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

NCT07456605 | Recruiting Phase 1 DMC

• 1 other identifier: LipoCurc
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Myeloma Refractory; Multiple Myeloma in Relapse

Keywords

Liposomal Curcumin

Outcome Measures

Primary Outcomes (6)

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

  2 years

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

  2 years

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

  2 years

• 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.

  2 years

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

  2 years

• Number of participants that experienced an adverse event.

  2 years

Secondary Outcomes (6)

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

  2 years

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

  2 years

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

  2 years

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

  2 years

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

  2 years

Study Arms (4)

Dose Level 1 (Starting Dose)

EXPERIMENTAL

350 mg/m2

Drug: Liposomal Curcumin (LipoCurc)

Dose Level 2

EXPERIMENTAL

400 mg/m2

Drug: Liposomal Curcumin (LipoCurc)

Dose Level 3

EXPERIMENTAL

450 mg/m2

Drug: Liposomal Curcumin (LipoCurc)

Dose Level 4

EXPERIMENTAL

500 mg/m2

Drug: Liposomal Curcumin (LipoCurc)

Interventions

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.

Dose Level 1 (Starting Dose); Dose Level 2; Dose Level 3; Dose Level 4

Eligibility Criteria

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

You may qualify 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., 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.
• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network-Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Central Study Contacts

Guido Lancman, M.D.

CONTACT

416-946-2059; Guido.Lancman@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): March 2, 2028
• Study Completion (Estimated): March 2, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)