Status:
UNKNOWN
CURATE.AI Optimized Modulation for Multiple Myeloma
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
National University of Singapore
Conditions:
Multiple Myeloma
Eligibility:
All Genders
21-99 years
Phase:
PHASE2
PHASE3
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...
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 administr...
Eligibility Criteria
Inclusion
- 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)
- Serum M-protein ≥ 0.5g/dL, or
- In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) \> 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
- 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:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is \>50%)
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
- Calculated creatinine clearance ≥ 30mL/min or creatinine \< 3mg/dL.
- Written informed consent in accordance with federal, local and institutional guidelines
Exclusion
- 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:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Breast carcinoma in situ with full surgical resection
- 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
Key Trial Info
Start Date :
September 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03759093
Start Date
September 10 2023
End Date
September 10 2025
Last Update
September 6 2023
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119228