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NCT06411301

A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors

Jules Bordet Institute·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Multiple Myeloma, Refractory,Multiple Myeloma in Relapse,Multiple Myeloma Progression
Drug/Device/Intervention
225Ac-DOTATATE
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Jules Bordet Institute
Location
Brussels, Belgium
Timeline & enrollment
Phase
Phase 1
Start date
Oct 01, 2024
End date
Oct 01, 2026
Enrollment
30 participants
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
Multiple myelomaMultiple myeloma and malignant plasma cell neoplasmsOsteoporosis in multiple myelomatosisChronic myeloproliferative diseaseMyelodysplastic and myeloproliferative disease, not elsewhere classified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06411301
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.