Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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
Eligibility criteria
Qualifiers
Must have received a proteosome inhibitor, alkylator and anti-cluster of differentiation 38 (CD38) antibody (e.g., daratumumab - for patients who were eligible to receive in newly diagnosed AL Amyloidosis) and autologous stem cell transplant (for transplant eligible candidates).
Failed treatment and/or intolerant/ineligible for above agents
Participant must be over 18 years of age inclusive, at the time of signing the informed consent.
Participant and Disease Characteristics: Patient must have primary systemic AL amyloidosis, histologically confirmed at the initial diagnosis before initiation of 1st-line treatment by positive Congo red stain with green birefringence on polarized light microscopy, Or characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence).
Disqualifiers
Patients previously treated for active symptomatic multiple myeloma.
Any corneal disease except for mild epithelial punctate keratopathy.
Patients with known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
Patients eligible for autologous stem cell transplantation (ASCT).
Trial design
Treatments tested in this trial
- 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)
Treatment groups
37 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Texas Southwestern Medical Center
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov