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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

2025-09-15

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 (35)

Smilow Cancer Hospital-Derby Care Center

Derby, 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

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

Mission Cancer and Blood - Ankeny

Ankeny, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Mission Cancer and Blood - Des Moines

Des Moines, 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

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 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

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

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States