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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06649695




Registration number
NCT06649695
Ethics application status
Date submitted
18/10/2024
Date registered
21/10/2024
Date last updated
21/10/2024

Titles & IDs
Public title
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
Scientific title
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
Secondary ID [1] 0 0
EMN40/64007957AMY2002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AL Amyloidosis 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Teclistamab

Experimental: Teclistamab - Teclistamab will be administered via a subcutaneous injection (SC)


Treatment: Drugs: Teclistamab
Teclistamab will be administered via a subcutaneous injection (SC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hematologic Complete Response (CR) rate
Timepoint [1] 0 0
baseline up to 3 cycles of treatment (approximately 3 months)
Secondary outcome [1] 0 0
Hematologic Overall Response Rate (ORR) rate
Timepoint [1] 0 0
Baseline up to progression of disease or death (approximately 3,5 years)

Eligibility
Key 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 ? or ? 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 ?/? 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
South Australia Health - Adelaide
Recruitment hospital [2] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Limoges
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
Germany
State/province [3] 0 0
Essen
Country [4] 0 0
Germany
State/province [4] 0 0
Heidelberg
Country [5] 0 0
Germany
State/province [5] 0 0
Würzburg
Country [6] 0 0
Greece
State/province [6] 0 0
Athens
Country [7] 0 0
Italy
State/province [7] 0 0
Pavia
Country [8] 0 0
Netherlands
State/province [8] 0 0
Utrecht

Funding & Sponsors
Primary sponsor type
Other
Name
European Myeloma Network B.V.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Janssen Research & Development
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/study/NCT06649695
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Murielle Roussel, MD
Address 0 0
CHU Limoges
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Lonergan
Address 0 0
Country 0 0
Phone 0 0
+31 102687065
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06649695