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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
National University Hospital
Singapore, Singapore
RECRUITINGResponse rate
Complete response (CR), or stringent complete response (sCR), or very good partial response (VGPR), or partial response (PR) based on IMWG criteria at the end of cycle 4
Time frame: Up to 16 weeks or at the end of cycle 4 of treatment (each cycle is 28 days)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria.
Time frame: Up to 16 weeks or at the end of cycle 4 of treatment (each cycle is 28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
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
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.
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.
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
Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team
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.