as intravenous thiamine (200 mg q 12 hourly for 4 days or until ICU discharge). (Twitter) - Apr 27, 2023
- |||| hydrocortisone / Generic mfg.
Retrospective data: Dr Paul Marik 2016 paper: https://t.co/mp2LqZ725O Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study (Twitter) - Apr 27, 2023
- ||| hydrocortisone / Generic mfg.
Clinical: https://t.co/zp8muRwTwn). HAT therapy was first used in May 2017; this protocol consists of i.v. ascorbic acid (30 mg/kg/dose every 6 h for 4 d; maximum 1,500 mg/dose), i.v. hydrocortisone (50 mg/m2/d divided every 6 h), and i.v. thiamine (4 mg/kg/d for 4 d; maximum 200 mg/dose) (Twitter) - Apr 27, 2023
- ||| hydrocortisone / Generic mfg.
@drpaulmarik1 famous HAT protocol for sepsis in the ICU setting uses Thiamine 200mg-400mg intravenous HAT = (Hydrocortisone - Ascorbic Acid ie Vitamin C - Thiamine ie Vitamin B1) (there has been a campaign against HAT - which has all the hallmarks of the campaign against IVM) (Twitter) - Apr 27, 2023
- | dexamethasone / Generic mfg.
Journal: Pathogenesis of glucocorticoid-induced osteoporosis based on label-free mass proteomics (Pubmed Central) - Apr 27, 2023
Protein NPM1, APMAP, COX6A1 and ACP5 showed a close relationship with pathogenesis of GIOP, which could serve as potential biomarkers of GIOP. AMPK signaling pathway played an important role in the occurrence and development of GIOP, which could be regarded as potential signaling pathway to treatment GIOP.
- | Tarpeyo (budesonide) / Calliditas, Stada
Journal: Budesonide delayed-release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy. (Pubmed Central) - Apr 27, 2023
A nearly complete prevention of deterioration of renal function has been observed at 12 months in patients at greatest risk of rapid disease progression. Long-term data from Part B of the Phase 3 study will provide 24-month data, furthering understanding of the durability of the 9-month treatment course.
- || dexamethasone / Generic mfg.
Clinical, Journal: The Effect of Using Dexamethasone Tablets Vaginally for Improving Cervical Bishop Score in Nulliparous Pregnant Women: A Randomized Clinical Trial. (Pubmed Central) - Apr 27, 2023
P3
2023; 84:XXX-XXX). ClinicalTrials.gov identifier: NCT05070468.
- | carboplatin / Generic mfg., olanzapine / Generic mfg., paclitaxel / Generic mfg.
Trial completion date, Trial primary completion date: Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients (clinicaltrials.gov) - Apr 27, 2023
P3, N=170, Recruiting, Sponsor: University of Michigan Rogel Cancer Center
ClinicalTrials.gov identifier: NCT05070468. Trial completion date: Mar 2023 --> Aug 2023 | Trial primary completion date: Mar 2023 --> Aug 2023
- ||| Trial completion date: Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance (clinicaltrials.gov) - Apr 27, 2023
P3, N=406, Active, not recruiting, Sponsor: Wuerzburg University Hospital
Trial completion date: Mar 2023 --> Aug 2023 | Trial primary completion date: Mar 2023 --> Aug 2023 Trial completion date: Dec 2022 --> Dec 2023
- | Avastin (bevacizumab) / Roche
Trial completion date, Trial primary completion date: Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With Chemotherapy With/Without Bevacizumab for Hepatic Metastases From Colorectal Cancer (clinicaltrials.gov) - Apr 27, 2023
P2, N=73, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Dec 2022 --> Dec 2023 Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
- ||| Sarclisa (isatuximab-irfc) / Sanofi
Enrollment change, Trial primary completion date, Combination therapy: ISAKIDS: Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (clinicaltrials.gov) - Apr 27, 2023
P2, N=67, Active, not recruiting, Sponsor: Sanofi
Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024 N=96 --> 67 | Trial primary completion date: May 2023 --> Sep 2022
- H.P. Acthar Gel (repository corticotropin injection) / Mallinckrodt
Enrollment change: A Trial of Neuroprotection With ACTH in Acute Optic Neuritis (clinicaltrials.gov) - Apr 27, 2023
P4, N=37, Terminated, Sponsor: University of Colorado, Denver
N=96 --> 67 | Trial primary completion date: May 2023 --> Sep 2022 N=100 --> 37
- Keytruda (pembrolizumab) / Merck (MSD), Imfinzi (durvalumab) / AstraZeneca
Delayed immune toxicities in patients with breast cancer receiving immune checkpoint inhibitors. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6870;
Patients who experience irAE may be more likely to develop additional irAE at either a delayed or earlier time point. Most patients with delayed irAE experienced an irAE at an early time point.
