A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors - Trial NCT06411301
Access comprehensive clinical trial information for NCT06411301 through Pure Global AI's free database. This Phase 1 trial is sponsored by Jules Bordet Institute and is currently Not yet recruiting. The study focuses on Multiple Myeloma, Refractory,Multiple Myeloma in Relapse,Multiple Myeloma Progression. Target enrollment is 30 participants.
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Study Focus
225Ac-DOTATATE
Interventional
drug
Sponsor & Location
Jules Bordet Institute
Timeline & Enrollment
Phase 1
Oct 01, 2024
Oct 01, 2026
Primary Outcome
Safety and tolerability of 225Ac-DOTATATE,Recommended phase II dose of 225Ac-DOTATATE
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) PET/CT. The response to 225Ac-DOTATATE
 therapy will also be assessed in the target study population.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06411301
Non-Device Trial