Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411301
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors
Sponsor:
Jules Bordet Institute
Organization:
Jules Bordet Institute
Study Overview
Official Title:
A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AcTRESS
Brief Summary:
This study aims to determine the safety and the recommended phase II dose of RYZ101 actinium-225 labelled DOTA-octreotate 225Ac-DOTATATE in participants with refractory and relapsing multiple myeloma MM that have received at least 3 prior lines of myeloma therapy Participants will be selected based on somatostatin receptor SSTR positivity assessed by gallium-68 labelled DOTA-octreotate 68Ga-DOTATATE PETCT The response to 225Ac-DOTATATE therapy will also be assessed in the target study population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None