- A novel risk assessment metric for antimyeloma therapies and drug interactions. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6863;
The single drug or doublets without dexamethasone seemed to show an improved AE profile compared to those with dexamethasone used as doublets, triplets, or quadruplets. Secondary cancer risk was much higher with high dose Mel followed by R compared with other AMDR.
- Darzalex (daratumumab) / J&J, Sarclisa (isatuximab-irfc) / Sanofi
Incidence of second primary malignancies (SPMs) in patients with multiple myeloma (MM) receiving anti-CD38 monoclonal antibodies (mAbs): A systematic review and meta-analysis. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6860;
with MM exposed to daratumumab or isatuximab, particularly that of non-invasive cutaneous tumors. This association should be further investigated in real-world settings using large databases.
- plinabulin (BPI 2358) / BeyondSpring
Safety, tolerability, and quality of life (QoL) of single-agent plinabulin (Plin) for the prevention of docetaxel (Doc) chemotherapy (chemo)-induced neutropenia (CIN) in non-small cell lung cancer (NSCLC) patients (pts) from two randomized trials. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6521;
P1/2, P3
Clinical trial information: NCT02504489. >
- Rybrevant (amivantamab-vmjw) / Genmab, J&J
Prevention of amivantamab infusion related reactions with extended pre-infusion day oral steroid therapy. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6462;
P2
This approach should be confirmed in a larger study given the ease of such an intervention to make ami infusion safer. >
- plinabulin (BPI 2358) / BeyondSpring
Prognostic value of baseline immune suppressive biomarkers to select non-small cell lung cancer (NSCLC) patients (pts) likely to benefit from the plinabulin/docetaxel (Plin/Doc) combination. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6410;
P3
Baseline NLR, PLR, and LMR, at cut-off levels to avoid IS levels, could serve as prognostic markers to identify likely responders to the immune-enhancing agent Plin in combination with Doc in NSCLC. Clinical trial information: NCT02504489.
- Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Management and outcomes of advanced stage cardiac AL amyloidosis in the daratumumab era. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6262;
Patients who received DaraCyBorD followed by OHT without ASCT achieved similar outcomes to those who received CyBorD, OHT, and ASCT. The routine use of Dara may therefore negate the need for ASCT in this setting, given its favorable toxicity profile and reduced cost.
- Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
Association of venetoclax-based therapy with increased survival in multiple myeloma (MM) harboring t(11;14): A single-center experience. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6259;
The routine use of Dara may therefore negate the need for ASCT in this setting, given its favorable toxicity profile and reduced cost. However, a randomized trial comparing bortezomib and dexamethasone
- bortezomib / Generic mfg., dexamethasone / Generic mfg., lenalidomide / Generic mfg.
Three years (yrs) maintenance with bortezomib, lenalidomide, and dexamethasone (RVD) in multiple myeloma (MM): Results of Total Therapy (TT) IIIB. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6257;
P3
Use of 3 yrs of RVD as maintenance therapy in TT IIIB did not result in improvement of outcomes of high-risk MM patients (defined by GEP) when compared to 1 yr use of maintenance bortezomib and 3 yrs use of maintenance immunomodulatory drug (TT IIIA). High-risk MM remains unmet need despite the use of extended triplet-based maintenance therapy.
- bortezomib / Generic mfg., dexamethasone / Generic mfg., bendamustine / Generic mfg.
Bendamustine-bortezomib-dexamethasone in relapsed/refractory multiple myeloma. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6255;
BVD has shown significant efficacy in a particularly severe setting of patients, relapsed and refractory to all available therapeutic resources, and, in particular cases, it could be considered as a bridge to SCT, also after failure of novel agents. Clinical trial information: FEDII 2022000378.
