Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616389
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Study of ODX OsteoDex in Multiple Myeloma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIa Study of ODX OsteoDex in Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current phase IIIa trial is a multi-center prospective open-label ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX Each dose cohort will consist of 4 subjects Each subject will receive up to 7 doses of ODX given at 2-week intervals until unacceptable toxicity or disease progression A follow-up visit will be conducted 2 weeks after the last dose
Primary objectives
To determine the safety and tolerability of ODX in subjects with relapsedrefractory multiple myeloma
Secondary objectives
To evaluate the preliminary efficacy of ODX as determined by the IMWG response criteria in subjects with relapsedrefractory multiple myeloma
To evaluate the efficacy of ODX on serum biomarkers M-protein FLC CTX osteocalcin and bone-specific S-ALP in subjects with relapsedrefractory multiple myeloma
Exploratory objective
To evaluate time to progression by following M-protein and FLC levels as per clinical routine
Primary objectives
To determine the safety and tolerability of ODX in subjects with relapsedrefractory multiple myeloma
Secondary objectives
To evaluate the preliminary efficacy of ODX as determined by the IMWG response criteria in subjects with relapsedrefractory multiple myeloma
To evaluate the efficacy of ODX on serum biomarkers M-protein FLC CTX osteocalcin and bone-specific S-ALP in subjects with relapsedrefractory multiple myeloma
Exploratory objective
To evaluate time to progression by following M-protein and FLC levels as per clinical routine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None