NCT06411301

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma, Refractory
• Multiple Myeloma in Relapse
• Multiple Myeloma Progression

Interventions

Type	Name	Description
DRUG	225Ac-DOTATATE	Two intravenous infusions every 6 weeks (Q6W)

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-05-13
• Last updated: 2025-01-31

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study