A Phase 3 Study Assessing Dara-VCD Chemotherapy Alone or With a Stem Cell Transplant for People With Newly Diagnosed AL Amyloidosis

Full Title

A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis (S2213) (CIRB)

Purpose

Researchers are comparing combination chemotherapy alone or with a stem cell transplant for people with amyloid light chain (AL) amyloidosis. The people in this study have newly diagnosed AL amyloidosis. The chemotherapy includes daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD).

If you join this study, you will be randomly assigned to get one of these treatments:

  • Dara-VCD alone.
  • Dara-VCD followed by a stem cell transplant with melphalan. Giving melphalan before a stem cell transplant helps kill cancer cells and makes room for new blood-forming cells to grow.

A stem cell transplant with melphalan after Dara-VCD may kill more cancer cells in people with newly diagnosed AL amyloidosis.

Contact

For more information or to see if you can join this study, please call Dr. Heather Landau’s office at 646-608-3740.

Protocol
25-107
Phase
Phase III (phase 3)
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT06022939