A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis (AQUARIUS)
Last Updated May 14, 2025
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CR109160
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 2 -
Sites
Sites -
Status
Recruiting
SUMMARY
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).
CONDITIONS
- Amyloidosis
ELIGIBILITY
Inclusion Criteria:
* 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 Co
DETAILS
LOCATIONS
| Country (10) | City or Province (46) | Status |
| United States | New Haven Smilow Cancer Hospital/Yale Cancer Center |
RECRUITING
|
| United States | Tampa Moffitt Cancer Center |
RECRUITING
|
| United States | Atlanta Winship Cancer Institute Emory University |
RECRUITING
|
| United States | Boston Tufts Medical Center |
RECRUITING
|
| United States | Boston Boston University Medical Center |
RECRUITING
|
| United States | Detroit Barbara Ann Karmanos Cancer Institute |
RECRUITING
|
| United States | New York Memorial Sloan Kettering |
RECRUITING
|
| United States | Charlotte Levine Cancer Institute |
RECRUITING
|
| United States | Columbus Ohio Health Research Institute |
RECRUITING
|
| United States | Dallas UT Southwestern Medical Center |
RECRUITING
|
| United States | Richmond VCU Medical Center |
RECRUITING
|
| Canada | Edmonton Cross Cancer Institute |
RECRUITING
|
| China | Beijing Peking University First Hospital |
RECRUITING
|
| China | Beijing Peking University People s Hospital |
RECRUITING
|
| China | Chengdu West China Hospital Si Chuan University |
RECRUITING
|
| China | Hangzhou First affiliated Hospital of Zhejiang University |
RECRUITING
|
| China | Shanghai Ruijin Hospital Shanghai Jiao Tong University |
RECRUITING
|
| France | Limoges Cedex CHU de Limoges |
COMPLETED
|
| France | Pierre Benite cedex Centre hospitalier Lyon-Sud |
RECRUITING
|
| France | Poitiers CHU De Poitiers |
RECRUITING
|
| France | Toulouse CHU Rangueil |
RECRUITING
|
| Germany | Essen Universitatsklinikum Essen |
COMPLETED
|
| Greece | Athens Alexandra General Hospital of Athens |
RECRUITING
|
| Italy | Napoli Università Degli Studi Di Napoli Federico Ii |
RECRUITING
|
| Italy | Pavia Fondazione IRCCS Policlinico San Matteo |
RECRUITING
|
| Italy | Roma DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA'' |
COMPLETED
|
| Netherlands | Groningen University Medical Center Groningen |
RECRUITING
|
| Netherlands | Maastricht Hospital Maastricht University Medical Center |
COMPLETED
|
| Netherlands | Utrecht UMC Utrecht |
RECRUITING
|
| Spain | Badalona Hosp. Univ. Germans Trias I Pujol |
RECRUITING
|
| Spain | Barcelona Hosp Univ Vall D Hebron |
RECRUITING
|
| Spain | Barcelona Hosp Clinic de Barcelona |
RECRUITING
|
| Spain | Madrid Clinica Univ. de Navarra |
RECRUITING
|
| Spain | Pamplona Clinica Univ. de Navarra |
RECRUITING
|
| Spain | Salamanca Hosp Clinico Univ de Salamanca |
RECRUITING
|
| United Kingdom | Leicester Leicester Royal Infirmary - Haematology |
RECRUITING
|
| United Kingdom | London University College Hospital |
RECRUITING
|
| United States | Pittsburgh West Penn Hospital |
COMPLETED
|
| Canada | Toronto University Health Network UHN Princess Margaret Cancer Centre |
COMPLETED
|
| United States | Winston-Salem Wake Forest University - Baptist Medical Center |
RECRUITING
|
| United States | Cleveland University Hospital of Cleveland |
COMPLETED
|
| Canada | Calgary Tom Baker Cancer Center |
COMPLETED
|
| Germany | Berlin Charite Campus Benjamin Franklin |
COMPLETED
|
| Germany | Heidelberg Universitaetsklinikum Heidelberg Medizinische Klinik V |
COMPLETED
|
| United States | Duarte City of Hope |
COMPLETED
|
| United States | Seattle University of Washington |
COMPLETED
|
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