Kamogawa

Researchers are evaluating how well the drug JNJ-79635322 works compared to an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody in adults with relapsed or refractory multiple myeloma. This phase 3 study includes participants who have received at least three prior treatments including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. The study aims to compare the effectiveness of these two treatments in this patient population. The study involves two treatment groups receiving either JNJ-79635322 or Teclistamab, both given as subcutaneous injections. Participants must have measurable disease and evidence of disease progression or lack of response to their most recent therapy. The study excludes those with certain infections, central nervous system involvement, allergies to the study drugs, recent major surgery, or recent live vaccine receipt. Participants will be monitored for overall response rate and progression-free survival for up to five years and four months. Throughout the study, performance status will be assessed, and participants will be regularly evaluated for safety and treatment response. The total duration of participation and follow-up allows for long-term evaluation of treatment effects and disease progression.

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: * Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept * Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met * The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase * Transition Phase is defined as one Enrollment visit * Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol * Follow-up Phase includes: \- 42 Day Safety Follow-up Visit * During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting \- Long-term Post-treatment Follow-up (LTPTFU) Phase * Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.

Researchers are evaluating an experimental drug called linvoseltamab (REGN5458) for adults with relapsed or refractory multiple myeloma who have had one to four previous treatments and have standard treatment options available. This phase 3 study compares linvoseltamab to a combination of three cancer drugs: elotuzumab, pomalidomide, and dexamethasone (EPd). The study aims to assess the safety and effectiveness of linvoseltamab compared to EPd, including how long participants benefit, tumor response, side effects, survival, and pain improvement. Linvoseltamab is given by intravenous infusion, while the comparison group receives elotuzumab by infusion and pomalidomide capsules and dexamethasone tablets or capsules by mouth or IV. Participants are randomly assigned to receive either linvoseltamab or the EPd combination. The study includes participants who have previously received lenalidomide, a proteasome inhibitor, and in some cases, a CD38 antibody. Treatment continues as per protocol with ongoing monitoring. Participants will undergo regular assessments to evaluate their disease response and side effects. Researchers will monitor progression-free survival for up to approximately five years. Assessments include measuring tumor response, survival, pain levels, and safety. Participants must have measurable disease and adequate organ function, and they will be followed closely to assess how well the treatments work and their safety over time.

Researchers are evaluating treatments for newly diagnosed ANCA-associated vasculitis, a serious disease involving inflammation of small to medium blood vessels. This phase 4 trial compares whether avacopan combined with short-term reduced-dose glucocorticoids and rituximab works as well as a longer 20-week reduced-dose glucocorticoid and rituximab treatment for achieving remission. The study also examines if avacopan lowers relapse rates compared to rituximab maintenance therapy and assesses the long-term safety of avacopan. Participants will be randomly assigned to one of two treatment groups. One group receives avacopan with short-term (up to 4 weeks) reduced-dose prednisolone and rituximab given at the start. The other group receives reduced-dose prednisolone for up to 20 weeks combined with rituximab administered at weeks 0, 26, 52, and 78. The study is open-label and will follow patients for up to 104 weeks to compare remission, relapse, and safety outcomes. Patients will be evaluated at multiple time points from baseline through week 104. Assessments include disease status (remission or relapse), disease activity scores, damage indexes, and adverse events. The main outcome is the proportion of patients achieving remission at 26 weeks. Researchers will monitor long-term safety and relapse rates over two years to better understand the benefits and risks of these treatment approaches.

Researchers are evaluating the early use of a once-daily oral drug called empagliflozin 10 mg in patients hospitalized with acute heart failure (AHF) who are at high risk for serious complications. This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of empagliflozin compared to a matching placebo in this patient group. The trial focuses on patients requiring intravenous diuretic therapy and exhibiting specific clinical signs and biomarker levels related to heart failure severity. Participants are randomly assigned to receive either empagliflozin 10 mg once daily or a placebo shortly after hospital admission. Treatment begins within 12 hours of hospital presentation and continues during the hospitalization period. The study excludes patients with very low kidney function, recent use of similar drugs, certain heart conditions, and other specific medical issues to ensure safety and clear evaluation of the drug's effects. During the study, patients will be closely monitored for outcomes including death, rehospitalization for heart failure, worsening heart failure during the hospital stay, and urine output within 48 hours of treatment start. Researchers will use a combined measure called the win ratio to assess these outcomes over 90 days. Participants will undergo clinical evaluations, laboratory tests, and safety assessments throughout the study period to track the drug's impact and monitor for any adverse events.

Researchers are investigating treatments for walled-off necrosis (WON), a pancreatic fluid collection that develops after four weeks of acute pancreatitis and contains dead tissue. Infected WON can cause serious complications, and while endoscopic ultrasonography (EUS)-guided drainage is the preferred initial treatment, some patients do not improve with this method alone. This trial compares two approaches: performing endoscopic necrosectomy (EN) immediately after EUS-guided drainage versus using a step-up approach where EN is delayed and additional drainage steps are used first. The study aims to determine which method shortens the time to clinical success without increasing risks. Participants will receive EUS-guided drainage within 72 hours of randomization using a specialized stent (lumen-apposing metal stent). In the immediate necrosectomy group, EN is performed during the same session as the drainage, where an endoscope is inserted to directly remove necrotic tissue. In the step-up approach group, additional procedures are delayed for 3 to 4 days after drainage, and further drainage or necrosectomy is only done if symptoms persist. This design allows comparison of treatment duration between immediate and delayed necrosectomy strategies. During the study, patients will be closely monitored for clinical improvement and undergo repeated procedures as needed. Researchers will measure the time it takes from randomization to clinical success over six months. Safety and adverse events will also be tracked. The study includes patients with symptomatic WON who require drainage and are able to undergo endoscopic procedures, with follow-up evaluations conducted at participating hospitals to assess outcomes and any complications.

Researchers are investigating the safety, pharmacokinetics, and early effectiveness of pelabresib when added to ruxolitinib in Japanese adults with myelofibrosis, including primary myelofibrosis and post-polycythemia vera or post-essential thrombocythemia myelofibrosis. This phase 1b, open-label, multicenter study focuses on patients at intermediate-1, intermediate-2, or high risk of the disease who are already on stable ruxolitinib treatment. Participants will first undergo up to 28 days of screening before receiving pelabresib at a fixed dose of 125 mg orally once daily for 14 days within each 21-day cycle, alongside their stable dose of ruxolitinib taken twice daily (5 to 25 mg). Pelabresib treatment continues until disease progression, unacceptable side effects, death, or decisions by the participant or investigator to stop. After treatment ends, a 30-day safety follow-up visit will take place, followed by long-term follow-up visits approximately every 12 weeks for at least three years from the first dose and at least two years after the last dose. During the study, researchers will monitor for dose-limiting toxicities within the first 21 days and track all adverse and serious adverse events throughout the average four-year participation. Safety assessments include monitoring for leukemic transformation during treatment and up to two years after. The study will continue until all participants complete follow-up or pelabresib becomes available through other programs or reimbursement in Japan.