NCT03759093

CURATE.AI Optimized Modulation for Multiple Myeloma

Phenotypic Personalized Medicine: Systematically Optimized Combination Therapy in Multiple Myeloma Using CURATE.AI

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In conventional combination chemotherapy, drug doses are typically determined using dose escalation to reach a maximum tolerated dose (MTD) or via dose expansion to identify suitable regimen administration guideline, and the combinations are subsequently administered at fixed doses. During the course of treatment, the patient's response to therapy evolves and changes due to the time-dependent, dose dependent, and patient-specific nature of drug synergy and resulting efficacy and tolerability. To overcome this challenge, we have developed CURATE.AI, a Phenotypic Precision Medicine (PPM) platform, which has been clinically validated and used to prospectively optimize patient liver transplant immunosuppression, and tuberculosis therapy, among other indications. In this study, CURATE.AI may improve patient response by providing dose recommendations for Bortezomib, Thalidomide, Cyclophosphamide and Lenalidomide to the clinical team over the course of the patient's treatment.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib	Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
DRUG	Cyclophosphamide	Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
DRUG	Dexamethasone	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	Bortezomib	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	Cyclophosphamide	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	Dexamethasone	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	Lenalidomide	Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
DRUG	Lenalidomide	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.

Timeline

• Start date: 2023-09-10
• Primary completion: 2025-09-10
• Completion: 2025-09-10
• First posted: 2018-11-29
• Last updated: 2023-09-06

Locations

1 site across 1 country: Singapore