A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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).
Eligibility
Primary outcome measure(s)
- Number of Participants with Cardiac Events of Any Toxicity Grade — Up to 12 months
Number of participants with cardiac events of any toxicity grade will be reported. - Observed Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) of Daratumumab — Cycle 3 Day 1 predose (each cycle is of 28 days)
Ctrough is defined as the observed concentration immediately prior to the next study treatment administration.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | |
| Yale | New Haven | Connecticut | |
| Moffitt Cancer Center | Tampa | Florida | |
| Winship Cancer Institute Emory University | Atlanta | Georgia | |
| Tufts Medical Center | Boston | Massachusetts | |
| Boston University Medical Center | Boston | Massachusetts | |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | |
| Memorial Sloan Kettering | New York | New York | |
| Levine Cancer Institute | Charlotte | North Carolina | |
| Wake Forest University - Baptist Medical Center | Winston-Salem | North Carolina | |
| University Hospital of Cleveland | Cleveland | Ohio | |
| Ohio Health Research Institute | Columbus | Ohio | |
| West Penn Hospital | Pittsburgh | Pennsylvania | |
| UT Southwestern Medical Center | Dallas | Texas | |
| VCU Medical Center | Richmond | Virginia | |
| University of Washington | Seattle | Washington | |
| Tom Baker Cancer Center | Calgary | Alberta | |
| Cross Cancer Institute | Edmonton | Alberta | |
| University Health Network UHN Princess Margaret Cancer Centre | Toronto | Ontario | |
| 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 | Naples | 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 |
+ 6 more sites — see the full list on the official registry below.
On this site
📄 Darzalex (daratumumab) drug profile →More Janssen Research & Development, LLC trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05250973 on ClinicalTrials.gov ↗ ← All trials in Italy