Study of the Safety and Usefulness of Liposomal Curcumin in Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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). OR Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).
Disqualifiers
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.
Adequately treated in situ carcinoma of the cervix uteri or the breast;
Trial design
Design model
Sequential
Treatments tested in this trial
Liposomal Curcumin (LipoCurc)
DrugLipoCurc 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.
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: Dose Level 1 (Starting Dose)Experimental treatment 1 intervention
Group B: Dose Level 2Experimental treatment 1 intervention
Group C: Dose Level 3Experimental treatment 1 intervention
Group D: Dose Level 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who experience Grade 4 neutropenia lasting more than 10 days despite use of growth factors
Time frame
2 years2
Number of participants who experience Grade 3 or 4 Febrile neutropenia lasting more than 10 days
Time frame
2 years3
Number of participants who experience Grade 3 thrombocytopenia with clinically significant bleeding or Grade 4 thrombocytopenia.
Time frame
2 years4
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.
Time frame
2 yearsSecondary outcomes
1
Proportion of patients who achieve a partial response (PR) or better (Overall Response Rate)
Time frame
2 years2
Average time from first dose of study treatment to the first documentation of progressive disease or death from any cause (Progression Free Survival)
Time frame
2 years3
Average time from the first partial response or better to the first documentation of progressive disease or death, whichever occurs earlier (Duration of Response)
Time frame
2 years4
Average time from first dose of study treatment to the first documentation of partial response (PR) or better (Time to First Response)
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov