OncoMatch/Clinical Trials/NCT05145816
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Is NCT05145816 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for al amyloidosis.
Treatment: Belantamab mafodotin 2.5 mg/kg (8 weeks) · Belantamab mafodotin 1.9 mg/kg (8 weeks) · Belantamab mafodotin 1.4 mg/kg (12 weeks) · Belantamab mafodotin 1.9 mg/kg (12 weeks) · Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages · Belantamab mafodotin 1.0 mg/kg (12 weeks) — The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug. The study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
Must have received a proteosome inhibitor
Must have received: alkylating agent
Must have received an alkylator
Must have received: anti-CD38 antibody (daratumumab) — for patients who were eligible to receive in newly diagnosed AL Amyloidosis
Must have received anti-cluster of differentiation 38 (CD38) antibody (e.g., daratumumab - for patients who were eligible to receive in newly diagnosed AL Amyloidosis)
Must have received: autologous stem cell transplant — for transplant eligible candidates
autologous stem cell transplant (for transplant eligible candidates)
Cannot have received: treatment for active symptomatic multiple myeloma
Patients previously treated for active symptomatic multiple myeloma
Lab requirements
Blood counts
ANC: ≥1.0 × 10^9/L; Hemoglobin: ≥8.0 g/dL; Platelets: ≥50 × 10^9/L (without growth factor or cell transfusion support for the past 14 days prior to testing, excluding erythropoietin)
Kidney function
Estimated glomerular rate (eGFR): ≥30 mL/min/1.73 m2 (MDRD formula)
Liver function
Total bilirubin: ≤1.5 × ULN (Isolated bilirubin ≥1.5 × ULN is acceptable if bilirubin is fractionated, and direct bilirubin is <35%); ALT: ≤2.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) > 35% within 28 days prior to registration
Adequate organ system functions within 14 days of registration as defined by the laboratory assessments below: Hematologic...Hepatic...Renal...Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) > 35% within 28 days prior to registration.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Vanderbilt Ingram Cancer Center · Nashville, Tennessee
- UT Southwestern Medical Center · Dallas, Texas
- Huntsman Cancer Institute, University of Utah · Salt Lake City, Utah
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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