Multiple Myeloma Refractory study: Liposomal Curcumin
Official title Study of the Safety and Usefulness of Liposomal Curcumin in Multiple Myeloma
ClinicalTrials.gov ID: NCT07456605
What this study is testing
What is Liposomal Curcumin (LipoCurc)?
An investigational intravenous infusion being studied as a potential treatment for refractory multiple myeloma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if liposomal curcumin is safe and to find the highest dose that can be given without causing severe side effects.
- Who it's for
- Adults with relapsed or refractory multiple myeloma.
- What's involved
- Participants receive liposomal curcumin and are closely monitored with regular check‑ups and tests to track any side effects. Later participants may receive higher doses than earlier ones.
- Time commitment
- The trial runs for several weeks with multiple clinic visits for dosing and safety monitoring.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be able to understand and voluntarily sign an informed consent form (ICF).
- Must be ≥ 18 years of age at the time of signing the ICF
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM treatment (i.e...
- Previously undergone treatment with at least one immunomodulatory drug (lenalidomide or pomalidomide), one proteasome inhibitor (bortezomib...
You likely can't join if
- Known history of clinically active amyloidosis, POEMS syndrome, or patients with plasma cell leukemia defined as circulating plasma cell count...
- Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with...
- Pregnant or lactating females.
- Adequately treated in situ carcinoma of the cervix uteri or the breast;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- In situ malignancy;
See the full eligibility criteria
Who can join
- Must be able to understand and voluntarily sign an informed consent form (ICF).
- Must be ≥ 18 years of age at the time of signing the ICF
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM).
- Previously undergone treatment with at least one immunomodulatory drug (lenalidomide or pomalidomide), one proteasome inhibitor (bortezomib, ixazomib, carfilzomib) and one anti-CD38 drug (daratumumab or isatuximab).
- No effective standard of care options available
- transplant was \> 12 weeks prior to study enrolment
- no active infection
- Serum M-protein ≥ 0.5 g/dl (≥ 5 g/l)
- Urine M-protein ≥ 200 mg/24 h
- Serum free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) and an abnormal serum free light chain ratio (\ 1.65)
- If the serum protein electrophoresis is unreliable for routine M-protein measurement, quantitative immunoglobulin levels on nephelometry or turbidometry will be followed.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.
- Females of child-bearing potential (FCBP) must have a negative serum pregnancy test and must either commit to continued abstinence from heterosexual intercourse or must abide by birth control requirements as described.
- Men with a female partner of childbearing potential must agree to use effective contraception from the time of first dose of study until 90 days after the last dose of study treatment to allow for clearance of any...
- Able to take oral medications
- All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5) must be ≤Grade 1 at the time of enrollment except for alopecia or be...
- Absolute neutrophil count (ANC) \>1000 cells/dL (1.0 x 10\^9/L). Growth factors cannot be given within 7 days of study drug administration.
- Serum AST and ALT ≤ 3 x upper limit of normal (ULN).
- Creatinine clearance ≥ 20 mL/min either directly measured via 24-hour urine collection or calculated using Cockroft-Gault
- Platelet count ≥ 50 x 109/L. For patients with \> 50% myeloma involvement in the marrow, a platelet count of ≥30 x 109/L is allowed.
- Hemoglobin ≥ 80 g/L. Patients may receive red blood cell (RBC) transfusions in accordance with institutional guidelines to meet this criterion.
- Total bilirubin ≤ 1.5 x ULN, unless known to have Gilbert's disease.
- Albumin ≥ 2.0 g/dL (20 g/L).
- Calcium \<1.2xULN.
What rules you out
- Known history of clinically active amyloidosis, POEMS syndrome, or patients with plasma cell leukemia defined as circulating plasma cell count exceeding 500/uL or 5% of the peripheral blood white cells at the time of...
- Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with patient's safety, obtaining informed consent or compliance to the study...
- Pregnant or lactating females.
- Adequately treated in situ carcinoma of the cervix uteri or the breast;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- In situ malignancy;
- Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen levels off treatment;
- Previous malignancy with no evidence of disease confirmed and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
- QTc interval ≥ 470 msecs.
- Evidence of current clinically significant uncontrolled arrhythmias; including clinically significant ECG abnormalities; including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening.
- Class III or IV heart failure as defined by the New York Heart Association functional classification system
- Uncontrolled hypertension
- Ejection fraction \<40% as determined by echocardiogram
- Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator's assessment).
- Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal or cardiac disease).
- Current or past history of clinically significant CNS disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
- Note that patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed.
- Note that patients with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed.
- Known active infection requiring treatment.
- Receiving systemic immunosuppressive medications (including, but not limited to, azathioprine, methotrexate, and anti-tumor necrosis factor agents), with the exception of corticosteroid treatment \<10mg/day prednisone...
- Evidence of active mucosal or internal bleeding.
- Significant urinary outflow obstruction
- Radiotherapy or systemic therapy (standard or biologic anticancer agent) within 14 days of initiation of study drug treatment.
- Use of an investigational drug within 21 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
- Major surgery within 28 days
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to liposomal curcumin.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.