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Tests treatment safety and results for Multiple Myeloma Refractory
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)?
Liposomal Curcumin (LipoCurc) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma refractory.
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 purpose of this study is to test the safety of in investigational drug called Liposomal curcumin (LipoCurc) and to find the highest dose that can be given without causing very severe side effects. To do this participants are given LipoCurc and are watched very closely to see what side effects they have and to make sure the side effects are not severe.
- 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.
- Relapsed and/or refractory MM with:
- Documented evidence of progressive disease (PD) after achieving at least stable disease (SD) for ≥ 1 cycle during a previous MM treatment (i.e...
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.
- Patients with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the patient's illness. The patient must...
- 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;
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.
- Relapsed and/or refractory MM with:
- 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). OR Disease progression during or within 60 days from the end...
- 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
- Patients with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
- transplant was \> 12 weeks prior to study enrolment
- no active infection
- Patients with measurable disease defined as at least one of the following (these baseline laboratory studies for determining eligibility must be obtained within 28 days prior to start of study drug):
- 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...
- The following laboratory results must be met within 7 days of first study drug administration:
- 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. Patients may not have received a platelet transfusion within 72 hours prior to the...
- Hemoglobin ≥ 80 g/L. Patients may receive red blood cell (RBC) transfusions in accordance with institutional guidelines to meet this criterion. Patients may not have received a red blood cell (RBC) transfusion within 72...
- 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.
- Patients with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the patient's illness. The patient must not be receiving active therapy, other than hormonal therapy for this...
- 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.
- Evidence of cardiovascular risk including any of the following:
- 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. Presence of hepatitis B surface antigen (HBsAg) or positive HBV PCR test at screening or within 3 months prior to...
- 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's taking place
- Toronto, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.