A5065971287- Multiple Myeloma Research and Treatments
- Monoclonal and Polyclonal Antibodies Research
- CAR-T cell therapy research
- Protein Degradation and Inhibitors
- Peptidase Inhibition and Analysis
- Health Systems, Economic Evaluations, Quality of Life
- Economic and Environmental Valuation
- Statistical Methods in Clinical Trials
- Decision-Making and Behavioral Economics
- Cancer Treatment and Pharmacology
- Consumer Market Behavior and Pricing
- Advanced Statistical Methods and Models
- Cancer therapeutics and mechanisms
- Computational Drug Discovery Methods
- Cholinesterase and Neurodegenerative Diseases
- Meta-analysis and systematic reviews
- Cancer Mechanisms and Therapy
- Colorectal Cancer Treatments and Studies
- Efficiency Analysis Using DEA
- Helicobacter pylori-related gastroenterology studies
- Genetic factors in colorectal cancer
- Cancer Genomics and Diagnostics
- Chronic Lymphocytic Leukemia Research
- Optimal Experimental Design Methods
Janssen (United States)
2020-2025
Johnson & Johnson (United States)
2025
Janssen Scientific Affairs (United States)
2025
Johns Hopkins University
2012-2016
PURPOSE Newly approved drugs and combinations treating multiple myeloma (MM) have resulted in substantial improvements patients' survival. To deliver rapid access to newer therapies, an earlier end point expedite clinical trials is needed. Our objective was evaluate the minimal residual disease–negative complete response (MRD-CR) as intermediate for progression-free survival (PFS) overall (OS) newly diagnosed (ND) transplant-eligible (NDTE) patients, ND transplant-ineligible (NDTinE)...
This paper reports guidelines for the content of statistical analysis plans early phase clinical trials, ensuring specification minimum reporting requirements, by detailing extensions (11 new items) and modifications (25 to existing guidance after a review various stakeholders.
8032 Background: Teclistamab (tec; JNJ-64007957) is a BCMA × CD3 T-cell redirecting bispecific antibody under investigation in patients (pts) with RRMM. Daratumumab (dara) CD38 mAb direct on-tumor and immunomodulatory actions. Initial clinical data from the phase 1b multicohort TRIMM-2 study support combination of tec + dara for treatment RRMM, tolerable safety, no overlapping toxicities, promising efficacy. We present updated results additional pts longer follow-up. Methods: Eligible MM...
Abstract Purpose: We designed mathematical models to describe and quantify the mechanisms dynamics of minimal residual disease (MRD) in order better understand these MRD dynamics, inform future treatment design, including when stop or change treatment, extrapolate from current PFS times predict curves. Experimental Design: To model individual sequential data phase III clinical trials (MAIA, CASTOR, POLLUX) using previously developed which would be modified as necessary accurately correspond...
8008 Background: New immunotherapy targets in MM are needed as patients (pts) continue to relapse. The orphan receptor GPRC5D is expressed on malignant plasma cells MM. Talquetamab (JNJ-64407564) a bispecific IgG4 antibody that redirects T cell killing by binding the novel target, GPRC5D, and CD3. We present updated results of talquetamab at recommended phase 2 dose (RP2D) from 1 trial relapsed/refractory Methods: Eligible pts with who had relapsed or refractory disease were intolerant...
Background: Talquetamab (tal; JNJ-64407564) is a first-in-class, bispecific IgG4 antibody that binds both to G protein-coupled receptor family C group 5 member D (GPRC5D), highly expressed on malignant plasma cells but with limited expression in healthy tissue, and CD3 mediate T-cell–activated lysis of GPRC5D+ multiple myeloma (MM) cells. Daratumumab (dara) an anti-CD38 mAb direct on-tumor immunomodulatory actions. Initial clinical results from the phase 1b multicohort TRIMM-2 study...
Background: Teclistamab (JNJ-64007957) is a B-cell maturation antigen (BCMA) × CD3 T-cell redirecting bispecific antibody currently under investigation in patients with relapsed/refractory multiple myeloma (RRMM). Daratumumab CD38-targeting monoclonal direct on-tumor and immunomodulatory mechanisms of action. The preliminary results from the phase 1b multicohort TRIMM-2 study showed tolerable safety no overlapping toxicities, encouraging efficacy, supporting combination teclistamab...
Clinical trials in oncology often involve the statistical analysis of time-to-event data such as progression-free survival or overall to determine benefit a treatment therapy. The log-rank test is commonly used compare from two groups. especially powerful when groups have proportional hazards. However, curves encountered studies that differ one another do not always by having hazards; instances, loses power, and are said “non-proportional hazards”. This non-proportional hazards situation...
Patients with MM continue to relapse on current therapies, stressing the need for new immunotherapy targets. GPRC5D is an orphan receptor that expressed malignant plasma cells in MM. Talquetamab (JNJ-64407564) a bispecific IgG4 antibody binds and CD3, redirecting T cell killing cells. Updated phase 1 results of talquetamab at recommended 2 dose (RP2D) patients RRMM are presented. Eligible had or were intolerant standard therapies. received intravenously (IV; range 0.5–180 μg/kg)...
Abstract Background: Familial adenomatous polyposis (FAP) is the most common hereditary syndrome. It an autosomal dominant inherited disorder characterized by early onset of hundreds to thousands polyps throughout colon. If left untreated, nearly all individuals with this syndrome develop colorectal cancer (CRC) third decade life. Prophylactic colectomy standard care, but remain at risk for malignant transformation duodenal polyps, rectal those who have undergone rectal-sparing surgeries,...