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

Protocol No
SWOG-S2213
Phase
III
Summary

This study is being done to answer the following questions:
- Do people with AL amyloidosis respond better to a consolidation treatment that uses either
one high dose of the drug melphalan plus stem cell transplant or more chemotherapy
alone?
- Which treatment plan gives patients a better quality of life?
To determine which treatment plan works better against AL amyloidosis, the study is set up to find out how good the treatments are at lowering the chance of AL amyloidosis causing problems in major organs of the body. The researchers will compare the results from each treatment group.

Description
This study is being done to answer the following questions:
- Do people with AL amyloidosis respond better to a consolidation treatment that uses either
one high dose of the drug melphalan plus stem cell transplant or more chemotherapy
alone?
- Which treatment plan gives patients a better quality of life?
To determine which treatment plan works better against AL amyloidosis, the study is set up to find out how good the treatments are at lowering the chance of AL amyloidosis causing problems in major organs of the body. The researchers will compare the results from each treatment group.
Status
IRB INITIAL APPROVAL