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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.
Full 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.
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Inclusion criteria
Multiple myeloma diagnosed according to standard criteria, without prior anti-myeloma treatment at study entry. Both transplant eligible and ineligible patients may be included.
Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
Males and females ≥ 18 years of age or > country's legal age for adult consent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
Written informed consent in accordance with federal, local and institutional guidelines
Exclusion criteria
Female patients who are lactating or pregnant
Multiple Myeloma of IgM subtype
Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
POEMS syndrome
Plasma cell leukaemia or circulating plasma cells ≥ 2 x 109/L
Waldenstrom's Macroglobulinaemia
Patients with known amyloidosis
Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting bortezomib treatment
Focal radiation therapy within 7 days prior to start of treatment. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of treatment
Immunotherapy (excluding steroids) 21 days prior to start of treatment
Major surgery (excluding kyphoplasty) within 28 days prior to start of treatment
Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
Patients with known cirrhosis
Second malignancy within the past 3 years except:
Patients with myelodysplastic syndrome
Patients with steroid, cyclophosphamide, bortezomib, lenalidomide or thalidomide hypersensitivity
Patients with a calculated creatinine clearance less than 30ml/min by the Cockroft Galt method.
Prior treatment with Bortezomib
Contraindication to any of the required concomitant drugs or supportive treatments
Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
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Central trial contact
Wee Joo Chng, Prof; Sanjay de Mel, Dr
Data sourced from clinicaltrials.gov
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