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A Trial of a novel agent in participants with previously treated Immunoglobulin Light-Chain (AL) Amyloidosis
EU CTIS ID: 2024-519191-90-00
What this study is testing
To assess the hematologic CR rate after 3 cycles of single-agent teclistamab in patients with previously treated AL amyloidosis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Must have a 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.
- 2. 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.
- 3.Criterion modified per Amendment 1. 3.1 Age ≥18 years (and the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.
- 4. .Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 at screening and at C1D1 immediately prior to the start of administration of study treatment
- 5. Must have Mayo stage I–IIIA cardiac disease at Screening (see Appendix K for the definition of Mayo stages of cardiac disease).
- 6.Criterion modified per Amendment 1. 6.1 Patients must be relapsed and / or refractory and must have received at least 1 line of treatment, including Daratumumab/ Isatuximab/ other anti CD38 monoclonal antibodies and bortezomib either in the same regimen or in separate treatment lines administered sequentially. Patients must have received at least two cycles in the last line of therapy. Note: Refractory is defined as patients failing to achieve a VGPR with organ response in a regimen/line of therapy.
You likely can't join if
- 1. 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.
- 2. Isolated soft-tissue involvement.
- 3. Presence of non-AL amyloidosis.
- 4. Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).
- 5. Intolerance to dexamethasone that would prohibit treatment with trial therapy.
- 6. 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.
See the full eligibility criteria
Who can join
- 1. Must have a 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.
- 2. 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.
- 3.Criterion modified per Amendment 1. 3.1 Age ≥18 years (and the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent.
- 4. .Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 at screening and at C1D1 immediately prior to the start of administration of study treatment
- 5. Must have Mayo stage I–IIIA cardiac disease at Screening (see Appendix K for the definition of Mayo stages of cardiac disease).
- 6.Criterion modified per Amendment 1. 6.1 Patients must be relapsed and / or refractory and must have received at least 1 line of treatment, including Daratumumab/ Isatuximab/ other anti CD38 monoclonal antibodies and bortezomib either in the same regimen or in separate treatment lines administered sequentially. Patients must have received at least two cycles in the last line of therapy. Note: Refractory is defined as patients failing to achieve a VGPR with organ response in a regimen/line of therapy.
- 7.Criterion modified per Amendment 1. 7.1 Must have 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.
- 8. Criterion modified per Amendment 1.8.1 Must have at least one symptomatic organ involvement (heart, kidney, liver, lung, gastrointestinal [GI] tract or peripheral nervous system) at the time of AL-diagnosis (see Appendix B for the definition of symptomatic organ involvement).
- 9.Criterion modified per Amendment 1.9.1 A wash-out period of at least 14 days from the date of the last administration of any previous antitumor therapy or investigational treatment, meaning that the patient must not have received any non-Amyloidosis, anticancer therapy or investigational treatment for at least 14 days prior to Cycle 1 Day 1 (C1D1) of this trial and must have completed all previous treatment prior to screening.
What rules you out
- 1. 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.
- 2. Isolated soft-tissue involvement.
- 3. Presence of non-AL amyloidosis.
- 4. Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).
- 5. Intolerance to dexamethasone that would prohibit treatment with trial therapy.
- 6. 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.
- 7. 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.
- 8. Mayo stage IIIB cardiac disease at Screening (see Appendix K for the definition of Mayo stage IIIB of cardiac disease).
The study team makes the final eligibility decision.
Where it's taking place
- Australia
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia. 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 EU CTIS; the study team decides eligibility.