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Multiple Myeloma RefractoryPhase 1NCT07456605

Study of the Safety and Usefulness of Liposomal Curcumin in Multiple Myeloma

A Phase 1 study testing Liposomal Curcumin (LipoCurc) in people with Multiple Myeloma Refractory and Multiple Myeloma in Relapse, run by University Health Network, Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Liposomal Curcumin (LipoCurc)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
27 Feb 2026to 2 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 of the most recent MM treatment (i.e., refractory 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). These drugs could have been used in separate regimens or in combination.
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  • 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 (< 0.26 or > 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 altered sperm.
  • 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 deemed to be irreversible (for example, steroid induced cataracts or peripheral neuropathy).
  • 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 platelet count used for eligibility
  • 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 hours prior to the hemoglobin result used for eligibility; use of growth factors is allowed.
  • Total bilirubin ≤ 1.5 x ULN, unless known to have Gilbert's disease.
  • Albumin ≥ 2.0 g/dL (20 g/L).
  • Calcium <1.2xULN.

Who cannot join

  • 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 screening
  • 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 procedures.
  • 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 disease and the disease must be considered medically stable for at least 2 years. The following are allowed:
  • 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;
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  • 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 first dose of study treatment. Participants with positive hepatitis B core antibody (HBcAb) can be enrolled, only if confirmatory negative Hepatitis B DNA is obtained AND patient is on hepatitis B prophylaxis (e.g. tenofovir or entecavir) before first dose of study drugs. Presence of isolated Hep B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing. Patients with HIV with detectable viral load or with AIDS-defining features or illnesses will be excluded.
  • 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 or equivalent within 2 weeks. Inhaled corticosteroids for respiratory diseases are allowed.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guido Lancman, M.D. contact

416-946-2059

Guido.Lancman@uhn.ca

Canada1 site, 1 recruiting

  • University Health Network-Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Guido Lancman, M.D., 416-946-2059, Guido.Lancman@uhn.ca

    Guido Lancman, M.D.

    Recruiting

Other trials in Canada

About this study

Official title: Phase I Study of Safety and Efficacy of Liposomal Curcumin in Relapsed Refractory Multiple Myeloma

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. If the side effects are not severe, then new participants will be given a higher dose of LipoCurc. Participants joining this study later on will get higher doses of LipoCurc than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

Read the detailed description

LipoCurc contains a substance called curcumin. Curcumin is a natural ingredient found in a plant called turmeric, which is a herb used in traditional Indian and Chinese medicine. Curcumin has been shown in the laboratory to have antioxidant (may help prevent damage to cells),anti-inflammatory (may help reduce swelling, redness, or pain), and anti-cancer (can kill multiple myeloma cells) properties. Curcumin supplements participants can buy at a drugstore as pills are not absorbed well by the body. This product has been developed so the body can absorb much more of it through an infusion into the veins.

Being tested
Liposomal Curcumin (LipoCurc)
Keywords
Liposomal Curcumin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal Curcumin (LipoCurc)Drug

    LipoCurc contains a substance called curcumin. Curcumin is a natural ingredient found in a plant called turmeric, which is a herb used in traditional Indian and Chinese medicine. Curcumin has been shown in the laboratory to have antioxidant (may help prevent damage to cells),anti-inflammatory (may help reduce swelling, redness, or pain), and anti-cancer (can kill multiple myeloma cells) properties. Curcumin supplements participants can buy at a drugstore as pills are not absorbed well by the body. This product has been developed so the body can absorb much more of it through an infusion into the veins.

Study groups in NCT07456605
Study groupRoleWhat they receive
Dose Level 1 (Starting Dose)Experimental350 mg/m2
Receives: Drug: Liposomal Curcumin (LipoCurc)
Dose Level 2Experimental400 mg/m2
Receives: Drug: Liposomal Curcumin (LipoCurc)
Dose Level 3Experimental450 mg/m2
Receives: Drug: Liposomal Curcumin (LipoCurc)
Dose Level 4Experimental500 mg/m2
Receives: Drug: Liposomal Curcumin (LipoCurc)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who experience Grade 4 neutropenia lasting more than 10 days despite use of growth factors

    Measured: 2 years

  2. Number of participants who experience Grade 3 or 4 Febrile neutropenia lasting more than 10 days

    Measured: 2 years

  3. Number of participants who experience Grade 3 thrombocytopenia with clinically significant bleeding or Grade 4 thrombocytopenia.

    Measured: 2 years

  4. Number of participants who experience Grade 3 anemia associated with clinically significant symptoms of hypoxia requiring red blood cell transfusion or Grade 4 anemia, unrelated to underlying disease.

    Measured: 2 years

  5. Number of participants who experience Grade 3 or 4 hemolysis requiring blood transfusion or medical intervention (eg. Steroids)

    Measured: 2 years

  6. Number of participants that experienced an adverse event.

    Measured: 2 years

Secondary outcomes (6)

  1. Proportion of patients who achieve a partial response (PR) or better (Overall Response Rate)

    Measured: 2 years

  2. Average time from first dose of study treatment to the first documentation of progressive disease or death from any cause (Progression Free Survival)

    Measured: 2 years

  3. Average time from the first partial response or better to the first documentation of progressive disease or death, whichever occurs earlier (Duration of Response)

    Measured: 2 years

  4. Average time from first dose of study treatment to the first documentation of partial response (PR) or better (Time to First Response)

    Measured: 2 years

  5. Average time from first dose of study treatment to the second consecutive documentation of the best response (Time to Best Response)

    Measured: 2 years

  6. Average time from first dose of study treatment to death from any cause (Overall Survival Rate)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study start27 Feb 2026
  3. Primary completion2 Mar 2028 (estimated)
  4. Study completion2 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Up to 4 dose levels will be tested: The starting dose of LipoCurc is 350mg/m2, Dose level 2 is 400 mg/m2, Dose level 3 is 450 mg/m2, and Dose level 4 is 500 mg/m2
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07456605
Sponsor's protocol ID
LipoCurc
Status last verified
Jun 2026
First submitted
2 Mar 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Liposomal Curcumin (LipoCurc) in people with Multiple Myeloma Refractory and Multiple Myeloma in Relapse, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guido Lancman, M.D. (416-946-2059, Guido.Lancman@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who experience Grade 4 neutropenia lasting more than 10 days despite use of growth factors (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07456605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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