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Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy...
NRG Oncology
Breast Cancer
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with estrogen... expand
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). Type: Interventional Start Date: Aug 2023 |
Ridge Preservation With FDBA (Freeze Dried Bone Allograft) Using Dexamethasone vs. Saline
The University of Texas Health Science Center at San Antonio
Bone Graft
Tooth Extraction
Following the removal of a tooth, a bone graft is often placed in the socket to try to
maintain the volume of bone that was there when the tooth was present so that the bone
does not "shrink". The bone graft is kept in place with a small piece of material over
the top of the tooth socket and with... expand
Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation, including bone allografts (bone grafts derived from a human tissue donor). These bone allografts are dehydrated (dried) during processing. Before using the material in the socket, the material is re-hydrated (wetted). The most common hydrating (wetting) agent is normal saline (sterile salt water), but other hydrating agents such as blood can also be used. The bone allograft used in this study is Food and Drug Administration (FDA) approved. Type: Interventional Start Date: Sep 2024 |
Long-Term Sequelae of SARS-COV-2 Infection: Diabetes Mellitus
The University of Texas Health Science Center at San Antonio
COVID-19
Diabete Mellitus
Hospitalized patients with severe COVID-19 have an increased incidence of insulin
resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt
type 2 diabetes (T2D) compared to non-hospitalized patients with COVID-19 and COVID-19
negative individuals on long-term follow up. expand
Hospitalized patients with severe COVID-19 have an increased incidence of insulin resistance, impaired beta cell function, glucose intolerance (prediabetes), and overt type 2 diabetes (T2D) compared to non-hospitalized patients with COVID-19 and COVID-19 negative individuals on long-term follow up. Type: Observational Start Date: Jul 2023 |
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants
The University of Texas Health Science Center at San Antonio
Type 2 Diabetes Mellitus in Obese
Heart Failure With Preserved Ejection Fraction
Our goal of the study is to learn the effects of the diabetes medication named
Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question
it aims to answer are:
1. To demonstrate that impaired mitochondrial function leading to reduced ATP
generation plays a... expand
Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are: 1. To demonstrate that impaired mitochondrial function leading to reduced ATP generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (HFpEF) in obese type 2 diabetic (T2D) individuals. 2. To demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content. Type: Interventional Start Date: Jul 2023 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation...
University of Minnesota
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low... expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Shockwave Medical, Inc.
Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate
real-world clinical evidence associated with coronary IVL in a population of female
subjects with calcified coronary artery disease. expand
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease. Type: Observational Start Date: May 2023 |
Multisite Advancement of Research on Chronic Posttraumatic Headache
The University of Texas Health Science Center at San Antonio
Posttraumatic Headache
Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic
brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral
Therapy for PTH has been shown to significantly improve disability outcomes in veterans
with persistent PTH when delivered in-person.... expand
Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-person. Telemedicine platforms can dramatically increase access to evidence-based care. However, whether CBT for PTH retains its effectiveness when delivered through a telemedicine platform has yet to be established. The purpose of this 3-arm randomized clinical trial is to compare Clinic-based Cognitive-Behavioral Therapy (CCBT) to Telemedicine-based Cognitive Behavioral Therapy (TCBT) and to treatment as usual (TAU) in 525 service members and veterans with chronic posttraumatic headaches (PTH) at 3 VA medical centers and 4 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points. Type: Interventional Start Date: Aug 2023 |
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX)...
Alliance for Clinical Trials in Oncology
Locally Advanced Rectal Carcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
This phase II trial compares the effect of irinotecan versus oxaliplatin after
long-course chemoradiation in patients with stage II-III rectal cancer. Combination
chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and
oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin,... expand
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Type: Interventional Start Date: Dec 2022 |
A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab...
BeiGene
Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
This is a Phase 1b/2 study to investigate the efficacy and safety of LBL-007 plus
Tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine to
participants with colorectal cancer. expand
This is a Phase 1b/2 study to investigate the efficacy and safety of LBL-007 plus Tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine to participants with colorectal cancer. Type: Interventional Start Date: Jan 2023 |
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small...
Daiichi Sankyo
Metastatic Non Small Cell Lung Cancer
This study is designed to assess the efficacy and safety of datopotamab deruxtecan
(Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with
pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced
or metastatic non-squamous non-small cell... expand
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Type: Interventional Start Date: Jan 2023 |
Rapamycin - Effects on Alzheimer's and Cognitive Health
The University of Texas Health Science Center at San Antonio
Mild Cognitive Impairment
Alzheimer Disease
This study will evaluate the safety, tolerability, and feasibility of 12 month oral
rapamycin treatment in older adults with amnestic mild cognitive impairment (aMCI) and
early stage Alzheimer's disease (AD). expand
This study will evaluate the safety, tolerability, and feasibility of 12 month oral rapamycin treatment in older adults with amnestic mild cognitive impairment (aMCI) and early stage Alzheimer's disease (AD). Type: Interventional Start Date: Aug 2021 |
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
American Thrombosis and Hemostasis Network
Hematologic Disorder
Bleeding Disorder
Connective Tissue Disorder
Hemophilia
Thrombosis
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN)
clinical studies, the number of new therapies for all congenital and acquired hematologic
conditions, not just those for bleeding and clotting disorders, is increasing
significantly. Some of the recently FDA-approved... expand
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Type: Observational Start Date: Sep 2020 |
Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab...
