CURATE.AI Optimized Modulation for Multiple Myeloma

NCT03759093 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03759093 on ClinicalTrials.gov