Dexamethasone Treatment Options in Tennessee

A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM). Read Less

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM). All eligible subjects must be previously treated with at least 3 prior regimens including lenalidomide, pomalidomide, a proteasome inhibitor and an anti-CD38 antibody and be refractory to their last line of therapy. Read Less

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer \[OC\], endometrial cancer \[EC\], non-small cell lung carcinoma \[NSCLC\], triple-negative breast cancer \[TNBC\]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \[OC and EC participants\] and Part B \[EC only\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202). Read Less

Tagraxofusp is a protein-drug conjugate consisting of a diphtheria toxin redirected to target CD123 has been approved for treatment in pediatric and adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This trial aims to examine the safety of this novel agent in pediatric patients with relapsed/refractory hematologic malignancies. The mechanism by which tagraxofusp kills cells is distinct from that of conventional chemotherapy. Tagraxofusp directly targets CD123 that is present on tumor cells, but is expressed at lower or levels or absent on normal hematopoietic stem cells. Tagraxofusp also utilizes a payload that is not cell cycle dependent, making it effective against both highly proliferative tumor cells and also quiescent tumor cells. The rationale for clinical development of tagraxofusp for pediatric patients with hematologic malignancies is based on the ubiquitous and high expression of CD123 on many of these diseases, as well as the highly potent preclinical activity and robust clinical responsiveness in adults observed to date. This trial includes two parts: a monotherapy phase and a combination chemotherapy phase. This design will provide further monotherapy safety data and confirm the FDA approved pediatric dose, as well as provide safety data when combined with chemotherapy. The goal of this study is to improve survival rates in children and young adults with relapsed hematological malignancies, determine the recommended phase 2 dose (RP2D) of tagraxofusp given alone and in combination with chemotherapy, as well as to describe the toxicities, pharmacokinetics, and pharmacodynamic properties of tagraxofusp in pediatric patients. About 54 children and young adults will participate in this study. Patients with Down syndrome will be included in part 1 of the study. Read Less

The purpose of this study is to investigate the use of the erector spinae (ESP) block in reducing the morphine milligram equivalent (MME) consumption post percutaneous nephrolithotomy. Objectives: 1. - Determine if there is a significant effect on post percutaneous nephrolithotomy MME consumption with the usage of an ESP block vs. saline control. 2. - Determine if there is a significant effect on reported pain levels with the use of an ESP block vs. saline control in post percutaneous nephrolithotomies. Read Less

This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma Read Less

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments. Read Less

Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: * To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: * Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. * Minimal residual disease (MRD) negativity rate in participants with CR. * Very good partial response or better rate, as defined by the IMWG criteria. * Overall survival (OS). * To evaluate the overall response rate (ORR) as per IMWG criteria. * To evaluate the time to progression (TTP) overall and by MRD status. * To evaluate PFS by MRD status. * To evaluate the duration of response (DOR) overall and by MRD status. * To evaluate time to first response (TT1R). * To evaluate time to best response (TTBR). * To evaluate progression-free survival on next line of therapy (PFS2). * To evaluate the sustained MRD negativity \>12 months rate. * To evaluate safety. * To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only). * To evaluate the immunogenicity of isatuximab in participants receiving isatuximab (IVRd and crossover arms). * To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status. Read Less

The study will investigate the effects of adding carfilzomib to the combination of pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with relapsed or refractory multiple myeloma. This portion of the study is complete. This study will also investigate the effects of adding daratumumab to the combination of carfilzomib, pomalidomide and dexamethasone. Read Less

Primary Objectives: * Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) * Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in Part: * To assess overall response rate (ORR) * To assess duration of response (DOR) * To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) * To assess time to diagnostic (SLiM CRAB) progression or death * To assess time to first-line treatment for multiple myeloma (MM) * To assess the potential immunogenicity of isatuximab * Impact of abnormal chromosomal subtype on participant outcome Randomized Phase 3 Part: Key Secondary Objectives: To compare between the arms * MRD negativity * Sustained MRD negativity * Second progression-free survival (PFS2) * Overall survival Other Secondary Objectives: To evaluate in both arms * CR rate * ORR * DOR * Time to diagnostic (SLiM CRAB) progression * Time to biochemical progression * Time to first-line treatment for MM * Impact of abnormal chromosomal subtype on participant outcome * Safety and tolerability * Pharmacokinetics (PK) * Potential of isatuximab immunogenicity * Clinical outcome assessments (COAs) Read Less

This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects. Read Less

Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: * To characterize the global safety profile including cumulative toxicities. * To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s). * To assess the pharmacodynamics (PD), immune response, and preliminary disease response. Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent: * Safety * Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex): * Safety * Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. * Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status. * Pharmacokinetic profile of Isatuximab. * Immunogenicity of Isatuximab. * Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response. Read Less