Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocatio… (NCT05486481) | Clinical Trial Compass
WithdrawnPhase 1/2
Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE)
Stopped: Industry sponsor unable to continue support
0Started 2024-01-08
Plain-language summary
This phase I/II trial tests the safety, side effects, and best dose of venetoclax, daratumumab, and dexamethasone for the treatment of systemic light-chain amyloidosis in patients with a deoxyribonucleic acid (DNA) abnormality called a translocation involving chromosomes 11 and 14, or "t(11;14)". Venetoclax works by attaching to a protein called Bcl-2, in order to kill cancer cells. Daratumumab works by binding to a target on the surface of cancer cells called Cluster of differentiation 38 (CD38). When daratumumab binds to CD38, it enables the immune system to find the cancer cell and kill it. Dexamethasone is a type of drug called a corticosteroid. A corticosteroid is a drug made of artificial steroid hormones, that are used to treat symptoms such as inflammation (swelling and irritation to a part of the body). The combination of these medications may more effectively treat patients with systemic light-chain amyloidosis and t(11;14).
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
. Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry (IHC) and polarizing light microscopy of green bi-refringent material in Congo red-stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance.
. Presence of t(11;14) on bone marrow plasma cells (BMPC) by fluorescence in-situ hybridization (FISH), performed at the University of California San Francisco (UCSF) cytogenetics laboratory
. \>= 1 prior line of therapy for the treatment of systemic AL amyloidosis.
. No prior CD38-directed antibody treatment OR If the patient previously received CD38-directed antibody treatment, the patient achieved \>= partial response (PR) and did not progress while on CD38-directed antibody therapy. Progression on CD38-directed antibody treatment will be defined as progressive disease while on therapy or within 60 days of last dose.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Proportion of participants with reported dose limiting toxicities (Phase 1)
Timeframe: Up to 1 cycle (1 cycle is equal to 28 days)
2
Maximum tolerated dose (MTD) (Phase 1)
Timeframe: Up to 1 cycle (1 cycle is equal to 28 days)
3
Recommended phase 2 dose (RP2D) (Phase1)
Timeframe: Up to 1 cycle (1 cycle is equal to 28 days)
4
Proportion of participants who achieve a complete hematologic response (CHR) (Phase 2)
. Measurable disease of light chain amyloidosis as defined by at least ONE of the following:
. Serum M-protein \>= 0.5 g/dL by protein electrophoresis (routine serum protein electrophoresis and immunofixation (IFE) performed at a local laboratory),
. Serum free light chain \>= 40mg/L with an abnormal kappa:lambda ratio or
. The difference between involved and uninvolved free light chains (dFLC) \>= 20 mg/L.
. One or more organs impacted by AL amyloidosis according to consensus guidelines.
. Eastern Cooperative Oncology Group (ECOG) performance status =\< 2.
. Pretreatment clinical laboratory values meeting the following criteria during the Screening Phase (within 1 day of C1D1):
. Absolute neutrophil count \>= 1.0 × 10\^9/L without growth factor support for 7 days (14 days if pegfilgrastim).