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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib. Patients must have received at least two cycles of therapy. However, patients who have received high-dose therapy with melphalan as their only therapy are also eligible.

• Measurable hematologic disease: a dFLC \>20 mg/L with an abnormal κ/λ ratio (with Freelite® test kits, The Binding Site) or presence of a monoclonal spike ≥0.5 g/dL.

• Adequate bone marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:

• Absolute neutrophils ≥1,000/mm3,

• Platelets ≥75,000/mm3,

• Hemoglobin ≥8.5 g/dL.

• Adequate organ function, defined as:

• Serum creatinine clearance (CKD-EPI formula) ≥20 mL/min,

• Serum SGPT/ALT \<5.0 x Upper Limit of Normal (ULN),

• Serum total bilirubin \<2.0 mg/dL or direct bilirubin ≤30% of the total, unless the patient has Gilbert's syndrome, where direct bilirubin should then be \<2.0 mg/dL,

• Serum albumin ≥\<2.5 gr/dl (medication to correct serum albumin levels is permitted).

Locations
Other Locations
Australia
South Australia Health
NOT_YET_RECRUITING
Adelaide
Westmead Hospital
RECRUITING
Sydney
France
CHU Limoges
NOT_YET_RECRUITING
Limoges
Paris St Louis
NOT_YET_RECRUITING
Paris
Germany
University Hospital Essen
RECRUITING
Essen
University Hospital Heidelberg
RECRUITING
Heidelberg
University Hospital Würzburg
NOT_YET_RECRUITING
Würzburg
Greece
General Hospital of Athens Alexandra
RECRUITING
Athens
Italy
Fondazione I.R.C.C.S Policlinico San Matteo
NOT_YET_RECRUITING
Pavia
Netherlands
UMC Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Sarah Lonergan
sarah.lonergan@emn.org
+31 102687065
Backup
Emelie Asselbergs
emelie.asselbergs@emn.org
+31 102687065
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2028-09
Participants
Target number of participants: 30
Treatments
Experimental: Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Related Therapeutic Areas
Sponsors
Leads: European Myeloma Network B.V.
Collaborators: Janssen Research & Development

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.