A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis

ConditionAL Amyloidosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorEuropean Myeloma Network B.V.

About this trial

This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic diagnosis of AL amyloidosis and typed with immunohistochemistry/ immunofluorescence, immunoelectron microscopy, or mass spectrometry. In patients with biopsy-confirmed amyloidosis, ambiguous amyloid typing results, and cardiac involvement alone, a negative pyrophosphate (PYP) or technetium-99m (99mTc) and 3,3-diphosphono-1,2-propanodicarboxylic acid (DPD-Tc99m) bone scan is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.

Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry/ immunofluorescence/ immunoelectron microscopy/ mass spectrometry of amyloid deposits must provide clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement. Data from the initial diagnosis are accepted.

Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2

Mayo stage I-IIIA cardiac disease at Screening

Disqualifiers

Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.

Isolated soft-tissue involvement.

Presence of non-AL amyloidosis.

Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).

Trial design

Design model

Single group

Treatments tested in this trial

Teclistamab
Drug
Teclistamab will be administered via a subcutaneous injection (SC)

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: TeclistamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Hematologic Complete Response (CR) rate

Percentage of participants achieving CR or better according to EHA/ISA guidelines

Time frame

baseline up to 3 cycles of treatment (approximately 3 months)

Secondary outcomes

Hematologic Overall Response Rate (ORR) rate

Percentage of participants achieving Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) or better according to EHA/ISA guidelines

Time frame

Baseline up to progression of disease or death (approximately 3,5 years)