- iberdomide (CC-220) / BMS
A phase I/II study of carfilzomib, iberdomide (CC-220), and dexamethasone (KID) in patients with newly diagnosed transplant-eligible multiple myeloma. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6250;
P1/2
In patients who completed treatment, induction cycles with KID did not interfere with stem cell mobilization. Correlative and additional clinical data are being collected and will be presented.
- Darzalex (daratumumab) / J&J, Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
A phase IIb study of selinexor in combination with carfilzomib, daratumumab, or pomalidomide in patients with multiple myeloma relapsing on current therapy. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6249;
P2b
In this population of heavily pretreated MM patients, the ORR (33%) and CBR (92%) observed are higher compared to those seen with single-agent selinexor (ORR 4% and CBR 21%) (Chen C et al, Blood 2018). Clinical trial information: NCT04661137.
- elranatamab (PF-06863135) / Pfizer, Blenrep (belantamab mafodotin) / GSK, Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
A matching-adjusted indirect treatment comparison of elranatamab in patients with triple-class exposed relapsed/refractory multiple myeloma: Comparisons with belantamab mafodotin, selinexor plus dexamethasone, and real-world physician () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6245;
P=N/A, P2,
>ORR: objective response rate; CI: confidence interval. 1 The absolute difference between the ORR in each comparison.
- Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
Effectiveness of anti-B-cell maturation antigen (BCMA)-targeting therapy after selinexor treatment. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6241;
P1b/2, P2b
In this cohort of heavily-pretreated pts with MM who received a selinexor regimen prior to NCA, overall survival was in the range of 1 year, akin to historical results seen with ADCs. The 8-week median time between administration of selinexor and NCAs suggests that selinexor, with various partner agents, did not negatively impact overall survival with subsequent NCA therapy.
- Blenrep (belantamab mafodotin) / GSK
Ocular adverse events in transplant ineligible patients with newly diagnosed multiple myeloma treated with belantamab mafodotin plus lenalidomide/dexamethasone from the phase 1/2 BelaRd study. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6238;
P1/2
A meaningful BCVA decline was observed in a minority ( < 10%) of assessments which resolved quickly (1 month). Most importantly, a minor impact on daily functioning,
- Darzalex (daratumumab) / J&J
Real-world analysis of D-RVd v. RVd at induction for newly diagnosed transplant eligible multiple myeloma patients. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6233;
D-RVd also improved PFS with significant differences between the two groups seen at 12 and 18 months. These results add to the accumulating data that the addition of daratumumab with RVd may be the new standard of care for the aforementioned patient population.
- Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
Racial differences in outcomes of patients with relapsed/refractory multiple myeloma treated with selinexor. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6230;
P2b
Although ORRs were similar, AAs had a longer PFS compared with other races after adjusting for covariates. Despite small sample size, the differences were statistically significant.
- bortezomib / Generic mfg.
Bortezomib-induced cardiotoxicity: Real-world data from a single-center. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6224;
This gives us an opportunity to bring forward some real world data. Given the higher incidence of cardiac toxicity in our study as opposed to current available data, we propose that high-risk patients with personal or family history of cardiovascular disease could benefit from closer monitoring during the course of their treatment with Velcade.
- Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
Efficacy and safety of 40 mg vs 60 mg once weekly selinexor in combination with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma (RRMM). () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6223;
P1b/2, P2b
Most TEAEs, including nausea, occurred at lower frequency in the 40 mg cohort. Although a higher 60 mg QW SEL dose may be associated with a higher ORR, mPFS correlated with longer duration of treatment and is numerically longer for pts treated with the 40 mg dose, suggesting that clinical benefit is optimized at the lower 40 mg dose.
- Tecartus (brexucabtagene autoleucel) / Gilead
Outcomes with bendamustine lymphodepletion prior to brexucabtagene autoleucel for mantle cell lymphoma. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6210;
J Clin Oncol 2023) and ZUMA-2 outcomes (93% ORR with 67% CR rate, 12 month PFS estimate 61%; M Wang et al. NEJM 2020).
- Kineret (anakinra) / SOBI
Single center experience of using Anakinra prophylactically at Day 0 to reduce CD19 CART toxicities. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6181;
We observed that prophylactically starting Anakinra at Day 0 appeared to improve CRS and ICANS toxicities in patients receiving CART. Further prospective investigations with larger population pools would be required to better understand its role in CAR T toxicity suppression.