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NCT05451771

Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Columbia University
~53 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Venetoclax Oral Tablet, 200 mgFISH assayVenetoclax Oral Tablet, 400 mgDexamethasone Oral, 10 mgDexamethasone Oral, 20 mgDaratumumab Injection

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose Limiting Toxicities (DLT) (Phase 1)
Measured over Up to 6 cycles (approximately 6 months)
+1 more outcome measured

Conditions

AL Amyloidosis

Explore related trials

Primary Amyloidosist(11;14)

Where it's being run

5 sites across 5 states
Massachusetts1
Minnesota1
Missouri1
New York1
Wisconsin1

Study leadership

  • Rajshekhar Chakraborty, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Known hypersensitivity to any of the study drugs
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.)
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
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
Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide (NT-Pro BNP) \> 8500 pg/mL
Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors
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
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%

What this trial measures

  • Number of Participants with Dose Limiting Toxicities (DLT) (Phase 1)Up to 6 cycles (approximately 6 months)

    The number of participants with dose limiting toxicities for each treatment dose will be used to determine the MTD. Dose limiting toxicity defined as grade 4 neutropenia lasting more than 5 days, any grade febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with bleeding, other therapy related non-hematologic toxicity of grade 2 or higher that requires discontinuation of therapy, clinical tumor lysis syndrome (TLS), laboratory TLS if the metabolic abnormalities are considered clinically significant by the investigator. All other grade 3 or higher adverse events (AEs) will be considered as DLTs with a few exceptions.

  • Hematologic ≥ Very Good Partial Response (VGPR) Rate (Phase 2)Up to 6 cycles (approximately 6 months)

    Hematologic ≥VGPR rate defined as proportion of participants achieving VGPR, low serum differential free light chain concentration (dFLC) partial response (PR), or a complete (CR). VGPR is defined as the difference between involved and uninvolved free light chain (FLC) \[dFLC\] \< 40 mg/L. Low dFLC PR is defined as achieving a dFLC\<10 mg/L, low dFLC PR will be considered as a deep hematologic response and included in the ≥VGPR category). CR is defined as negative serum and urine immunofixation electrophoresis along with a serum free light chain ratio that lies within the normal range or skewed towards the non-amyloid forming light chain, as per institutional laboratory values