RecruitingPhase 1/2

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

United States53 participantsStarted 2022-10-26

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically for AL amyloidosis with a t(11;14) genetic change — has my amyloidosis been tested for this chromosomal abnormality, and do my results suggest I might be a candidate worth discussing with you?
2Since this is a Phase 1/2 trial, the first part is still figuring out safe doses of venetoclax combined with dexamethasone — what does that mean for what's currently known about the risks and side effects I might face compared to established treatments?
3The trial is measuring 'Very Good Partial Response' as a key goal in Phase 2 — can you explain what that hematologic response level means for my type of amyloidosis and how it compares to what standard salvage therapies typically achieve?
4Because my disease is relapsed or refractory, I'd like to understand whether trying a standard second-line regimen first makes more sense than enrolling in an early-phase trial — what would you recommend and why?
5Venetoclax requires careful monitoring and is combined with dexamethasone, which has its own side effects — given my current organ involvement from amyloidosis, do you think my heart or kidneys could make participating in this trial more complicated or risky for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Dose Limiting Toxicities (DLT) (Phase 1)

Timeframe: Up to 6 cycles (approximately 6 months)

Hematologic ≥ Very Good Partial Response (VGPR) Rate (Phase 2)

Timeframe: Up to 6 cycles (approximately 6 months)

Trial details

NCT IDNCT05451771

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Research Nurse Navigator

212-342-5162 cancerclinicaltrials@cumc.columbia.edu

View on ClinicalTrials.gov More AL Amyloidosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.