CURATE.AI Optimized Modulation for Multiple Myeloma

NCT03759093 | Unknown Phase 2

• 1 other identifier: 2015/00280
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Response rate

  Complete response (CR), or stringent complete response (sCR), or very good partial response (VGPR), or partial response (PR) based on IMWG criteria at the end of cycle 4

  Up to 16 weeks or at the end of cycle 4 of treatment (each cycle is 28 days)

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  Up to 16 weeks or at the end of cycle 4 of treatment (each cycle is 28 days)

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Dosing of VCD(bortezomib, cyclophosphamide,dexamethasone), VTD (bortezomib,thalidomide, dexamethasone), or VRD (Bortezomib, Lenalidomide, Dexamethasone) combinations according to standard of care

Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethasone; Drug: Thalidomide; Drug: Lenalidomide

CURATE.AI-guided dosing

EXPERIMENTAL

CURATE.AI optimized modulation of bortezomib and cyclophosphamide dosages in the VCD (bortezomib, cyclophosphamide, dexamethasone), bortezomib and thalidomide in the VTD (bortezomib, thalidomide, dexamethasone) or bortezomib and lenalidomide in the VRD (bortezomib, lenalidomide, dexamethasone) combinations

Other: CURATE.AI-Guided dosage modulation; Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Thalidomide; Drug: Dexamethasone; Drug: Lenalidomide

Interventions

Bortezomib DRUG

Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

Also known as: Velcade

Standard of Care

Cyclophosphamide DRUG

Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

Standard of Care

Dexamethasone DRUG

Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

Standard of Care

CURATE.AI-Guided dosage modulation OTHER

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

CURATE.AI-guided dosing

Thalidomide DRUG

Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

Standard of Care

Lenalidomide DRUG

Standard dosing based on product insert and subjected to dose adjustments as determined by clinical care team

Also known as: Revlimid

Standard of Care

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

RECRUITING

Related Publications (1)

• Pantuck, A.J., Lee, D.K., Kee, T., Wang, P., Lakhotia, S., Silverman, M.H., Mathis, C., Drakaki, A., Belldegrun, A.S., Ho, C.M. and Ho, D., 2018. Modulating BET Bromodomain Inhibitor ZEN-3694 and Enzalutamide Combination Dosing in a Metastatic Prostate Cancer Patient Using CURATE. AI, an Artificial Intelligence Platform. Advanced Therapeutics, 1(6), p.1800104.

  BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Cyclophosphamide; Dexamethasone; Thalidomide; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Wee Joo Chng, Prof

CONTACT

67795555; mdccwj@nus.edu.sg

Sanjay de Mel, Dr

CONTACT

67795555; sanjay_widanalage@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Chng Wee Joo

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 29, 2018
• Study Start: September 10, 2023
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)