CURATE.AI Optimized Modulation for Multiple Myeloma

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical trial applying CURATE.AI, a Phenotypic Precision Medicine (PPM) platform, to Bortezomib, Thalidomide and Cyclophosphamide dosing in multiple myeloma patients to show improvement in response.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Collaborator: National University, Singapore
• Treatments: BB 1101; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone acetate; Thalidomide

Criteria

Inclusion Criteria:

1. Adults diagnosed with multiple myeloma diagnosed according to standard criteria, without prior anti-myeloma treatment at study entry

2. Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)a.

1. Serum M-protein = 0.5g/dL,or

2. b. 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

3. Males and females = 21 years of age or > country's legal age for adult Consent

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

5. Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:

1. Absolute neutrophil count (ANC) = 1,000/mm3 and platelet = 50,000/mm3 (= 30,000/mm3 if myeloma involvement in the bone marrow is >50%)

2. Total bilirubin = 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST = 3 xULN.

3. Calculated creatinine clearance = 45mL/min or creatinine < 3mg/dL.

6. Written informed consent in accordance with federal, local and institutional guidelines

Exclusion Criteria:

1. Female patients who are lactating or pregnant

2. Multiple Myeloma of immunoglobulin M subtype

3. Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained

4. POEMS syndrome

5. Plasma cell leukemia or circulating plasma cells = 2 x 109/L

6. Waldenstrom's Macroglobulinaemia

7. Patients with known amyloidosis

8. Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting pomalidomide treatment

9. 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

10. Immunotherapy (excluding steroids) 21 days prior to start of treatment

11. Major surgery (excluding kyphoplasty) within 28 days prior to start of treatment

12. 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

13. 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)

14. Patients with known cirrhosis

15. Second malignancy within the past 3 years except:

1. Adequately treated basal cell or squamous cell skin cancer,

2. Carcinoma in situ of the cervix.

3. Breast carcinoma in situ with full surgical resection

16. Patients with myelodysplastic syndrome

17. Patients with steroid, bortezomib, cyclophosphamide or thalidomide hypersensitivity

18. Prior treatment with Bortezomib

19. Ongoing graft-versus-host disease

20. Patients with pleural effusions requiring thoracentesis or ascites requiring aracentesis within 14 days prior to starting treatment

21. Contraindication to any of the required concomitant drugs or supportive treatments

22. Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent.