Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Arsenic, Cancer study, Failed treatment
Brief summary
The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma
Interventions
IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months
Sponsors
Alaunos Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03 | 6 months |
| Phase II efficacy using EMBT criteria. | 6 months |
| Safety | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of ZIO-101 | 6 months |
Countries
Canada, United States
Outcome results
None listed