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

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.

Conditions

• AL Amyloidosis

Interventions

DRUG

Venetoclax Oral Tablet, 200 mg

200 mg oral tablet daily

DEVICE

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.

DRUG

Venetoclax Oral Tablet, 400 mg

400 mg oral tablet daily

DRUG

Dexamethasone Oral, 10 mg

10 mg oral tablet weekly

DRUG

Dexamethasone Oral, 20 mg

20 mg oral tablet weekly

DRUG

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.

DRUG

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.

DRUG

Pomalidomide

Pomalidomide will be administered at an initial dose of 2 mg per days on days 1-21 every 28 days.

DRUG

Ixazomib

Ixazomib will be administered at an initial dose of 4 mg per days on days 1, 8, and 15 every 28 days.

DRUG

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

Sponsors & Collaborators

• Genentech, Inc.

  collaborator INDUSTRY

• Rajshekhar Chakraborty, MD

  lead OTHER

Principal Investigators

• Rajshekhar Chakraborty, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-26

Primary Completion

2026-09-30

Completion

2026-09-30

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations