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Researchers are evaluating a combination therapy of ruxolitinib, steroids, and lenalidomide in adults with relapsed or refractory multiple myeloma MM who have progressive disease despite previous treatments. MM is a cancer of plasma cells in the bone marrow with complex causes and limited curative options. This phase 1, open-label, multicenter study aims to assess the safety and effectiveness of these drugs together in patients who have failed at least two prior therapies including immunomodulatory drugs and proteasome inhibitors. Participants receive varying doses of ruxolitinib orally twice daily, lenalidomide once daily, and methylprednisolone every other day. The study includes dose escalation periods and treatment adjustments based on disease progression. Some groups start with ruxolitinib and steroids, adding lenalidomide only if the disease worsens. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will have regular evaluations including blood tests and clinical assessments to monitor safety, side effects, and treatment response. Researchers will measure outcomes such as the maximum tolerated dose, adverse events, response rates, progression-free and overall survival over a follow-up period extending up to 54 months. Participants are expected to adhere to visit schedules and study requirements throughout the trial.

Researchers are evaluating a new medication called VH4524184 for treating adults with HIV-1 who have never received treatment before. This Phase 2b study compares two doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide FTCTAF, against a standard HIV treatment combining dolutegravir and lamivudine DTG3TC. The goal is to collect long-term data on the antiviral activity of VH4524184 and to understand the best dosing for future studies. Participants are assigned to one of several groups one group receives a low dose of VH4524184 plus FTCTAF daily for 12 months, another group receives a high dose of VH4524184 plus FTCTAF daily for 12 months, and a third group takes DTG and 3TC daily for 24 months. After 12 months, those on VH4524184 may continue with a selected dose combined with FTCTAF daily until month 24. All medications are taken orally. During the study, participants attend scheduled visits for assessments including blood tests to measure HIV-1 RNA levels, CD4 T-cell counts, and drug concentrations. Researchers monitor the percentage of participants achieving viral suppression at 12 months and maintain it through 24 months. Safety is closely observed through tracking adverse events until roughly month 36. The total participation time may span up to 36 months to evaluate the long-term effects and safety of the treatments.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

Researchers are studying AZD3470, a new drug that inhibits PRMT5, in adults with advanced or metastatic solid tumors that lack the MTAP gene. This first-in-human Phase IIIa trial aims to evaluate the safety, tolerability, how the drug moves and acts in the body, and early signs of effectiveness. The study includes several parts to test AZD3470 alone or combined with other cancer drugs like Datopotamab deruxtecan Dato-DXd. New combination treatments may be added based on ongoing results. Participants will join different modules where they receive varying doses of AZD3470 alone or with Dato-DXd, or Dato-DXd alone as a control. The study starts with dose escalation and optimization phases to find the best dose. Later phases focus on evaluating AZD3470 combined with Dato-DXd versus Dato-DXd alone for efficacy and safety. Treatments are given in cycles of 21 days, and the study design allows for sequential evaluation across modules. Throughout the study, participants will undergo regular safety monitoring including adverse event tracking, laboratory tests, and imaging scans assessed by RECIST criteria. Pharmacokinetic and pharmacodynamic assessments will measure how AZD3470 behaves in the body. Researchers will also evaluate progression-free survival, tumor response, duration of response, and overall survival. Follow-up may continue up to two years after treatment to assess long-term effects and disease control.

Researchers are evaluating orelabrutinib, a brain-penetrating BTK inhibitor, in adults with Primary Progressive Multiple Sclerosis PPMS. This phase 3, randomized, double-blind, parallel-group, multicenter study compares orelabrutinib to placebo to assess its efficacy and safety in treating PPMS. About 705 participants aged 18 to 60 years will be enrolled globally with a 21 randomization favoring orelabrutinib. Participants will receive either oral orelabrutinib or a matching placebo. Treatment will last approximately 30 to 60 months, with a minimum of 12 months on study drug. The study includes two groups one receiving orelabrutinib and the other receiving placebo, both administered orally. The trial design is intended to monitor long-term effects and progression. During the study, participants will undergo regular assessments including disability progression measured over 12 weeks and up to approximately 120 weeks. Evaluations include MRI scans to monitor lesions, timed walking and hand function tests, cognitive testing, and safety assessments such as monitoring adverse events. The study will closely follow participants for up to 5 years to understand the impact of the treatment on disease progression and safety.

