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
Qualifiers
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
Treatments tested in this trial
- Liposomal Curcumin (LipoCurc)
Treatment groups
20 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov