NCT05451771Active, not recruitingPhase 1/2
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 53 (estimated)
- First submitted
- 6 Jul 2022
- Start date
- 26 Oct 2022
- Primary completion date
- Sept 2027
- Lead sponsor
- Columbia University
- Diseases
- Amyloidosis
- NCT number
- NCT05451771
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 53
- From 26 Oct 2022 to the primary completion date, Sept 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on renal replacement therapy
- Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors
Other illness
- Known hypersensitivity to any of the study drugs
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)
- Known GI disease or GI procedure that could interfere with oral absorption (including difficulty swallowing)
- New York Heart Association (NYHA) Class III or IV heart failure
- Patients with human immunodeficiency virus (HIV) who are not on highly active antiretroviral therapy (HAART) or those with active hepatitis A, B, or C infection
Age
- 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 the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment.)
Other
- Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide (NT-Pro BNP) \> 8500 pg/mL
- Patients meeting criteria for symptomatic multiple myeloma by one of the following:(a) Lytic lesions on imaging (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, or (c) Bone marrow plasma cell infiltrate of greater than 60%
Who the study is looking for
- Age ≥ 18 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Confirmed diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) on a tissue biopsy
- Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation 38 (CD 38) monoclonal antibody
- Participants with a history of autologous hematopoietic cell transplantation must have recovered from any transplant-related toxicities
- Presence of t(11;14) on FISH at any time since diagnosis (Eligibility must confirmed by FISH testing at Columbia University Irving Medical Center (CUIMC)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Froedtert Hospital & the Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| New York Presbyterian Hospital/Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.