Shibukawa

Researchers are evaluating the effectiveness of JNJ-79635322 in adults with Relapsed or Refractory Multiple Myeloma RRMM, a type of cancer affecting plasma cells. This study focuses on participants who have already undergone at least three previous treatments, including specific therapies such as proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. The study is conducted in a Phase 2, open-label format to assess how well this treatment works in this patient group. Participants will receive JNJ-79635322 through injections under the skin. The study involves a single group where all participants receive this investigational drug. The treatment period lasts up to two years and nine months, during which the medications effects and participants responses are closely monitored. Throughout the study, participants will undergo regular assessments to measure various outcomes, including overall response rate, survival times, symptom changes, and quality of life using specialized questionnaires. Researchers will also monitor safety by tracking adverse events and checking for antibodies against the drug. The total participation duration may last up to nearly three years, allowing comprehensive evaluation of both effectiveness and safety over time.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations teclistamab with daratumumab and lenalidomide Tec-DR, and talquetamab with daratumumab and lenalidomide Tal-DR, against the standard treatment of daratumumab, lenalidomide, and dexamethasone DRd. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

Researchers are studying multiple myeloma, a type of blood cancer, to see if the drug elranatamab, alone or combined with daratumumab, can offer more benefits compared to a combination therapy of daratumumab, pomalidomide, and dexamethasone. This Phase 3 clinical trial focuses on people who have already been treated for multiple myeloma, including with lenalidomide. The study also evaluates the safety and activity of elranatamab with daratumumab and assesses infection protection measures for participants. The trial has three parts. Part 1 tests different doses of elranatamab combined with daratumumab to check safety and activity. In Part 2, participants are randomly assigned to one of three groups elranatamab alone, elranatamab plus daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 examines how increased infection prevention affects those treated with elranatamab alone or with daratumumab. Treatments are given until the disease worsens, side effects become unacceptable, or participants choose to stop. Participants will be monitored for side effects, disease progression, and overall response using standardized criteria from the International Myeloma Working Group. Safety is closely watched, especially in early treatment phases, and quality of life is assessed with questionnaires. Outcome measures include progression-free survival, response rates, adverse events, and lab results. Participant involvement may last up to 51 months with regular evaluations during the study.

Researchers are evaluating linvoseltamab, an experimental drug also called REGN5458, in adults with multiple myeloma that has returned or needs treatment again after one to four prior therapies. The study compares linvoseltamab to a combination of three cancer drugs elotuzumab, pomalidomide, and dexamethasone EPd. This phase 3 study aims to assess the safety and effectiveness of linvoseltamab versus EPd in participants who have standard treatment options available and have previously received certain therapies including lenalidomide and a proteasome inhibitor. Participants are randomly assigned to one of two groups one receiving linvoseltamab by intravenous infusion, and the other receiving the EPd combination, with elotuzumab given by infusion and pomalidomide and dexamethasone given by mouth or infusion. The study focuses on how long participants benefit from the treatments, the degree of tumor response, side effects, survival, and pain improvement. During the study, participants will undergo regular assessments including disease response evaluations based on established criteria, safety monitoring, and patient-reported outcomes like pain and quality of life questionnaires. The primary measure is progression-free survival over up to about five years. Researchers will also track overall survival, adverse events, antibody responses, and other health status measures. Participation involves treatment, follow-up visits, and ongoing monitoring to understand the treatments impact.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating a medicine called elranatamab in people with multiple myeloma MM, a type of cancer. This study compares elranatamab to other commonly used combination therapies for MM that has returned or not responded to previous treatments. Participants must be 18 years or older and have received prior treatments, including an anti-CD38 antibody and lenalidomide. The study is a phase 3, randomized trial sponsored by Pfizer. Participants will be randomly assigned to receive either elranatamab alone or one of several combination therapies chosen by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, with possible adjustments later. The combination therapies include two to three medicines taken by mouth or given by injection or infusion at the clinic. Treatment continues until the multiple myeloma stops responding. During the study, participants attend regular visits to monitor their response and side effects. Follow-up continues after treatment ends through telephone contacts or visits. Researchers will measure outcomes such as progression-free survival, overall survival, response rates, duration of response, and quality of life over approximately five years. Safety monitoring includes tracking adverse events and laboratory results throughout and after treatment.

Researchers are conducting a Phase III, multisite, randomized, double-blinded trial to compare pumitamig BNT327 combined with chemotherapy etoposide and carboplatin against atezolizumab combined with the same chemotherapy in participants with previously untreated extensive-stage small-cell lung cancer ES-SCLC. The study aims to evaluate treatment safety and effectiveness, including overall survival and progression-free survival. The study includes two stages Stage 1 has two treatment arms with different doses of pumitamig and one control arm receiving atezolizumab, while Stage 2 has one treatment arm with a different pumitamig dose and a control arm. Treatment involves intravenous infusions of the study drugs and chemotherapy. Participants may switch from carboplatin to cisplatin if carboplatin is not tolerated. Each stage consists of a screening period, an induction and maintenance treatment period lasting up to 2 years or until disease progression or other endpoints, followed by a safety and survival follow-up phase. Participants undergo screening for eligibility before randomization. During the study, researchers monitor overall survival up to approximately 46 months, progression-free survival, response rates, adverse events, and quality of life through questionnaires. Safety follow-up visits occur after treatment ends. The total participation time may extend over several years, including treatment and follow-up assessments to evaluate long-term outcomes and safety.

Researchers are studying first-line treatment options for participants with non-small cell lung cancer NSCLC in this Phase 23, multisite, randomized, open-label trial. The study includes two substudies based on NSCLC histological subtypes, which have different chemotherapy standards. This design allows evaluation of pumitamig BNT327 combined with chemotherapy and other investigational agents in participants with advanced NSCLC who have not received prior systemic treatment. Participants are randomized to receive one of two dose levels of pumitamig plus chemotherapy during the Phase 2 part of each substudy. In Phase 3, an independent data monitoring committee and a blinded independent central review will oversee safety and tumor assessments. Treatments include pumitamig combined with carboplatin and either pemetrexed or paclitaxel, or pembrolizumab with the same chemotherapies as active comparators. All drugs are given by intravenous infusion. The study period for each participant may last up to 64 months. Throughout the study, participants undergo regular tumor assessments and safety monitoring, including evaluation of adverse events, response rates, progression-free survival, and quality of life using validated questionnaires. Data on dose adjustments and treatment discontinuations are collected. Follow-up continues up to five years to assess long-term outcomes and survival. Participants receive detailed evaluations to understand treatment effects and safety over time in this comprehensive lung cancer trial.