Actively Recruiting
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
Led by Rajshekhar Chakraborty, MD · Updated on 2025-07-08
53
Participants Needed
4
Research Sites
200 weeks
Total Duration
On this page
Sponsors
R
Rajshekhar Chakraborty, MD
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Ability to comply with study protocol as judged by investigator
- Confirmed systemic AL amyloidosis diagnosis by mass spectrometry or immunohistochemistry on tissue biopsy
- Received at least one prior therapy including an anti-CD38 monoclonal antibody
- Recovered from any transplant-related toxicities if history of autologous hematopoietic cell transplantation
- Presence of t(11;14) detected by FISH at any time since diagnosis
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
You will not qualify if you...
- Known allergy to any study drugs
- History of other malignancy affecting study compliance or results (exceptions for certain cured cancers)
- Clinically significant uncontrolled conditions including active infections
- Currently on renal replacement therapy
- Gastrointestinal disease or procedures affecting oral drug absorption
- New York Heart Association Class III or IV heart failure
- Mayo stage IIIB with NT-Pro BNP over 8500 pg/mL
- Previous treatment with anti-apoptotic BCL-2 inhibitors
- HIV not on antiretroviral therapy or active hepatitis A, B, or C infection
- Symptomatic multiple myeloma meeting specific clinical criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
2
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
4
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
R
Research Nurse Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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