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Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
Sponsor: Rajshekhar Chakraborty, MD
Summary
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.
Official title: An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2022-10-26
Completion Date
2026-09
Last Updated
2025-07-08
Healthy Volunteers
No
Conditions
Interventions
Venetoclax Oral Tablet, 200 mg
200 mg oral tablet daily
FISH assay
Cytogenetic analysis is intended for evaluation of relapsed/refractory AL amyloidosis using fluorescence in situ hybridization (FISH) using known translocation probes. Bone marrow aspirate (BMA) samples are collected in lavender top (Ethylenediaminetetraacetic acid (EDTA)) or green top (Sodium heparin) tubes. Specimen tubes shall be transported at room temperature to the laboratory on the same day of collection.
Venetoclax Oral Tablet, 400 mg
400 mg oral tablet daily
Dexamethasone Oral, 10 mg
10 mg oral tablet weekly
Dexamethasone Oral, 20 mg
20 mg oral tablet weekly
Daratumumab Injection
Daratumumab will be administered at a dose of 16 mg/kg by IV infusion once weekly for weeks 1 to 8, every 2 weeks for weeks 9 to 24, and every 4 weeks thereafter for a maximum of 6 months of therapy. If subcutaneous formulation is available, participants can also receive subcutaneous daratumumab (1800 mg in 15 ml) in the same schedule.
Bendamustine
Bendamustine will be given at an initial dose of 100 mg/m\^2 intravenously on days 1 and 2 in each 28-day cycle.
Pomalidomide
Pomalidomide will be administered at an initial dose of 2 mg per days on days 1-21 every 28 days.
Ixazomib
Ixazomib will be administered at an initial dose of 4 mg per days on days 1, 8, and 15 every 28 days.
Venetoclax MTD with Dexamethasone
Venetoclax MTD (200 mg or 400 mg) with Dexamethasone (10 mg or 20 mg) as determined by the phase I results
Locations (4)
Boston Medical Center
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States