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RECRUITING
NCT06022939
PHASE3

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

View on ClinicalTrials.gov

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

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Given IV

PROCEDURE

Biopsy

Undergo fat pad biopsy

PROCEDURE

Biospecimen Collection

Undergo blood and urine specimen collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Bortezomib

Given SC

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given PO or IV

DRUG

Daratumumab and Hyaluronidase-fihj

Given SC

DRUG

Dexamethasone

Given PO or IV

PROCEDURE

Echocardiography

Undergo echocardiography

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Melphalan

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET-CT

PROCEDURE

Stem Cell Isolation

Undergo stem cell collection

OTHER

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