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Researchers are evaluating the safety and effectiveness of combining ruxolitinib, steroids, and lenalidomide in patients with relapsed or refractory multiple myeloma (MM) who show disease progression. Multiple myeloma is a cancer of plasma cells in the bone marrow, and despite advances in treatment, it remains incurable. This phase 1, open-label, multicenter study aims to explore new therapeutic options by targeting the JAK/STAT pathway involved in MM cell growth and survival. Participants will receive oral ruxolitinib daily on days 1 through 28, lenalidomide on days 1 through 21, and methylprednisolone daily on days 1 through 28 of each treatment cycle. The combination therapy is being studied to determine the maximum tolerated dose of ruxolitinib when used with steroids and lenalidomide. The study also monitors treatment-emergent adverse events over a period of up to 54 months. Throughout the study, participants will undergo various assessments including laboratory tests to monitor blood counts, liver and kidney function, and disease markers. Researchers will evaluate safety, tolerability, and efficacy by tracking adverse events and disease progression. Participants must be able to follow the study schedule and provide informed consent. The study also involves registration in the REVLIMID REMS program for safety monitoring related to lenalidomide use.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are evaluating the safety of atezolizumab alone or combined with bevacizumab as first-line treatment in adults with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 liver cirrhosis. This Phase II, open-label study involves participants who have not received prior systemic therapy for their condition and aims to understand treatment safety in this specific population. Participants will be assigned to one of two groups: one receiving atezolizumab plus bevacizumab, and the other receiving atezolizumab alone. Atezolizumab is given as an intravenous infusion at a dose of 1200 mg on the first day of each 21-day cycle. Bevacizumab is administered by intravenous infusion at 15 mg/kg on the same schedule. The study is conducted across multiple centers and includes multiple cohorts to evaluate these treatments separately. During the study, researchers will monitor participants for adverse events from the start until up to approximately 36 months. Assessments include measuring disease status with imaging and clinical evaluations, checking blood tests for liver and kidney function, and monitoring overall health and safety. Participants will be followed closely throughout the treatment and observation periods to gather safety data and evaluate treatment tolerability.

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

Researchers are evaluating AZD3470, a novel PRMT5 inhibitor, in participants with advanced or metastatic solid tumors that have MTAP deficiency. This first-time-in-human Phase I/IIa, open-label, multi-center study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of AZD3470 alone or combined with other anticancer agents. The study uses a modular design with multiple parts to explore different dosing and combination strategies, including a Phase 2 module comparing AZD3470 plus Datopotamab deruxtecan (Dato-DXd) to Dato-DXd alone. The study includes dose escalation and expansion cohorts in Module 1, followed by a Phase 2 Module 2 to evaluate the combination treatment's efficacy and safety. AZD3470 is given as monotherapy or alongside Dato-DXd, with additional combination modules possible in the future based on emerging results. Each treatment cycle lasts 21 days, and dosing strategies are optimized throughout the study. Participants will undergo regular assessments including tumor tissue testing for MTAP deficiency, imaging scans to measure disease progression according to RECIST criteria, and monitoring for adverse events and toxicities. Safety is closely tracked from consent through 28 days after the last dose, with specific focus on dose-limiting toxicities in early cycles and progression-free survival over about two years. The study also monitors organ function, performance status, and treatment compliance to ensure participant safety and collect comprehensive data on AZD3470's use.

