Viewing Study NCT03759093


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Study NCT ID: NCT03759093
Status: UNKNOWN
Last Update Posted: 2023-09-06
First Post: 2018-11-20
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: CURATE.AI Optimized Modulation for Multiple Myeloma
Sponsor: National University Hospital, Singapore
Organization:

Study Overview

Official Title: Phenotypic Personalized Medicine: Systematically Optimized Combination Therapy in Multiple Myeloma Using CURATE.AI
Status: UNKNOWN
Status Verified Date: 2023-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: