Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis (NCT06022939)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: CTCA at Western Regional Medical Center — Goodyear, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (117 Sites)
Showing the first 25 of 117 sites.
- CTCA at Western Regional Medical Center — Goodyear, Arizona
- Banner University Medical Center - Tucson — Tucson, Arizona
- University of Arizona Cancer Center-North Campus — Tucson, Arizona
- City of Hope Comprehensive Cancer Center — Duarte, California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- City of Hope at Irvine Lennar — Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich, 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
- Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Coral Springs — Coral Springs, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
- UM Sylvester Comprehensive Cancer Center at Hollywood — Hollywood, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida
- University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida
📞 Contact the Study Coordinator
Phone: (623) 207-3000
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in AL Amyloidosis
- Ixazomib Maintenance Study in Patients With AL Amyloidosis — Boston, Massachusetts
- Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis — Boston, Massachusetts
- Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis — Orange, California
- A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES) — Duarte, California
- A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES) — Scottsdale, Arizona
- A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement — Palo Alto, California
Explore by condition: All AL Amyloidosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.