OncoMatch/Clinical Trials/NCT06022939
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
Is NCT06022939 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for al amyloidosis.
Treatment: Bortezomib · Cyclophosphamide · Daratumumab and Hyaluronidase-fihj · Dexamethasone · Melphalan — This phase III trial compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain (AL) amyloidosis. Melphalan is a chemotherapy given prior to a stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patients to replace the blood forming cells that were destroyed by the chemotherapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs, such as cyclophosphamide and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to lower the body's immune response to help stop the growth of cancer cells. Giving a stem cell transplant with melphalan after Dara-VCD may kill more cancer cells in patients with newly diagnosed AL amyloidosis.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Hemoglobin >= 8.0 g/dL; Leukocytes >= 2 x 10^3/uL; Absolute neutrophil count >= 1.0 x 10^3/uL; Platelets >= 50 x 10^3/uL
Kidney function
Serum creatinine <= institutional ULN OR measured/calculated creatinine clearance >= 30 mL/min
Liver function
Total bilirubin <= 1.5 x ULN unless history of Gilbert's disease (then <= 5 x ULN); Direct bilirubin <= 2.0 mg/dL; AST/ALT <= 3x ULN (except if secondary to hepatic involvement); Alkaline phosphatase <= 750 U/L (except if secondary to hepatic involvement)
Cardiac function
Non-severe cardiac AL: NT proBNP < 5000 (if no NTproBNP, BNP < 400); Troponin T < 0.06 (or hsTnT < 75 or troponin I < 0.1ng/dL); NYHA I or II; Cardiac ejection fraction >= 40%
See eligibility: Non-severe cardiac AL (NT proBNP < 5000, BNP < 400, TnT < 0.06, hsTnT < 75 or troponin I < 0.1ng/dL, NYHA I or II, EF >= 40%). Hemoglobin >= 8.0 g/dL; Leukocytes >= 2 x 10^3/uL; ANC >= 1.0 x 10^3/uL; Platelets >= 50 x 10^3/uL; Total bilirubin <= 1.5 x ULN unless Gilbert's disease; Direct bilirubin <= 2.0 mg/dL; AST/ALT <= 3x ULN; Alk phos <= 750 U/L; Creatinine <= ULN or CrCl >= 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Smilow Cancer Hospital-Derby Care Center · Derby, Connecticut
- Smilow Cancer Hospital Care Center - Guilford · Guilford, Connecticut
- Smilow Cancer Hospital Care Center at Saint Francis · Hartford, Connecticut
- Yale University · New Haven, Connecticut
- Yale-New Haven Hospital North Haven Medical Center · North Haven, Connecticut
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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