Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
Sponsor: SWOG Cancer Research Network
Summary
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
338
Start Date
2024-07-01
Completion Date
2030-10-29
Last Updated
2026-05-06
Healthy Volunteers
No
Conditions
Interventions
Autologous Hematopoietic Stem Cell Transplantation
Given IV
Biopsy
Undergo fat pad biopsy
Biospecimen Collection
Undergo blood and urine specimen collection
Bone Marrow Aspiration
Undergo bone marrow aspiration
Bone Marrow Biopsy
Undergo bone marrow biopsy
Bortezomib
Given SC
Computed Tomography
Undergo CT scan
Cyclophosphamide
Given PO or IV
Daratumumab and Hyaluronidase-fihj
Given SC
Dexamethasone
Given PO or IV
Echocardiography
Undergo echocardiography
Magnetic Resonance Imaging
Undergo MRI
Melphalan
Given IV
Positron Emission Tomography
Undergo PET-CT
Stem Cell Isolation
Undergo stem cell collection
Survey Administration
Ancillary study
Locations (117)
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, United States
Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Houston Methodist San Jacinto Hospital
Baytown, Texas, United States
Houston Methodist Cypress Hospital
Cypress, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Methodist Willowbrook Hospital
Houston, Texas, United States
Houston Methodist West Hospital
Houston, Texas, United States
Houston Methodist Saint John Hospital
Nassau Bay, Texas, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States
Sheboygan Physicians Group
Sheboygan, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States