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.

Who Can Join

To join this study, there are a few conditions. You must:

• Have newly diagnosed AL amyloidosis.
• Be able to walk and do routine activities for more than half the time you are awake.
• Be age 18 or older.

Contact

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