Merck Sharp & Dohme LLC
Melanoma
Substudy 02B is part of a larger research study where researchers are looking for new
ways to treat advanced melanoma that has not been treated before. The larger study is the
umbrella study. Researchers want to know if adding other treatments to pembrolizumab can
treat advanced melanoma. The goals... expand
Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn: - About the safety and how well people tolerate pembrolizumab given with other treatments - How many people have melanoma that responds (gets smaller or goes away) to treatment Arm 1: Pembrolizumab + Vibostolimab was added in the base protocol on 13-Nov-2019, and enrollment into this arm has been completed. Arm 2: Pembrolizumab was added in the base protocol on 13-Nov-2019, and enrollment stopped prematurely on 15-Aug-2022. Arm 3: Coformulation Pembrolizumab/Quavonlimab was added in Amendment 01 on 20-Oct-2020, and enrollment stopped prematurely on 15-Aug-2022. Arm 4: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib was added in Amendment 01 on 20-Oct-2020, and enrollment is ongoing. Arm 5: Coformulation Favezelimab/Pembrolizumab, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA), and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab were added in Amendment 04 on 10-May-2023, and enrollment for these arms will be initiated in July 2023. Type: Interventional Start Date: Jul 2020 |
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Agenus Inc.
Advanced Cancer
Angiosarcoma
Colorectal Cancer Without Liver Metastases
Endometrial Cancer
Fibrolamellar Carcinoma
This study is an open-label, Phase 1, multicenter study to evaluate the safety,
tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel
fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte
antigen 4 (anti-CTLA-4) human monoclonal antibody... expand
This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab. Type: Interventional Start Date: Apr 2019 |
Clinical Procedures to Support Research in ALS
University of Miami
Amyotrophic Lateral Sclerosis
ALS-Frontotemporal Dementia
Primary Lateral Sclerosis
Progressive Muscular Atrophy
The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize
information collected in the medical record to learn more about a disease called
amyotrophic lateral sclerosis (ALS) and related disorders. expand
The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders. Type: Observational Start Date: Feb 2018 |
Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation
University of Alberta
Lung Transplant Rejection
Objective: To evaluate the potential impact of molecular phenotyping of transbronchial
biopsies in lung transplant recipients with allograft dysfunction, and the potential for
developing a safer endobronchial mucosal biopsy format. expand
Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format. Type: Observational Start Date: May 2016 |
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
The University of Texas Health Science Center at San Antonio
Post-bariatric Surgery
The overall goal of this project is to understand the mechanisms by which gastric bypass
surgery improves glucose metabolism.
The central hypothesis guiding this project is that the reconfiguration of intestinal
transit with the Roux-en-Y will increase the release of insulinotropic GI hormones,
termed... expand
The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism. The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims. 1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp. 2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals. 3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery. Type: Interventional Start Date: Nov 2005 |
A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
Cognito Therapeutics, Inc.
Alzheimer Disease
Alzheimer Disease 1
Alzheimer Disease 2
Alzheimer Disease 3
Alzheimer Disease, Early Onset
This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of
sensory stimulation in subjects with mild to moderate Alzheimer's disease. Up to
approximately 600 subjects will be randomized to 12 months of daily treatment with either
Active or Sham Sensory Stimulation Systems.... expand
This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Up to approximately 600 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE). Type: Interventional Start Date: Dec 2022 |
Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
The University of Texas Health Science Center at San Antonio
Transgender Persons
The study will test:
1. whether estrogen treatment in transwomen is associated with improved insulin
sensitivity and beta cell function
2. whether testosterone treatment in transmen is associated with worsening insulin
sensitivity and beta cell function
3. whether estrogen... expand
The study will test: 1. whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function 2. whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function 3. whether estrogen therapy leads to enhanced immune response in older transwormen Type: Interventional Start Date: Jun 2020 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk...
NRG Oncology
Ovarian Carcinoma
This study evaluates how well two surgical procedures (bilateral salpingectomy and
bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salpingo-oophorectomy... expand
This study evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Observational Start Date: Sep 2020 |
Project: Every Child for Younger Patients With Cancer
Children's Oncology Group
Adrenal Gland Pheochromocytoma
Carcinoma In Situ
Central Nervous System Neoplasm
Childhood Immature Teratoma
Childhood Langerhans Cell Histiocytosis
This study gathers health information for the Project: Every Child for younger patients
with cancer. Gathering health information over time from younger patients with cancer may
help doctors find better methods of treatment and on-going care. expand
This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care. Type: Observational Start Date: Nov 2015 |
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With...
National Cancer Institute (NCI)
Ganglioneuroblastoma, Nodular
Neuroblastoma
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy
along with standard of care surgical resection of the primary tumor, radiation, stem cell
transplantation, and immunotherapy works for treating children with newly diagnosed
high-risk neuroblastoma. Dinutuximab... expand
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma. Type: Interventional Start Date: Apr 2024 |
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple...
Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with
relapsing multiple sclerosis (RMS) expand
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Type: Interventional Start Date: Dec 2021 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer
screening and may help reduce the need for... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant...
SWOG Cancer Research Network
Plasma Cell Myeloma
This phase III trial compares three-drug induction regimens followed by double-or
single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in
patients who are not receiving a stem cell transplant and are considered frail or
intermediate-fit based on age, comorbidities,... expand
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma. Type: Interventional Start Date: Oct 2023 |
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