This trial investigates orelabrutinib, a brain-penetrating BTK inhibitor, in patients with non-active Secondary Progressive Multiple Sclerosis SPMS. It is a phase 3, randomized, double-blind, multicenter study comparing the effects and safety of orelabrutinib against a placebo. The study will enroll about 990 participants worldwide, focusing on those with SPMS who have not had recent relapses. Participants will be randomly assigned in a 21 ratio to receive either oral orelabrutinib daily or a placebo. After a screening period of up to 4 weeks, the treatment period will last from approximately 24 to 60 months, with a minimum of 12 months treatment. Those who experience confirmed disability progression may enter a 2-year open-label phase receiving orelabrutinib. A 4-week safety follow-up will occur for those who discontinue treatment before study end or do not enter long-term safety monitoring. During the study, participants will have assessments including disability progression measured over 24 weeks, MRI scans, and various functional tests up to about 120 weeks. Researchers will monitor safety and tolerability throughout. Participants will have a final end-of-study visit within 4 weeks after study completion, with ongoing treatment or follow-up depending on eligibility for long-term safety studies.

This research aims to evaluate the safety and effectiveness of combining venetoclax, isatuximab, and dexamethasone for patients with relapsed or refractory multiple myeloma MM who have the t1114 chromosomal marker. MM is a cancer of B-cells that often becomes resistant to treatment, requiring new therapies. Venetoclax targets the BCL-2 protein, which is highly expressed in patients with t1114, while isatuximab is an antibody therapy targeting CD38, both of which have shown promise in prior studies. Participants receive venetoclax orally at 400 mg daily for 28 days per cycle, dexamethasone 40 mg intravenously once a week with some doses possibly given by mouth, and isatuximab intravenously on days 1, 8, 15, and 22 during the first cycle, then on days 1 and 15 in subsequent 28-day cycles. This open-label phase 2 trial focuses on patients who have had at least three prior therapies and currently show disease progression. The study aims to determine safety by tracking side effects and dose-limiting toxicities. During the study, participants will be monitored for treatment-emergent adverse events and response rates over up to 54 months. Researchers will assess measures such as overall response rate, clinical benefit rate, progression-free survival, time to progression, and overall survival. Regular laboratory tests, imaging, and clinical evaluations will be conducted to follow disease status and safety throughout treatment and follow-up periods.

This trial investigates the effectiveness and safety of two treatment combinations for people with relapsed or refractory multiple myeloma who have received one to three prior treatments and were previously treated with lenalidomide. It compares mezigdomide, bortezomib, and dexamethasone MeziVd against pomalidomide, bortezomib, and dexamethasone PVd to see which is better for this condition. The study is a Phase 3, randomized, open-label trial sponsored by Celgene. Participants receive either the MeziVd combination or the PVd combination, with specified doses given on certain days according to the study plan. These treatments are given as drugs, and participants are randomly assigned to one of these two groups to compare their effects. The study will continue for up to approximately five years to evaluate long-term outcomes. During the study, participants will be monitored regularly through various assessments including measuring disease progression, survival, response to treatment, and quality of life using specific questionnaires EORTC QLQ-C30 and QLQ-MY20. Blood samples may be checked for drug levels, and adverse events will be tracked. The main focus is progression-free survival, measured from randomization until disease worsening or death. Participants health and responses will be followed for up to five years, with ongoing visits and evaluations throughout this period.

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

Researchers are evaluating the 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 understand how well this combination works and to characterize its safety, tolerability, pharmacokinetics, and pharmacodynamics. Participants receive cemsidomide orally once daily for 14 days followed by 14 days off in each 28-day cycle. Dexamethasone is taken orally once weekly on Days 1, 8, 15, and 22 of each cycle. Treatment continues in 28-day cycles until discontinuation criteria are met. During the study, participants undergo regular assessments to measure response rates, duration and time to response, progression-free survival, and overall survival. Safety is monitored through reporting of adverse events and laboratory tests. The study also tracks cemsidomide plasma levels. Participation may last up to approximately 43 months, with safety follow-up occurring within about 30 to 35 days after the last dose.