A5083321359- Multiple Myeloma Research and Treatments
- Health Systems, Economic Evaluations, Quality of Life
- Cancer Genomics and Diagnostics
- Economic and Financial Impacts of Cancer
- Statistical Methods in Clinical Trials
- Biomedical Ethics and Regulation
- Cancer Treatment and Pharmacology
- CAR-T cell therapy research
- Frailty in Older Adults
- Protein Degradation and Inhibitors
- Hemoglobinopathies and Related Disorders
- Iron Metabolism and Disorders
- Nutrition and Health in Aging
- Ethics in Clinical Research
- Erythropoietin and Anemia Treatment
- Acute Lymphoblastic Leukemia research
- Multiple and Secondary Primary Cancers
- Science, Research, and Medicine
- Occupational and environmental lung diseases
- Peptidase Inhibition and Analysis
- Global Cancer Incidence and Screening
- Breast Cancer Treatment Studies
- Lung Cancer Treatments and Mutations
- Pharmaceutical Economics and Policy
- Myeloproliferative Neoplasms: Diagnosis and Treatment
United States Food and Drug Administration
2017-2024
Center for Drug Evaluation and Research
2017-2024
Duke Medical Center
2014
Cancer Center of Western Wisconsin
2014
Institute for Advanced Studies in Aging and Geriatric Medicine
2014
University of Maryland, Baltimore
2014
Mayo Clinic in Arizona
2014
University of Illinois Chicago
2014
Illinois College
2014
Harvard University
2014
10009 Background: Older adults are a growing segment of our oncology population, with an expected increase in cancer incidence 67% from 2010 to 2030 people age 65 and older. However, older have been proportionally underrepresented clinical trials. We sought analyze the age-related enrollment patients onto trials supporting registration new drugs or indications approved by US Food Drug Administration 2005 2015. Methods: This study involved retrospective analyses demographic data enrolled...
In March 2021, the FDA approved idecabtagene vicleucel, a chimeric antigen receptor T-cell therapy targeting B-cell maturation (BCMA), for adult patients with relapsed/refractory multiple myeloma (RRMM) after ≥4 lines of including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 mAb. Approval was based on overall response rate (ORR), complete (CR) rate, duration (DOR) in 100 RRMM treated vicleucel single-arm trial. Patients received single infusion preceded by lymphodepleting...
Abstract African Americans (AAs) have a higher incidence of multiple myeloma (MM) than White patients. Mortality is also in AAs compared with more commonly immunoglobulin H translocations t(11;14) and t(14;16) We sought to characterize the demographic representation MM clinical trials evaluate outcomes based on race ethnicity. conducted pooled analysis all submitted US Food Drug Administration (FDA) support approval therapeutic between 2006 2019. Demographic characteristics were analyzed...
In February 2022, the FDA approved ciltacabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen, for adult patients with relapsed/refractory multiple myeloma after ≥4 lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 monoclonal antibody. Approval was based on overall response rate (ORR), complete (CR) rate, duration (DoR) in 97 single-arm, open-label, multicenter phase 2 trial (CARTITUDE-1...
The development of novel agents has transformed the treatment paradigm for multiple myeloma, with minimal residual disease (MRD) negativity now achievable across entire spectrum. Bone marrow-based technologies to assess MRD, including approaches using next-generation flow and sequencing, have provided real-time clinical tools sensitive detection monitoring MRD in patients myeloma. Complementary liquid biopsy-based assays are quickly progressing some, such as mass spectrometry methods, being...
Changes that accompany older age can alter the pharmacokinetics (PK), pharmacodynamics (PD), and likelihood of adverse effects (AEs) a drug. However, adults, especially oldest or those with multiple chronic health conditions, polypharmacy, frailty, are often under-represented in clinical trials new drugs. Deficits current conduct evaluation drugs for adults potential steps to fill knowledge gaps presented this communication. The most important step is increase trial enrollment who...
Abstract On August 5, 2020, the FDA granted accelerated approval to belantamab mafodotin-blmf (BLENREP; GlaxoSmithKline) for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and immunomodulatory agent. Substantial evidence effectiveness was obtained from phase II, multicenter DREAMM-2 trial. Patients mafodotin 2.5 3.4 mg/kg intravenously once every 3...
Multiple myeloma (MM) in patients aged greater than 80 years poses an increasingly common challenge for oncology providers. A multidisciplinary workshop was held which MM-focused hematologists/oncologists, geriatricians, and associated health-care team members discussed the state of research MM therapy, as well themes from geriatric medicine that pertain directly to this patient population. summary statement our discussions is presented here, we highlight several topics. disproportionately...
Abstract Minimal residual disease (MRD) is increasingly used as a prognostic biomarker, measure of clinical efficacy, and guide for treatment decisions in various hematologic malignancies. We sought to characterize MRD data registrational trials malignancies submitted the U.S. Food Drug Administration (FDA) with ultimate goal expanding utility future drug applications. descriptively analyzed collected trials, including type endpoint, assay, compartment(s) assessed, acceptance prescribing...
Abstract On October 25, 2022, the FDA granted accelerated approval to teclistamab-cqyv (TECVAYLI; Janssen Biotech) for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines therapy, including a proteasome inhibitor, an immunomodulatory agent, and anti-CD38 mAb. Substantial evidence effectiveness was obtained from MajesTEC-1 trial, phase I/II, single-arm, open-label, multicenter study. Patients step-up doses teclistamab 0.06 0.3...
A December 2022 law introduced a new expedited withdrawal process for accelerated approvals. The first approval withdrawn with this pathway was that of melphalan flufenamide.