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Clinical Trial News

Dextenza Insert Shows Strong Efficacy in Allergic Conjunctivitis Phase 3 Trial

  • A Phase 3 trial of the dexamethasone intracanalicular insert (Dextenza) met its primary endpoint, significantly reducing ocular itching associated with allergic conjunctivitis.
  • The study demonstrated statistically significant improvements in conjunctival redness and other secondary endpoints, indicating broad relief from allergic conjunctivitis symptoms.
  • Dextenza showed a favorable safety profile, with no serious adverse events reported and a low incidence of treatment-related ocular adverse events.
  • The sustained-release insert offers a preservative-free, physician-administered alternative to traditional eye drops, potentially improving patient compliance and reducing overuse.

A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

NCT04050865CompletedPhase 3
Ocular Therapeutix, Inc.
Posted 8/5/2019

Study Reveals Disparities in Time to Oral Antimyeloma Treatment Initiation

  • A recent study highlights significant delays in filling oral antimyeloma prescriptions compared to overall multiple myeloma treatment initiation.
  • The research identifies administrative burdens and complex processes, such as REMS surveys and specialty pharmacy fills, as contributing factors to these delays.
  • Older age, Black race, inpatient diagnosis, and lower EGFR were identified as independent predictors of delayed oral antimyeloma treatment.
  • These findings underscore the need to address disparities and streamline access to oral antimyeloma medications for newly diagnosed multiple myeloma patients.

Cilta-cel Demonstrates Sustained Survival Benefit in Pretreated Multiple Myeloma

  • Updated data from the CARTITUDE-4 trial shows cilta-cel significantly improves overall survival in lenalidomide-refractory multiple myeloma patients compared to standard of care.
  • At 33.6 months follow-up, the 30-month overall survival rate with cilta-cel was 76.4% versus 63.8% with standard of care, reducing the risk of death by 45%.
  • The progression-free survival rate at 30 months was 59.4% with cilta-cel compared to 25.7% with standard of care, indicating a 71% reduction in disease progression or death.
  • Cilta-cel also demonstrated high overall response rates (84.6%) and minimal residual disease negativity, highlighting its potential to transform the myeloma treatment landscape.

NXC-201 (formerly HBI0101) Multiple Myeloma

NCT04720313Active, Not RecruitingPhase 1
Hadassah Medical Organization
Posted 1/1/2021

Pembrolizumab as Salvage Therapy for the Treatment of Multiple Myeloma in Patients Progressing on CAR-T Cell Therapy

NCT05204160WithdrawnPhase 2
Emory University
Posted 4/11/2022

MM CAR-T to Upgrade Response BMTCTN1902

NCT05032820CompletedPhase 2
Marcelo Pasquini, MD
Posted 1/5/2022

Clinical Study of the Safety and Efficacy of BCMA CAR-NK

NCT05652530RecruitingEarly Phase 1
Shenzhen Pregene Biopharma Co., Ltd.
Posted 11/13/2022

Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel

NCT06523621RecruitingPhase 2
Wake Forest University Health Sciences
Posted 2/28/2025

BCMA-directed CAR-T Cell Therapy in Adult Patients With Multiple Myeloma

NCT04318327TerminatedPhase 1
Novartis Pharmaceuticals
Posted 7/23/2020

A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

NCT05257083RecruitingPhase 3
Stichting European Myeloma Network
Posted 10/10/2023

BCMA Targeted CAR T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma

NCT03070327Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 2/27/2017

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

NCT04181827Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 6/12/2020

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

NCT04960579RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 5/5/2022

Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

NCT05396885Active, Not RecruitingPhase 2
Kite, A Gilead Company
Posted 8/9/2022

Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma

NCT04155749Active, Not RecruitingPhase 1
Kite, A Gilead Company
Posted 12/23/2019

A Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

NCT03758417Active, Not RecruitingPhase 2
Nanjing Legend Biotech Co.
Posted 1/23/2019

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

NCT06413498RecruitingPhase 3
Kite, A Gilead Company
Posted 8/23/2024

Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies

NCT04205409Active, Not RecruitingPhase 2
University of Washington
Posted 6/5/2020

A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)

NCT04196491CompletedPhase 1
Celgene
Posted 5/27/2020

Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

NCT03361748CompletedPhase 2
Celgene
Posted 12/13/2017

Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma

NCT06048250RecruitingPhase 1
City of Hope Medical Center
Posted 4/9/2024

To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL

NCT06045091RecruitingEarly Phase 1
Hrain Biotechnology Co., Ltd.
Posted 7/4/2023

A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma

NCT03548207CompletedPhase 1
Janssen Research & Development, LLC
Posted 6/29/2018

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

NCT04923893Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/19/2021

Evolving Strategies in CLL: Rethinking Continuous BTK Inhibitor Therapy

  • Emerging data suggest that continuous BTK inhibitor therapy in CLL may not always be necessary, challenging traditional treatment approaches.
  • Combinations of BTK inhibitors with BCL-2 inhibitors show promise in achieving deep responses and treatment-free remission in CLL patients.
  • Ongoing trials are investigating BCL2 inhibitor–free, fixed-duration regimens, exploring the potential of time-limited BTK inhibitor plus mAb therapies.
  • Factors like disease genetics, prior treatment, and response depth should guide decisions on stopping BTK inhibitor therapy, alongside patient preferences and tolerance.

