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 range18 Years
SexALL
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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.
Exclusion criteria
✕. 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),
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)