OncoMatch/Clinical Trials/NCT05055063
A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
Is NCT05055063 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Belantamab mafodotin for myeloma.
Treatment: Belantamab mafodotin — This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficacy will be assessed through the overall response rate (ORR) at the end of the study. With the limited number of patients for the dose-expansion part, we will not have formal futility monitoring rule.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy agents approved for the treatment of smoldering multiple myeloma
Exception: Patients who have been treated previously on a clinical trial or with non-approved agents for their smoldering myeloma can be included.
not have received prior or concurrent treatment for smoldering multiple myeloma with chemotherapy agents approved for the treatment of smoldering multiple myeloma
Cannot have received: radiation therapy
Radiotherapy is not permitted.
Cannot have received: corticosteroids
Exception: unless the patient is on a stable chronic dose of inhaled steroids to treat respiratory diseases or on stable chronic steroid replacement therapy for endocrinology disorders. Steroids may be used to treat infusion related reactions. Inhaled, intranasal, and topical ophthalmic steroids are not prohibited.
Treatment with corticosteroids is not permitted, unless the patient is on a stable chronic dose of inhaled steroids to treat respiratory diseases or on stable chronic steroid replacement therapy for endocrinology disorders. Steroids may be used treat infusion related reactions. Inhaled, intranasal, and topical ophthalmic steroids are not prohibited.
Cannot have received: monoclonal antibody
Received prior treatment with a monoclonal antibody within 30 days of receiving the first dose of belantamab mafodotin
Cannot have received: other anti-cancer therapy
Concurrent treatment with other anti-cancer therapy is not permitted
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 /L, hemoglobin more or equal than 2 grams below the institutional level of normal and platelet count ≥ 90 x 10^9/L. Platelet and blood transfusions are allowed on protocol.
Kidney function
Creatinine clearance (CrCl) ≥ 30 ml/min. CrCl will be calculated using the Modification of Diet in Renal Disease (MDRD) equation.
Liver function
bilirubin ≤ 1.5 x the ULN, and AST and ALT ≤ 2.5 x ULN
Creatinine clearance (CrCl) ≥ 30 ml/min... Adequate hepatic function, with bilirubin ≤ 1.5 x the ULN, and AST and ALT ≤ 2.5 x ULN. Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 /L, hemoglobin more or equal than 2 grams below the institutional level of normal and platelet count ≥ 90 x 10^9/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify