A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
NCT ID: NCT05250973
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
151 participants
INTERVENTIONAL
2022-03-01
2027-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort1 (Arm A): Daratumumab + Immediate Cyclophosphamide, Bortezomib and Dexamethasone (VCd)
Participants with newly diagnosed systemic amyloid light chain (AL) amyloidosis with Mayo Cardiac Stage II and IIIa cardiac involvement will receive daratumumab 1800 milligrams (mg) subcutaneously (SC) starting on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] either orally or intravenously \[IV\], bortezomib 1.3 mg/m\^2 SC or IV, dexamethasone 40 mg weekly either orally or IV) weekly starting at Cycle 1 Day 1 up to Day 22 in every 28-day cycle for a maximum of 6 cycles (Cycle 6 Day 22).
Daratumumab
Daratumumab will be administered subcutaneously.
Cyclophosphamide
Cyclophosphamide will be administered either orally or IV.
Bortezomib
Bortezomib will be administered by SC injection or IV.
Dexamethasone
Dexamethasone will be administered orally or IV.
Cohort1 (Arm B): Daratumumab + Deferred VCd
Participants with newly diagnosed systemic AL amyloidosis with Mayo Cardiac Stage II and IIIa cardiac involvement will receive SC daratumumab 1800mg on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (Cyclophosphamide 300 mg/m\^2 either orally or IV, Bortezomib 1.3 mg/m\^2 SC or IV, Dexamethasone 40 mg weekly either orally or IV) starting at Cycle 4 Day 1, weekly (Days 1, 8, 15, 22) in every 28-day cycle for a maximum of 6 cycles (Cycle 9 Day 22).
Daratumumab
Daratumumab will be administered subcutaneously.
Cyclophosphamide
Cyclophosphamide will be administered either orally or IV.
Bortezomib
Bortezomib will be administered by SC injection or IV.
Dexamethasone
Dexamethasone will be administered orally or IV.
Cohort 2: Daratumumab + VCd
Participants with racial and ethnic minorities, including Black or African American participants, with newly diagnosed AL amyloidosis will receive SC injection of daratumumab 1800 mg SC on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] either orally or intravenously \[IV\], bortezomib 1.3 mg/m\^2 SC or IV, dexamethasone 40 mg weekly either orally or IV) weekly starting at Cycle 1 Day 1 up to Day 22 in every 28-day cycle for a maximum of 6 cycles (Cycle 6 Day 22).
Daratumumab
Daratumumab will be administered subcutaneously.
Cyclophosphamide
Cyclophosphamide will be administered either orally or IV.
Bortezomib
Bortezomib will be administered by SC injection or IV.
Dexamethasone
Dexamethasone will be administered orally or IV.
Interventions
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Daratumumab
Daratumumab will be administered subcutaneously.
Cyclophosphamide
Cyclophosphamide will be administered either orally or IV.
Bortezomib
Bortezomib will be administered by SC injection or IV.
Dexamethasone
Dexamethasone will be administered orally or IV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of cyclophosphamide or 100 days after discontinuation of daratumumab, whichever is longer
* Cohort 2 only: self-identified racial and ethnic minorities, including Black or African 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 Criteria
* Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, \>=60% plasma cells in the bone marrow, or hypercalcemia related to myeloma.
* Participant received any of the following therapies:
1. treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is less;
2. vaccinated with an investigational vaccine (except for COVID-19) live, attenuated or replicating viral vector vaccines less than (\<) 4 weeks prior to randomization/enrollment. Participants who are taking strong Cytochrome P450 3A4(CYP3A4) inducers must discontinue their use at least 5 half-lives prior to the first dose of bortezomib
* Stem cell transplantation -Planned stem cell transplant during the first 9 cycles of protocol therapy are excluded. Stem cell collection during the first 9 cycles of protocol therapy is permitted
* Grade 2 sensory or Grade 1 painful peripheral neuropathy
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope
Duarte, California, United States
Smilow Cancer Hospital/Yale Cancer Center
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Wake Forest University - Baptist Medical Center
Winston-Salem, North Carolina, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
VCU Medical Center
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
University Health Network UHN Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Peking University First Hospital
Beijing, , China
Peking University People s Hospital
Beijing, , China
West China Hospital Si Chuan University
Chengdu, , China
First affiliated Hospital of Zhejiang University
Hangzhou, , China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, , China
CHU de Limoges
Limoges, , France
Centre hospitalier Lyon-Sud
Pierre-Bénite, , France
CHU De Poitiers
Poitiers, , France
CHU Rangueil
Toulouse, , France
Charite Campus Benjamin Franklin
Berlin, , Germany
Universitatsklinikum Essen
Essen, , Germany
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg, , Germany
Alexandra General Hospital of Athens
Athens, , Greece
Università Degli Studi Di Napoli Federico Ii
Napoli, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
Roma, , Italy
University Medical Center Groningen
Groningen, , Netherlands
Hospital Maastricht University Medical Center
Maastricht, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Clinica Univ. de Navarra
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Leicester Royal Infirmary - Haematology
Leicester, , United Kingdom
University College Hospital
London, , United Kingdom
Countries
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Other Identifiers
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54767414AMY2009
Identifier Type: OTHER
Identifier Source: secondary_id
2021-002639-48
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-507069-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109160
Identifier Type: -
Identifier Source: org_study_id