Liposomal Curcumin for Multiple Myeloma

Overseen By Guido Lancman, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University Health Network, Toronto

Must not be taking: Immunosuppressants, Anticancer agents

Disqualifiers: Amyloidosis, Cardiovascular risk, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment, Liposomal Curcumin (LipoCurc), for individuals with multiple myeloma, a type of blood cancer that has recurred or stopped responding to treatment. Researchers aim to identify the highest dose that can be administered without causing very severe side effects. Participants will begin with lower doses, and new participants may receive higher doses if side effects remain manageable. This trial may suit those who have tried other standard treatments for multiple myeloma without success, particularly if their condition is worsening. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that Liposomal Curcumin (LipoCurc) is likely to be safe for humans?

Research has shown that liposomal curcumin (LipoCurc) underwent safety testing in earlier studies. One study found that 300 mg/m² was the highest dose patients could tolerate without serious side effects. Researchers used this dose as a starting point for further cancer treatment research.

Patients generally tolerated liposomal curcumin well, although temporary changes in red blood cells occurred. These changes did not lead to major health problems. Additionally, curcumin has shown promise in slowing the growth of myeloma cells, which are linked to multiple myeloma.

The trial under consideration is in its early stages, focusing primarily on identifying the safest dose for humans without causing serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Unlike the standard treatments for multiple myeloma, which typically include chemotherapy, targeted therapy, and stem cell transplants, Liposomal Curcumin (LipoCurc) offers a novel approach. LipoCurc is derived from curcumin, the active ingredient in turmeric, known for its anti-inflammatory properties. This treatment is unique because it uses a liposomal delivery system, which enhances the absorption and bioavailability of curcumin, potentially increasing its effectiveness against cancer cells. Researchers are excited about LipoCurc because it could offer a less toxic alternative with fewer side effects compared to traditional chemotherapy, while still effectively targeting multiple myeloma cells.

What evidence suggests that Liposomal Curcumin might be an effective treatment for Multiple Myeloma?

Research suggests that liposomal curcumin (LipoCurc) could aid in treating multiple myeloma, a type of blood cancer. Studies have shown that curcumin can reduce the survival of myeloma cells and initiate apoptosis, a natural process that removes cancer cells. In lab tests, myeloma cells absorbed LipoCurc well, indicating effective targeting of these cancer cells. Additionally, past research has demonstrated that curcumin can improve remission rates in myeloma patients due to its anti-inflammatory effects. These findings suggest that LipoCurc might effectively combat multiple myeloma, but more human studies are needed to confirm these results. Participants in this trial will receive different dosages of LipoCurc to evaluate its safety and effectiveness. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have had an autologous stem cell transplant and meet the study's other requirements.

I am able to care for myself and do daily activities.

I am 18 years old or older.

Exclusion Criteria

Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study procedures

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to liposomal curcumin

I have a history of active amyloidosis, POEMS syndrome, or plasma cell leukemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Treatment

Participants receive escalating doses of Liposomal Curcumin to determine the maximum tolerated dose

8-12 weeks

Weekly visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liposomal Curcumin (LipoCurc)

How Is the Trial Designed?

Group I: Dose Level 4 Experimental Treatment 1 Intervention

500 mg/m2

Group II: Dose Level 3 Experimental Treatment 1 Intervention

450 mg/m2

Group III: Dose Level 2 Experimental Treatment 1 Intervention

400 mg/m2

Group IV: Dose Level 1 (Starting Dose) Experimental Treatment 1 Intervention

350 mg/m2

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07456605

Study of the Safety and Usefulness of Liposomal Curcumin ...

Curcumin has been shown in the laboratory to have antioxidant (may help prevent damage to cells),anti-inflammatory (may help reduce swelling, ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30842145/

Intense Uptake of Liposomal Curcumin by Multiple ...

Results: Extremely intense uptake was seen in both MM lines compared to that in B-lymphocytes and previously published data in RBCs, PBMCs and CLL cells.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9301229/

Curcumin as adjuvant therapy to improve remission in ... - PMC

The primary outcome of this study was to prove the efficacy of curcumin in the improvement of the remission in myeloma patients. The secondary outcome was to ...

4.

biospace.com

biospace.com/multiple-myeloma-causing-plasma-cells-show-intense-uptake-of-intravenous-liposomal-curcumin-as-reported-by-signpath-pharma-inc-in-paper-published-in-the-cancer-research-journal-anticancer-research

Multiple Myeloma-Causing Plasma Cells Show Intense ...

SignPath is planning several phase 2 trials to test the efficacy of LipoCurc™ against specific cancer types, including against multiple myeloma.

5.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1589090/full

Multiple myeloma inhibitory effects of natural compounds

A randomized controlled trial in 2022 supports CUR's anti-inflammatory mechanism with a significant remission rate of 75% compared to 33% in the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6132848/

A phase 1 dose-escalation study on the safety, tolerability and ...

300 mg/m2 liposomal curcumin over 6 h was the maximum tolerated dose in these heavily pretreated patients, and is the recommended starting dose for anti-cancer ...

7.

ar.iiarjournals.org

ar.iiarjournals.org/content/39/3/1161

Intense Uptake of Liposomal Curcumin by Multiple ...

The goal of this study was to investigate the disposition of curcumin in the form of Lipocurc™ in multiple myeloma (MM)-causing plasma cell lines and B- ...

8.

delta.larvol.com

delta.larvol.com/Products/?ProductId=888d93bc-579a-4f90-9da2-da97aaa44270

LipoCurc (liposomal curcumin) / Signpath Pharma

Study of the Safety and Usefulness of Liposomal Curcumin in Multiple Myeloma (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: University ...