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

Contact:

NCT Number:

Protocol:

AAAV1305

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

This study is being done to answer the following questions: • Do people with amyloid light chain (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.

Are you Eligible? (Inclusion Criteria)

  • Are you 18 years of age or older? Have you been diagnosed with AL amyloidosis that has not been treated yet (or you have received only a small amount of treatment)? Are you able to make regularly scheduled visits to the clinic for treatment and examinations?

Specialty Area(s)

Multiple Myeloma/Amyloidosis

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032