A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophos… (NCT07224672) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis
60 participantsStarted 2026-03-20
Plain-language summary
The study aims to evaluate the efficacy and safety of belantamab mafodotin in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed (ND) AL amyloidosis .
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* Participant is at least 18 years of age or the legal age of consent
* Has histologically confirmed newly diagnosed primary AL amyloidosis according to the following criteria:
* Presence of an amyloid-related systemic syndrome as per consensus guidelines.
* Positive amyloid staining by Congo red stain with green birefringence on polarized light microscopy in any tissue AND at least 1 of the following tests to confirm amyloid type as AL Characteristic appearance by electron microscopy or confirmatory immunohistochemistry or AL amyloidosis typing by mass spectrometric proteomic analysis of the amyloid deposits or amyloid-typing by immunofluorescence oEvidence of a monoclonal plasma cell proliferative disorder
* Measurable clonal disease as defined by at least 1 of the following:
* Serum monoclonal protein \>=0.5 grams per deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation performed at central laboratory),
* Involved serum FLC \>=5.0 milligram per deciliter (mg/dL) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved light chain, FLC concentrations (dFLC) \>=5 mg/dL.
* Not considered candidate for high-dose chemotherapy with autologous stem cell transplantation (ASCT) as part of first line of therapy
* Is willing to use adequate contraception.
* Is capable of giving signed informed consent
* Has an Eastern Cooperative Oncology Group performance status of 0, 1 or 2
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