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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Rajshekhar Chakraborty, MD
Study ID
NCT05451771
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • AL Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax Oral Tablet, 200 mg — DRUG
    200 mg oral tablet daily
  • FISH assay — DEVICE
    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 — DRUG
    400 mg oral tablet daily
  • Dexamethasone Oral, 10 mg — DRUG
    10 mg oral tablet weekly
  • Dexamethasone Oral, 20 mg — DRUG
    20 mg oral tablet weekly
  • Daratumumab Injection — DRUG
    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 — DRUG
    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 — DRUG
    Pomalidomide will be administered at an initial dose of 2 mg per days on days 1-21 every 28 days.
  • Ixazomib — DRUG
    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 — DRUG
    Venetoclax MTD (200 mg or 400 mg) with Dexamethasone (10 mg or 20 mg) as determined by the phase I results

Study Details

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.

Key Dates

Start date
Oct 26, 2022
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
53 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Venetoclax 200 mg
    Cohort 1: Venetoclax 200 mg tablet, once daily for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
  • Experimental: Phase 1: Venetoclax 400mg
    Cohort 2: Venetoclax 400 mg tablet, once daily for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
  • Experimental: Phase 1: Venetoclax 400mg + Dexamethasone 10 mg
    Cohort 3: Venetoclax 400 mg tablet, once daily and Dexamethasone 10 mg tablet once weekly, for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
  • Experimental: Phase 1: Venetoclax 400mg + Dexamethasone 20 mg
    Cohort 4: Venetoclax 400 mg tablet, once daily and Dexamethasone 20 mg tablet once weekly, for up to 2 cycles after achieving best response, for a maximum of 6 cycles (1 cycle = 28 days)
  • Experimental: Phase 2: 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
  • Active Comparator: Phase 2: Control Arm (Investigator's Choice)
    Participants will receive one of the following as determined by the investigator: Daratumumab, Pomalidomide, Bendamustine, or Ixazomib (+/- dexamethasone)

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities (DLT) (Phase 1) [ Time Frame: Up to 6 cycles (approximately 6 months) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Boston Medical Center
617-638-8265
Vaishali Sanchorawala, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Mayo Clinic Rochester
8557760015
Prashant Kapoor, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital/Columbia University Irving Medical CenterNew YorkNew York10032
Research Nurse Navigator
[email protected]
212-342-5162
Rajshekhar Chakraborty, MD (PRINCIPAL_INVESTIGATOR)
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Froedtert Hospital & the Medical College of Wisconsin
[email protected]
414-805-8900
Anita D'Souza, MD (PRINCIPAL_INVESTIGATOR)

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