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NCT05250973Active, not recruitingPhase 2

A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
151 (actual)
First submitted
11 Feb 2022
Start date
1 Mar 2022
Primary completion date
4 Feb 2026
Lead sponsor
Janssen Research & Development, LLC
Diseases
Amyloidosis
NCT number
NCT05250973
EU CT number
2023-507069-25-00
EudraCT number
2021-002639-48

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 151
  • From 1 Mar 2022 to the primary completion date, 4 Feb 2026
  • 42 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior therapy for systemic AL amyloidosis or multiple myeloma including medications that target cluster of differentiation 38 (CD38), with the exception of 160 milligrams(mg) dexamethasone or equivalent corticosteroid maximum exposure prior to randomization/enrollment
  • 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:
    • treatment with an investigational drug or used an invasive investigational medical 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 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

Other

  • Grade 2 sensory or Grade 1 painful peripheral neuropathy

Who the study is looking for

  • Cohort 1: Cardiac involvement (amyloid light chain \[AL\] amyloidosis Mayo Cardiac Stage II and Stage IIIa) with or without other organ(s) involved; Cohort 2: One or more 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 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tom Baker Cancer Center
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
University Health Network UHN Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
West China Hospital Si Chuan University
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ChengduChinaUnknown status
First Affiliated Hospital of Zhejiang University
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HangzhouChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyCompleted
Institut Catala d'Oncologia
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BadalonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Clinica Universidad de Navarra
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MadridSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Leicester Royal Infirmary - Haematology
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LeicesterUnited KingdomUnknown status
University College Hospital
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LondonUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceCompleted
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyCompleted
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyCompleted
Universitair Medisch Centrum Groningen
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GroningenNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Winship Cancer Institute, Emory University
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AtlantaUnited StatesUnknown status
Tufts Medical Center
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BostonUnited StatesUnknown status
Boston University Medical Center
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BostonUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
University Hospital of Cleveland
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ClevelandUnited StatesUnknown status
Ohio Health Research Institute
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ColumbusUnited StatesUnknown status
UT Southwestern Medical Center
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DallasUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
Yale
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New HavenUnited StatesUnknown status
Memorial Sloan Kettering
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New YorkUnited StatesUnknown status
West Penn Hospital
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PittsburghUnited StatesUnknown status
VCU Medical Center
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RichmondUnited StatesUnknown status
University of Washington
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SeattleUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Wake Forest University Baptist Medical Center
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.