4 mg/ml

DRUG5 trials

Sponsors

Leiden University Medical Center, Stichting Radboud universitair medisch centrum, Leids Universitair Medisch Centrum (LUMC), Medical University Of Warsaw, Fondation Lenval Nice

Conditions

General anesthesiaLight chain amyloidosis (AL amyloidosis) is an incurable plasma cell neoplasm and the most common among a heterogeneous group of over 30 rare and ultra-rare diseases known as amyloidoses. In AL amyloidosis the deposition of amyloid fibrils resulting from misfolded immunoglobulin light chains leads to end-stage failure of the affected organsSEVERE ACUTE TRAUMA-RELATED PAINa 3-week treatment with sargramostim resulted in improved cognitive functiona relationship between high levels of GM-CSF in the synovial fluid and a lower risk of developing Alzheimer's diseasebased on the results of the ANDROMEDA phase III clinical trialclinical trials with opsonizing antibodies are ongoingcyclophosphamide and dexamethasone. The recombinant granulocyte macrophage colony stimulating factor (GM-CSF) sargramostim will be used in this study with the D-VCD regimen. Currently

Phase 2

Phase II, Multicenter Study to Assess Safety and Efficacy of Combination of Sargramostim with D-VCd Therapy (Daratumumab, Cyclophosphamide, Bortezomib, Dexamethasone) in Untreated Patients with Light Chain Amyloidosis

Active, not recruitingCTIS2024-518658-18-00

Medical University Of Warsawa 3-week treatment with sargramostim resulted in improved cognitive function, a relationship between high levels of GM-CSF in the synovial fluid and a lower risk of developing Alzheimer's disease, based on the results of the ANDROMEDA phase III clinical trial +22

Start: 2023-07-26Target: 20Updated: 2025-09-11

RANDOMIZED CONTROLLED STUDY COMPARING SUFENTANIL AND KETAMINE INTRANASALLY IN THE MANAGEMENT OF SEVERE ACUTE TRAUMA-RELATED PAIN IN CHILDREN

Not yet recruitingCTIS2025-521075-31-00

Fondation Lenval NiceSEVERE ACUTE TRAUMA-RELATED PAIN

Target: 116Updated: 2025-09-30

Phase 4

Hypoxic ventilatory response (HVR): Effect of Esketamine

CompletedCTIS2023-504229-37-00

Leiden University Medical Centerhealthy volunteers

Start: 2023-08-04End: 2025-03-14Target: 18Updated: 2023-06-12

(ROAR) Reversal of opioid-induced respiratory depression with opioid antagonists - a pharmacokinetic pharmacodynamic modeling study in opioid naïve individuals and chronic opioid users under real-life conditions

RecruitingCTIS2024-518041-16-00

Leids Universitair Medisch Centrum (LUMC)healthy volunteers, opioid use disorder

Start: 2022-06-15Target: 24Updated: 2024-11-15

Rapid sequence emergence of general Anaesthesia

Not yet recruitingCTIS2024-516415-24-03

Stichting Radboud universitair medisch centrumGeneral anesthesia

Target: 10Updated: 2025-12-02