OncoMatch/Clinical Trials/NCT05363111
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
Is NCT05363111 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Actinium Ac 225-DOTA-Daratumumab and Daratumumab for recurrent plasma cell myeloma.
Treatment: Actinium Ac 225-DOTA-Daratumumab · Daratumumab · Indium In 111-DOTA-Daratumumab — This phase I trial tests the safety, side effects, and best dose of actinium Ac 225-DOTA-daratumumab (225Ac-DOTA-daratumumab) in combination with daratumumab and indium In 111-DOTA-daratumumab (111In-DOTA-daratumumab) in treating patients with multiple myeloma that does not respond to treatment (refractory) or that has come back (recurrent). Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab are forms of radioimmunotherapy in which a monoclonal antibody, daratumumab, has been linked to a radiotracer to allow for targeted delivery of the treatment to cancer cells. Giving all three together may kill more cancer cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: CD38 expression (positive)
Performance status
KARNOFSKY 60–100
Karnofsky performance status (KPS) > 60%
Prior therapy
Must have received: proteasome inhibitor
Previously received treatment with all of the following: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody
Must have received: immunomodulatory drug
Previously received treatment with all of the following: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody
Must have received: anti-CD38 monoclonal antibody (daratumumab)
Refractory (defined per IMWG Consensus Criteria) to daratumumab
Cannot have received: radiopharmaceutical therapy
Prior radiopharmaceutical therapy
Cannot have received: anti-CD38 antibody (daratumumab)
Exception: if < 3 months prior to study enrollment
Daratumumab or other anti CD38 antibody treatment < 3 months prior to study enrollment
Cannot have received: radiation therapy
Exception: if > 25% of bone marrow
Subject has received previous radiation to > 25% of their bone marrow
Lab requirements
Blood counts
ANC >= 1,000/mm^3 (within 14 days prior to day 1 of protocol therapy); Platelets >= 75,000/mm^3 (>= 50,000/mm^3 if >= 50% marrow involvement)
Kidney function
Creatinine <= 1.5 mg/dl AND/OR creatinine clearance of >= 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 x ULN (unless has Gilbert's disease); AST <= 3 x ULN; ALT <= 3 x ULN
ANC >= 1,000/mm^3; Platelets >= 75,000/mm^3 (>= 50,000/mm^3 if >= 50% marrow involvement); Total bilirubin <= 1.5 x ULN (unless has Gilbert's disease); AST <= 3 x ULN; ALT <= 3 x ULN; Creatinine <= 1.5 mg/dl AND/OR creatinine clearance of >= 40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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