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Study of ZIO-101 in Multiple Myeloma

A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00303199
Enrollment
35
Registered
2006-03-15
Start date
2006-01-31
Completion date
2007-08-31
Last updated
2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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
Lead SponsorINDUSTRY

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

MeasureTime frame
Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/036 months
Phase II efficacy using EMBT criteria.6 months
Safety6 months

Secondary

MeasureTime frame
Pharmacokinetics of ZIO-1016 months

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026