Actively Recruiting
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
Led by SWOG Cancer Research Network · Updated on 2026-05-06
338
Participants Needed
117
Research Sites
330 weeks
Total Duration
On this page
Sponsors
S
SWOG Cancer Research Network
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have biopsy-proven systemic AL amyloidosis confirmed by specific tests
- Have measurable disease defined by monoclonal protein or plasma cells and free light chain difference 2 mg/dL
- Be 18 years or older
- Have ECOG performance status of 0, 1, or 2 (3 allowed if due to neuropathy)
- Complete medical history and physical exam within 28 days prior to registration
- Be willing to undergo high-dose chemotherapy and autologous stem cell transplant if assigned
- Eligible for high-dose melphalan chemotherapy at 200 mg/m2 or 140 mg/m2
- Have adequate blood counts and organ function within specified limits
- Have no uncontrolled infection or uncontrolled diabetes
- Not be seropositive for hepatitis B; if history of hepatitis C, must be treated and cured or have undetectable viral load
- Not have concurrent multiple myeloma or lytic bone disease
- Not have allergies to study drugs
- Not have had major surgery within 14 days prior to registration
- Not have severe chronic obstructive pulmonary disease or uncontrolled asthma
- Not be pregnant or nursing and agree to use effective contraception if of reproductive potential
- Able to complete patient-reported outcome questionnaires in English, Spanish, or French
- Meet additional criteria at each study step including response to induction therapy and ability to undergo assigned treatments
You will not qualify if you...
- Have uncontrolled infection or active anti-infectious therapy without study chair approval
- Have uncontrolled blood pressure or hypertension within 14 days prior to registration
- Be seropositive for hepatitis B, or PCR positive for hepatitis B DNA if antibodies present
- Have uncontrolled asthma (moderate or severe persistent) within past 2 years or currently uncontrolled
- Have uncontrolled diabetes within 28 days prior to registration
- Have prior or concurrent malignancy that may interfere with study assessments
- Have had vaccination with live attenuated vaccines within 28 days prior to registration
- Be pregnant or nursing
- Have severe cardiac AL amyloidosis as defined by specific cardiac biomarkers and function thresholds
- Have multiple myeloma with lytic bone disease, plasmacytomas, 60% plasma cells in bone marrow, or hypercalcemia
- Have known allergies to any of the study drugs
- Have major surgery within 14 days prior to registration
- Have chronic obstructive pulmonary disease with forced expiratory volume below 50% predicted
- Have uncontrolled infection as determined by enrolling physician
- Have uncontrolled blood pressure or hypertension
- Have uncontrolled diabetes
- Have uncontrolled asthma
- Have uncontrolled infection at the discretion of the enrolling physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 117 locations
1
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
3
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
4
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
5
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
6
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
7
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
8
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Actively Recruiting
9
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States, 06830
Actively Recruiting
10
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
11
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Actively Recruiting
12
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
13
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
Actively Recruiting
14
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States, 06902
Actively Recruiting
15
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
16
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
17
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
18
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
19
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States, 33065
Actively Recruiting
20
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
21
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States, 33021
Actively Recruiting
22
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
23
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
24
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States, 33181
Actively Recruiting
25
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
26
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
27
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
28
Rush-Copley Medical Center
Aurora, Illinois, United States, 60504
Actively Recruiting
29
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
30
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
31
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
32
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
33
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
34
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
35
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
36
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
37
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
38
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
39
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
40
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
41
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
42
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
43
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Actively Recruiting
44
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
45
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
46
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, United States, 48183
Actively Recruiting
47
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, United States, 48038
Actively Recruiting
48
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Actively Recruiting
49
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
50
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
51
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
52
Allegiance Health
Jackson, Michigan, United States, 49201
Actively Recruiting
53
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
54
Henry Ford Medical Center-Columbus
Novi, Michigan, United States, 48377
Actively Recruiting
55
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
56
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, United States, 48192
Actively Recruiting
57
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
58
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
59
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
60
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
61
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
62
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
63
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
64
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States, 38655
Actively Recruiting
65
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States, 38671
Actively Recruiting
66
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
67
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
68
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
69
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
70
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
71
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States, 68123
Actively Recruiting
72
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States, 68118
Actively Recruiting
73
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
74
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
75
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
76
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
77
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
78
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
79
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
80
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
81
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
82
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
83
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, United States, 28078
Actively Recruiting
84
Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina, United States, 28117
Actively Recruiting
85
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
86
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
87
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
88
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Actively Recruiting
89
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Actively Recruiting
90
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
91
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
92
Oregon Health and Science University
Portland, Oregon, United States, 97239
Active, Not Recruiting
93
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
94
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
95
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
96
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
97
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States, 38017
Actively Recruiting
98
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States, 38120
Actively Recruiting
99
Houston Methodist San Jacinto Hospital
Baytown, Texas, United States, 77521
Actively Recruiting
100
Houston Methodist Cypress Hospital
Cypress, Texas, United States, 77429
Actively Recruiting
101
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
102
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
103
Methodist Willowbrook Hospital
Houston, Texas, United States, 77070
Actively Recruiting
104
Houston Methodist West Hospital
Houston, Texas, United States, 77094
Actively Recruiting
105
Houston Methodist Saint John Hospital
Nassau Bay, Texas, United States, 77058
Actively Recruiting
106
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States, 77479
Actively Recruiting
107
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States, 77385
Actively Recruiting
108
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
109
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Actively Recruiting
110
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
111
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
112
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
113
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
114
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Actively Recruiting
115
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
116
Sheboygan Physicians Group
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
117
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235-1495
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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