CURATE.AI Optimized Modulation for Multiple Myeloma
NCT03759093 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-09-06
Summary
Clinical trial applying CURATE.AI, a Phenotypic Precision Medicine (PPM) platform, to Bortezomib, Thalidomide, Cyclophosphamide and Lenalidomide dosing in multiple myeloma patients to show improvement in response.
Conditions
Interventions
- DRUG
-
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
- DRUG
-
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
- DRUG
-
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
- OTHER
-
CURATE.AI-Guided dosage modulation
CURATE.AI-guided modulation of Velcade and Cyclophosphamide dosages for VCD regimen, Velcade and Thalidomide dosages for VTD regimen, and Velcade and Lenalidomide dosages for VRD regimen
- DRUG
-
Thalidomide
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
- DRUG
-
Dose in a range of 0.7,1.0,1.3 mg/m2 subcutaneous (SC) injection on Day 1, 8, 15 ,22 for cycles 1 to 4 , as determined and guided by CURATE.AI and approved by the clinical care team
- DRUG
-
Dosing in a range of 100, 300, 500 mg PO on Day 1, 8, 15, 22 for cycles 1 to 4 as determined and guided by CURATE.AI and approved by the clinical care team.
- DRUG
-
Thalidomide
Dose in a range of 50-200mg PO on day 1-28 for cycles 1 to 4 as determined and guided by CURATE.AI and approved by the clinical care team.
- DRUG
-
40 mg PO on Day 1 ,8 , 15, 22 for cycles 1 to 4, as determined and guided by the clinical care team according to standard of care
- DRUG
-
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
- DRUG
-
Dose in a range of 5-25mg PO on day 1-21 for cycles 1 to 4, as determined and guided by CURATE.AI and approved by the clinical care team.
Sponsors & Collaborators
-
National University of Singapore
collaborator OTHER -
National University Hospital, Singapore
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-10
- Primary Completion
- 2025-09-10
- Completion
- 2025-09-10
Countries
- Singapore
Study Locations
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