Trial Title:
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
NCT ID:
NCT06649695
Condition:
AL Amyloidosis
Conditions: Official terms:
Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Conditions: Keywords:
teclistamab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Teclistamab
Description:
Teclistamab will be administered via a subcutaneous injection (SC)
Arm group label:
Teclistamab
Other name:
JNJ-64007957
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
- Intolerance to dexamethasone that would prohibit treatment with trial therapy.
- MM diagnosed as per the International Myeloma Working Group (IMWG) criteria, with
the exception of monoclonal gammopathy of unknown significance (MGUS) or smoldering
Myeloma, not requiring treatment.
Note: A MM diagnosis with a serum FLC ratio >100, as the only myeloma-defining event,
does NOT constitute an exclusion.
- All hematologic malignancies, with the exception of low-risk Philadelphia chromosome
negative (Ph-) myeloproliferative neoplasms (MPNs) and low-risk myelodysplastic
syndromes (MDS), not requiring treatment.
- Mayo stage IIIB cardiac disease at Screening
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
South Australia Health
Address:
City:
Adelaide
Country:
Australia
Contact:
Last name:
Horvath
Facility:
Name:
Westmead Hospital
Address:
City:
Sydney
Country:
Australia
Contact:
Last name:
Kwok
Facility:
Name:
CHU Limoges
Address:
City:
Limoges
Country:
France
Contact:
Last name:
Roussel
Facility:
Name:
Paris St Louis
Address:
City:
Paris
Country:
France
Contact:
Last name:
Arnulf
Facility:
Name:
University Hospital Essen
Address:
City:
Essen
Country:
Germany
Contact:
Last name:
Carpinteiro
Facility:
Name:
University Hospital Heidelberg
Address:
City:
Heidelberg
Country:
Germany
Contact:
Last name:
Schönland
Facility:
Name:
University Hospital Würzburg
Address:
City:
Würzburg
Country:
Germany
Contact:
Last name:
Kortüm
Facility:
Name:
General Hospital of Athens "Alexandra"
Address:
City:
Athens
Country:
Greece
Contact:
Last name:
Kastritis
Facility:
Name:
Fondazione I.R.C.C.S Policlinico "San Matteo"
Address:
City:
Pavia
Country:
Italy
Contact:
Last name:
Palladini
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Country:
Netherlands
Contact:
Last name:
Minnema
Start date:
March 2025
Completion date:
September 2028
Lead sponsor:
Agency:
European Myeloma Network B.V.
Agency class:
Other
Collaborator:
Agency:
Janssen Research & Development
Agency class:
Other
Source:
European Myeloma Network B.V.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06649695