A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL

NCT04722172Active, Not RecruitingPhase 2
Memorial Sloan Kettering Cancer Center
Posted 5/21/2021

Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia

NCT04505254RecruitingPhase 2
M.D. Anderson Cancer Center
Posted 8/25/2020

Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia

NCT02756897Active, Not RecruitingPhase 2
M.D. Anderson Cancer Center
Posted 7/7/2016

Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

NCT04608318Active, Not RecruitingPhase 3
German CLL Study Group
Posted 3/1/2021

A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)

NCT04771507RecruitingPhase 1
Jeanette Lundin
Posted 2/23/2018

Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

NCT06333262Active, Not RecruitingPhase 2
Inhye Ahn
Posted 4/22/2024

Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT01886872Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 1/15/2014

Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL

NCT04908228RecruitingPhase 2
Paolo Ghia
Posted 12/13/2021

Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT02048813Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 3/10/2014

High-Dose Vitamin D Supplementation Delays Progression to Multiple Sclerosis in CIS Patients

  • A Phase 3 clinical trial (D-Lay-MS) found that high-dose cholecalciferol (vitamin D) supplementation significantly delayed the progression from clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (MS).
  • The study demonstrated a 34% reduction in disease activity at two years in CIS patients taking high-dose vitamin D compared to placebo, with a nearly doubled median time to disease activity.
  • Cholecalciferol led to significant reductions in new or enlarging lesions and in inflammatory lesions after two years, suggesting its efficacy in early relapsing-remitting MS.
  • High-dose vitamin D supplementation was found to be safe and well-tolerated, supporting its potential as an add-on therapy in the therapeutic strategy for MS.

Efficacy of Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of MS After a Clinically Isolated Syndrome

NCT01817166CompletedPhase 3
Centre Hospitalier Universitaire de Nīmes
Posted 7/16/2013

Niger Launches Malaria Vaccine Campaign to Combat Childhood Mortality

  • Niger has initiated a large-scale vaccination campaign against malaria, starting in the southwestern city of Gaya, a hotspot for the disease.
  • The RTS,S vaccine, produced by GSK, has been integrated into Niger's routine vaccination schedule following its approval in 2022.
  • Malaria accounts for 19% of child deaths in Niger, and the vaccine is estimated to be 75% effective against severe forms of the disease.
  • Niger will continue its anti-malarial strategy by distributing mosquito nets and administering preventive medication to children before the wet season.

Lenalidomide and Obinutuzumab Combination Shows Promise in Relapsed Non-Hodgkin Lymphoma

  • A phase 1/2 trial evaluated lenalidomide plus obinutuzumab in relapsed indolent non-Hodgkin lymphoma, demonstrating a 90% overall response rate.
  • The combination therapy showed a manageable safety profile, with neutropenia and thrombocytopenia being the most common Grade 3 or 4 hematological toxicities.
  • After a median follow-up of 41.7 months, the estimated 4-year progression-free survival rate was 55%, indicating prolonged remission duration.
  • The study suggests lenalidomide with obinutuzumab is highly active in relapsed/refractory indolent B cell NHL, though it lacks a control arm.

Real-World Study Affirms Long-Term Benefits of Anti-VEGF Therapy for Neovascular AMD

  • A recent analysis of the Fight Retinal Blindness SPAIN database highlights the effectiveness of anti-VEGF therapy in treating neovascular age-related macular degeneration (nAMD).
  • The study demonstrates that consistent anti-VEGF treatment can maintain and even improve visual acuity in nAMD patients over several years.
  • Researchers emphasize the importance of early diagnosis and continuous treatment to achieve optimal outcomes and prevent vision loss in nAMD.
  • The findings support the use of real-world data to assess and improve treatment strategies for retinal diseases.

FDA Approves Armour's Mononine, the First Monoclonal Antibody-Purified Hemophilia B Therapy

  • The FDA approved Armour's Mononine on August 20 for preventing and controlling bleeding in Hemophilia B patients with Factor IX deficiency.
  • Mononine, a Coagulation Factor IX, is the first monoclonal antibody-purified Hemophilia B therapy, priced at $1.04 per unit.
  • The therapy is available in single-dose vials of 250, 500, and 1000 IUs, administered at approximately 2.0 ml per minute when reconstituted.
  • Mononine is contraindicated in patients with hypersensitivity to mouse protein; other Factor IX biologics were also recently approved.

EG-70 Shows Promise in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

  • EG-70 (detalimogene voraplasmid) is a novel non-viral gene therapy designed to stimulate anti-tumor immune response in the bladder for BCG-unresponsive NMIBC.
  • Preclinical data demonstrates that mEG-70 treatment activates both innate and adaptive immune responses, remodeling the tumor microenvironment and clearing existing tumors.
  • Phase 1/2 study (LEGEND) interim data suggests a promising safety, tolerability, and efficacy profile, with an overall complete response rate of 73%.
  • Treatment-related adverse events were mostly grade 1/2 and consistent with catheterization and intravesical administration, suggesting good tolerability.

LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve

NCT04752722RecruitingPhase 1
enGene, Inc.
Posted 4/22/2021

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