CompletedPhase 2

A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL Amyloidosis

France, Germany, Greece35 participantsStarted 2021-02-26

Plain-language summary

This is an open-label, multicenter, Phase 2 study in subjects with previously treated patients with light chain (AL) amyloidosis in need for therapy. Approximately 35 subjects will receive therapy with belantamab mafodotin. Subject participation will include a Screening Phase, a Treatment Phase, a Post-Treatment Observation Phase, and a Long-term Follow-up Phase. A safety run-in will be conducted in 6 subjects treated with belantamab mafodotin for at least 1 cycle. According to the two-stage statistical design of the study, an interim analysis of efficacy will occur. If after 15 patients have been enrolled at least 3 complete or very good partial responses have been recorded, the accrual will continue until all planned patients have been enrolled

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry or if not available, for patients with biopsy confirmed amyloidosis and cardiac involvement alone, if they also have a negative PYP- or DPD-Tc99m bone scan.
✓. Previous systemic therapy for AL amyloidosis
✓. Patients must be ≥ 18 years of age.
✓. ECOG performance status 0, 1 or 2.
✓. Mayo stage 1 or Mayo stage 2 or Mayo stage 3A1-3 defined as both cTnT \< 0.035 ng/mL (or in place of cTnT the cTnI \< 0.10 ng/mL or high sensitivity Troponin T \< 54 ng/L) AND simultaneous NT-proBNP ≤ 332 ng/L, OR EITHER above threshold, or BOTH above threshold but with NTproBNP \< 8500 ng/L (stage 3A disease)
✓. Supine systolic blood pressure ≥ 90 mmHg
✓. Measurable disease defined by at least one of the following:
✓. serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L).

Exclusion criteria

What they're measuring

response rate

Timeframe: at 6 months (cycle 4)

Trial details

NCT IDNCT04617925

SponsorStichting European Myeloma Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-07-17

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