Researchers are evaluating a combination treatment involving venetoclax, isatuximab, and dexamethasone for patients with relapsed or refractory multiple myeloma (MM) who have the t(11;14) chromosomal translocation. This phase 2 trial focuses on patients with this specific genetic marker, which is found in about 20% of MM cases, and aims to assess the safety and effectiveness of this combination after previous treatments have failed. The study builds on prior evidence that venetoclax, an oral BCL-2 protein inhibitor, shows activity in MM patients, especially those with t(11;14), and that monoclonal antibodies like isatuximab have demonstrated clinical benefits in this disease. Participants in the study will receive venetoclax orally at 400 mg daily during 28-day cycles, along with intravenous dexamethasone 40 mg weekly and isatuximab 10 mg/kg intravenously on a specific schedule—weekly during the first cycle and twice per cycle thereafter. This regimen is designed to evaluate how these drugs work together over time to control the disease. The isatuximab dosing schedule changes after the initial cycle to maintain treatment while reducing frequency. Throughout the 54-month study period, participants will be closely monitored for treatment-emergent adverse events to evaluate safety. Researchers will also measure response rates and clinical benefits to understand how well the combination works. Assessments include laboratory tests, imaging, and clinical evaluations to track disease status and side effects. The study includes ongoing safety follow-up and aims to provide long-term data on the combination therapy's impact on relapsed or refractory MM with the t(11;14) marker.

Researchers are evaluating the effectiveness and safety of a new drug combination called Mezigdomide (CC-92480) with bortezomib and dexamethasone (MeziVd) compared to an existing combination of pomalidomide, bortezomib, and dexamethasone (PVd). This study focuses on adults with relapsed or refractory multiple myeloma (RRMM) who have previously received between one and three lines of therapy, including prior lenalidomide treatment. The trial is a Phase 3, randomized, multicenter, open-label study aiming to improve outcomes for this condition. Participants will be assigned to receive either the MeziVd or PVd treatment regimen, with specified doses of each drug given on certain days. The study involves two treatment groups: one receiving mezigdomide, bortezomib, and dexamethasone, and the other receiving pomalidomide, bortezomib, and dexamethasone. Both regimens follow precise dosing schedules as determined by the study protocol. During the study, participants will be monitored regularly for disease progression or death, with the primary outcome being progression-free survival over up to approximately five years from the date of randomization. Ongoing assessments will include evaluations of safety and effectiveness. The total participation time may vary, and researchers will closely follow participants to gather detailed information on treatment responses and adverse effects.

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are evaluating the antimyeloma activity and safety of cemsidomide combined with dexamethasone in adults with relapsed or refractory multiple myeloma. This Phase 2, open-label, single-arm, multicenter study aims to better understand the treatment's tolerability, pharmacokinetics, and pharmacodynamics in participants who have previously received multiple therapies for their condition. Participants will receive cemsidomide orally once daily for 14 days followed by 14 days off in each 28-day cycle. Alongside this, dexamethasone will be taken orally once a week on Days 1, 8, 15, and 22 of each 28-day cycle. The study does not include a comparison group and focuses on monitoring the effects of this combination treatment over time. During the study, participants will be monitored for overall response rate based on established myeloma response criteria by an independent review committee for up to approximately 43 months. Safety, tolerability, and drug behavior in the body will be closely observed. Participants will undergo regular assessments including clinical evaluations and laboratory tests to track treatment impact and manage any side effects.

Researchers are evaluating the effectiveness of subcutaneous isatuximab delivered by an on-body delivery system combined with weekly carfilzomib and dexamethasone in adults with relapsed and/or refractory multiple myeloma (RRMM) who have received 1 to 3 prior lines of therapy. This phase 2, open-label study aims to measure the overall response rate approximately 6 months after the last participant joins, focusing on participants with measurable disease and documented diagnosis of multiple myeloma. Participants receive isatuximab via a subcutaneous on-body delivery system alongside weekly intravenous carfilzomib and oral or intravenous dexamethasone. Additional medications such as montelukast, acetaminophen, diphenhydramine, and methylprednisolone may be used as premedications or to manage infusion reactions. The treatment period lasts up to 12 months, with each treatment cycle spanning 28 days, except in cases of early discontinuation. The study includes a screening period up to 28 days, followed by the treatment phase, an end-of-treatment visit about 30 days after the last dose, and a follow-up period until death or the study's final cut-off date. Participants undergo regular assessments to evaluate response to treatment and safety. Researchers monitor overall response rate, treatment adherence, and any adverse events during and after therapy, with a total participation time extending up to approximately 32 months from the last participant's entry.