Phase
Condition
Amyloidosis
Treatment
Bortezomib
Cyclophosphamide
Dexamethasone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Cohort 1: Cardiac involvement (amyloid light chain [AL] amyloidosis Mayo CardiacStage II and Stage IIIa) with or without other organ(s) involved; Cohort 2: One ormore organs impacted by systemic AL amyloidosis according to consensus guidelines
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
A female participant of childbearing potential must have a negative serum or urinetest at screening and within 72 hours of the first dose of study treatment and mustagree to further serum or urine pregnancy tests during the study
A male participant must agree not to donate sperm for the purpose of reproductionduring the study and for a minimum of 6 months after receiving the last dose ofcyclophosphamide or 100 days after discontinuation of daratumumab, whichever islonger
Cohort 2 only: self-identified racial and ethnic minorities, including Black orAfrican American
Measurable disease at screening defined by one of the following:
Difference between iFLC and uninvolved FLC (dFLC) >= 40mg/L per central laboratory Serum involved free light chain (iFLC) >= 40 mg/L with an abnormal kappa:lambda ratio Serum M-protein >= 0.5 g/dL
Exclusion
Exclusion Criteria:
Prior therapy for systemic AL amyloidosis or multiple myeloma including medicationsthat target cluster of differentiation 38 (CD38), with the exception of 160milligrams(mg) dexamethasone or equivalent corticosteroid maximum exposure prior torandomization/enrollment
Previous or current diagnosis of symptomatic multiple myeloma, including thepresence of lytic bone disease, plasmacytomas, >=60% plasma cells in the bonemarrow, or hypercalcemia related to myeloma.
Participant received any of the following therapies:
treatment with an investigational drug or used an invasive investigationalmedical device within 14 days or at least 5 half-lives, whichever is less;
vaccinated with an investigational vaccine (except for COVID-19) live,attenuated or replicating viral vector vaccines less than (<) 4 weeks prior torandomization/enrollment. Participants who are taking strong Cytochrome P450 3A4(CYP3A4) inducers must discontinue their use at least 5 half-lives prior tothe first dose of bortezomib
Stem cell transplantation -Planned stem cell transplant during the first 9 cycles ofprotocol therapy are excluded. Stem cell collection during the first 9 cycles ofprotocol therapy is permitted
Grade 2 sensory or Grade 1 painful peripheral neuropathy
Study Design
Connect with a study center
Tom Baker Cancer Center
Calgary, Alberta T2N 4N2
CanadaCompleted
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
University Health Network UHN Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaCompleted
Peking University First Hospital
Beijing, 100034
ChinaActive - Recruiting
Peking University People s Hospital
Beijing, 100044
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, 100044
ChinaActive - Recruiting
West China Hospital Si Chuan University
Chengdu, 610041
ChinaActive - Recruiting
West China Hospital, Si Chuan University
Chengdu, 610041
ChinaActive - Recruiting
First affiliated Hospital of Zhejiang University
Hangzhou, 310020
ChinaActive - Recruiting
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
ChinaActive - Recruiting
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, 200025
ChinaActive - Recruiting
CHU de Limoges
Limoges Cedex, 87042
FranceCompleted
Centre hospitalier Lyon-Sud
Pierre Benite cedex, 69495
FranceActive - Recruiting
CHU De Poitiers
Poitiers, 86000
FranceActive - Recruiting
CHU Rangueil
Toulouse, 31400
FranceActive - Recruiting
Charite Campus Benjamin Franklin
Berlin, 12203
GermanyCompleted
Universitatsklinikum Essen
Essen, 45122
GermanyCompleted
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg, 69120
GermanyCompleted
Alexandra General Hospital of Athens
Athens, 11528
GreeceActive - Recruiting
Università Degli Studi Di Napoli Federico Ii
Napoli, 80131
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalyActive - Recruiting
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
Roma, 00161
ItalyCompleted
A.O.Citta della Salute e della Scienza di Torino
Torino, 10126
ItalySite Not Available
University Medical Center Groningen
Groningen, 9713 GZ
NetherlandsActive - Recruiting
Hospital Maastricht University Medical Center
Maastricht, 6229 HX
NetherlandsCompleted
UMC Utrecht
Utrecht, 3584 CX
NetherlandsActive - Recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
SpainCompleted
Hosp Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Univ. Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Clinica Univ. de Navarra
Madrid, 28027
SpainActive - Recruiting
Clinica Univ. de Navarra
Pamplona, 31008
SpainActive - Recruiting
Hosp Clinico Univ de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hosp. Clinico Univ. de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Leicester Royal Infirmary - Haematology
Leicester, LE1 5WW
United KingdomActive - Recruiting
University College Hospital
London, NW1 2PG
United KingdomActive - Recruiting
City of Hope
Duarte, California 91010
United StatesCompleted
Smilow Cancer Hospital/Yale Cancer Center
New Haven, Connecticut 06510
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
Winship Cancer Institute Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
Johns Hopkins University School of Medicine (JHUSOM)
Baltimore, Maryland 21231
United StatesSite Not Available
Boston University Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Tufts Medical Center
Boston, Massachusetts 02111
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Washington Univ School of Meds - Div of Oncology
Saint Louis, Missouri 63110
United StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
United StatesSite Not Available
Memorial Sloan Kettering
New York, New York 10021
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Wake Forest University - Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesCompleted
University Hospital of Cleveland
Cleveland, Ohio 44106
United StatesCompleted
Ohio Health Research Institute
Columbus, Ohio 43214
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107-4215
United StatesSite Not Available
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesCompleted
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesActive - Recruiting
Houston Methodist Cancer Center
Houston, Texas 77030
United StatesSite Not Available
VCU Medical Center
Richmond, Virginia 23219
United StatesActive - Recruiting
University of Washington
Seattle, Washington 90805
United StatesCompleted
Medical College Of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.