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New treatment option for Amyloid Light-chain Amyloidosis
Official title Teclistamab-Daratumumab in AL Amyloidosis
ClinicalTrials.gov ID: NCT07110844
What this study is testing
What is Teclistamab?
Teclistamab is an investigational medicine, being studied as a potential treatment for amyloid light-chain amyloidosis.
Also referred to as TECVAYLI, teclistamab-cqyv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Age \>18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide...
- Ability to comply with the study protocol, in the investigator's judgment.
- Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a...
- Patient must not have received any prior plasma cell clone-directed therapy.
- Measurable hematologic disease, defined as one of the following:
You likely can't join if
- Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior...
- Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT...
- Evidence of significant cardiovascular conditions as specified below:
- NT-Pro BNP \> 8500 pg/mL, and/or
- NYHA Class IIIb or IV functional class
- History of other malignancy that could affect compliance with the protocol or interpretation of results. Patients with a history of curatively...
See the full eligibility criteria
- Age \>18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a...
- Ability to comply with the study protocol, in the investigator's judgment.
- Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red.
- Patient must not have received any prior plasma cell clone-directed therapy.
- Measurable hematologic disease, defined as one of the following:
- Difference between involved and uninvolved serum free light chain (dFLC) ≥50 mg/L and/or 5 mg/dL
- Serum M-protein ≥0.5 g/dL on protein electrophoresis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- One or more organs involved by AL amyloidosis as per consensus guidelines
- Pre-treatment clinical laboratory values meeting the following criteria during the screening phase:
- Absolute neutrophil count ≥0.75 × 10\^9/L
- Hemoglobin level ≥8.0 g/dL; red blood cell transfusion allowed until 7 days before C1D0.
- Platelet count ≥50 × 10\^9/L; Platelet transfusions are acceptable without restriction during the Screening period
- Alanine aminotransferase level (ALT) ≤2.5 times the Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) ≤2.5 times the ULN
- Total bilirubin level ≤1.5 × ULN except for people with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN
- Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m\^2, measured by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs. For men: Agreement to remain abstinent...
- Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0.
- Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT or MRI, or PET/CT) (b) Plasmacytoma, (c) Hypercalcemia without any...
- Evidence of significant cardiovascular conditions as specified below:
- NT-Pro BNP \> 8500 pg/mL, and/or
- NYHA Class IIIb or IV functional class
- History of other malignancy that could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of...
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal).
- Patients on renal replacement therapy
- Patients with HIV who are not on HAART or those with active hepatitis A, B, or C infection.
- Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted, as per investigators' discretion.
- Known hypersensitivity to any of the agents
- Patients who are receiving any other investigational agent concurrently.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.