Actively Recruiting
A Phase III Randomized Study of Dara-VCD Induction Followed by Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Newly Diagnosed AL Amyloidosis
Led by SWOG Cancer Research Network · Updated on 2026-05-06
338
Participants Needed
117
Research Sites
13 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
Researchers are evaluating the addition of a stem cell transplant with melphalan after chemotherapy with daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) compared to Dara-VCD chemotherapy alone for patients newly diagnosed with amyloid light chain (AL) amyloidosis. This phase III trial aims to assess outcomes such as major organ deterioration progression-free survival, overall survival, organ response rates, and quality of life. The study also investigates minimal residual disease negativity and treatment-related side effects. Participants initially receive induction therapy with Dara-VCD drugs over a series of 28-day cycles, including daratumumab and hyaluronidase-fihj subcutaneously, bortezomib subcutaneously, cyclophosphamide orally or intravenously, and dexamethasone orally or intravenously. After induction, those with a partial response or better are randomized to one of two consolidation arms: either continued Dara-VCD chemotherapy or high-dose melphalan chemotherapy followed by autologous stem cell transplant. Following consolidation, patients receive maintenance daratumumab and hyaluronidase-fihj therapy every 28 days for up to 18 cycles, unless the disease progresses or unacceptable toxicity occurs. Throughout the study, participants undergo multiple assessments including CT, MRI, or PET-CT scans, fat pad biopsies, echocardiography, bone marrow aspiration and biopsies, and blood and urine sample collections at regular intervals. Patient-reported outcomes related to physical function, fatigue, and symptoms are collected using standardized questionnaires. After completing study treatment, patients are followed up every 3 to 6 months for up to 4 years to monitor progression and overall health.
CONDITIONS
Brief 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...
- Adults 18 years or older with biopsy-proven systemic AL amyloidosis confirmed by Congo red stain or electron microscopy and AL amyloid typing
- Measurable disease as shown by monoclonal serum or urine immunofixation, or monoclonal plasma cells in bone marrow, plus involved-uninvolved free light chain difference ≥ 2 mg/dL
- May have received up to one 28-day cycle of therapy prior to enrollment
- Allowance for chronic corticosteroids if for non-AL amyloidosis conditions
- ECOG performance status of 0, 1, or 2 (3 allowed if neuropathy-related)
- Complete medical history and physical exam within 28 days prior to registration
- Willingness to undergo high-dose chemotherapy and autologous stem cell transplantation if assigned
- Eligibility to receive melphalan at 200 mg/m² or 140 mg/m²
- Adequate heart function defined by blood pressure, NT proBNP, troponin levels, NYHA class I or II, and ejection fraction ≥ 40%
- Adequate blood counts and organ function within specified laboratory limits
- Negative for active hepatitis B and treated or cured hepatitis C
- No concurrent multiple myeloma
- No known allergies to study drugs
- No major surgery within 14 days prior to registration
- No severe chronic obstructive pulmonary disease or uncontrolled asthma
- Controlled HIV infection with undetectable viral load
- Not pregnant or nursing, with agreement to effective contraception
- Willingness to participate in specimen banking and patient-reported outcome assessments
- Completion of induction therapy and partial response prior to randomization (Step 2)
- Ability to initiate consolidation therapy within 8 weeks after randomization
- Ability to return to treatment center if randomized to stem cell transplant arm
- No major organ deterioration progression-free survival event prior to Step 2 and Step 3 registrations
- Ability to complete follow-up assessments in English, Spanish, or French
You will not qualify if you...
- Known allergies to any study drugs
- Major surgery within 14 days prior to registration
- Chronic obstructive pulmonary disease with FEV1 less than 50% predicted
- Moderate or severe persistent asthma within past 2 years or uncontrolled asthma
- Uncontrolled diabetes or hypertension prior to registration
- Active, uncontrolled infection or on ongoing antimicrobial therapy without clearance
- Seropositive for hepatitis B surface antigen or positive HBV DNA by PCR if resolved infection
- Untreated or active hepatitis C infection
- Concurrent multiple myeloma with lytic bone disease, plasmacytomas, ≥ 60% plasma cells in bone marrow, or hypercalcemia
- Prior or concurrent malignancy that may interfere with study assessments
- Receipt of live attenuated vaccines within 28 days prior to registration
- Pregnancy or breastfeeding
- Unwillingness to undergo high-dose chemotherapy and stem cell transplant if assigned
- Inability to complete patient-reported outcomes questionnaires in English, Spanish, or French
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 cycles of 28 days each
Participants receive daratumumab and hyaluronidase-fihj subcutaneously on specified days along with bortezomib, cyclophosphamide, and dexamethasone in 28-day cycles for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Multiple visits per cycle; daratumumab given days 1, 8, 15, and 22 for 2 cycles and days 1 and 15 for cycle 3; bortezomib, cyclophosphamide, and dexamethasone given days 1, 8, 15, and 22 of each cycle
Duration - Up to 3 cycles of 28 days for Arm I; 1 cycle melphalan plus stem cell transplant timing varies for Arm II
Participants who respond to induction are randomized to one of two consolidation treatments: Arm I receives daratumumab, bortezomib, cyclophosphamide, and dexamethasone for up to 3 cycles; Arm II undergoes stem cell collection followed by melphalan and autologous stem cell transplant.
Arm I: Visits on days 1, 8, 15, and 22 each cycle with daratumumab on days 1 and 15; Arm II: Stem cell collection visit(s), melphalan treatment, and stem cell transplant visits
Duration - Up to 18 cycles of 28 days each
Participants receive maintenance daratumumab and hyaluronidase-fihj subcutaneously on day 1 of each 28-day cycle for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
1 visit per 28-day cycle
Duration - Up to 4 years
After completion of study treatment, participants are followed up every 3 or 6 months for up to 4 years to monitor health and disease status.
Visits every 3 or 6 months
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here