Phase
Condition
Amyloidosis
Treatment
Daratumumab
Bortezomib
Cyclophosphamide
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
CanadaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
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
CanadaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaSite Not Available
Peking University People's Hospital
Beijing, 100044
ChinaSite Not Available
Peking University First Hospital
Beijing 1816670, 100034
ChinaSite Not Available
Peking University People s Hospital
Beijing 1816670, 100044
ChinaSite Not Available
West China Hospital Si Chuan University
Chengdu, 610041
ChinaSite Not Available
West China Hospital, Si Chuan University
Chengdu, 610041
ChinaActive - Recruiting
First affiliated Hospital of Zhejiang University
Hangzhou, 310003
ChinaSite Not Available
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, 200025
ChinaActive - Recruiting
CHU de Limoges
Limoges, 87042
FranceSite Not Available
CHU de Limoges
Limoges Cedex, 87042
FranceActive - Recruiting
Centre hospitalier Lyon-Sud
Pierre Benite cedex, 69495
FranceActive - Recruiting
Centre hospitalier Lyon-Sud
Pierre-Bénite, 69495
FranceSite Not Available
CHU De Poitiers
Poitiers, 86000
FranceSite Not Available
CHU Rangueil
Toulouse, 31400
FranceSite Not Available
Charite Campus Benjamin Franklin
Berlin, 12203
GermanySite Not Available
Universitatsklinikum Essen
Essen, 45122
GermanySite Not Available
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg, 69120
GermanySite Not Available
Alexandra General Hospital of Athens
Athens, 11528
GreeceSite Not Available
Università Degli Studi Di Napoli Federico Ii
Naples, 80131
ItalySite Not Available
Università Degli Studi Di Napoli Federico Ii
Napoli, 80131
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
Roma, 00161
ItalySite Not Available
University Medical Center Groningen
Groningen, 9713 GZ
NetherlandsSite Not Available
Hospital Maastricht University Medical Center
Maastricht, 6229 HX
NetherlandsSite Not Available
UMC Utrecht
Utrecht, 3584 CX
NetherlandsSite Not Available
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
SpainSite Not Available
Hosp Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainSite Not Available
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
Hosp Clinic de Barcelona
Barcelona 3128760, 08036
SpainSite Not Available
Clinica Univ. de Navarra
Madrid, 28027
SpainActive - Recruiting
Clinica Univ. de Navarra 1
Madrid, 28027
SpainSite Not Available
Clinica Univ. de Navarra
Pamplona, 31008
SpainSite Not Available
Hosp Clinico Univ de Salamanca
Salamanca, 37007
SpainSite Not Available
Hosp. Clinico Univ. de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Leicester Royal Infirmary - Haematology
Leicester, LE1 5WW
United KingdomSite Not Available
University College Hospital
London, NW1 2PG
United KingdomSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
Yale
New Haven, Connecticut 06520
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Winship Cancer Institute Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Boston University Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
United StatesSite Not Available
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Memorial Sloan Kettering
New York, New York 10065
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Wake Forest University - Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University Hospital of Cleveland
Cleveland, Ohio 44106
United StatesSite Not Available
Ohio Health Research Institute
Columbus, Ohio 43214
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
VCU Medical Center
Richmond, Virginia 23298
United StatesSite Not Available
University of Washington
Seattle, Washington 02118-30002
United StatesSite Not Available

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