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

Last Updated   April 30, 2025

Want to learn how to participate in this trial?

CR109160

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 2
    2
  • Sites
    46 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 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:

* 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:

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


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

More...

DETAILS

LOCATIONS

Locations in:
United States, Canada, China, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom
Country (10) City or Province (46) Status
United States Duarte City of Hope
RECRUITING
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
United States Seattle University of Washington
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
Show More
Geo Locations

34.13945, -117.97729

41.30815, -72.92816

27.94752, -82.45843

33.749, -84.38798

42.35843, -71.05977

42.35843, -71.05977

42.33143, -83.04575

40.71427, -74.00597

35.22709, -80.84313

39.96118, -82.99879

32.78306, -96.80667

37.55376, -77.46026

47.60621, -122.33207

53.55014, -113.46871

39.9075, 116.39723

39.9075, 116.39723

30.66667, 104.06667

30.29365, 120.16142

31.22222, 121.45806

45.83153, 1.25781

45.7009, 4.82511

46.58333, 0.33333

43.60426, 1.44367

51.45657, 7.01228

37.97945, 23.71622

40.85216, 14.26811

45.19205, 9.15917

41.89193, 12.51133

53.21917, 6.56667

50.84833, 5.68889

52.09083, 5.12222

41.45004, 2.24741

41.38879, 2.15899

41.38879, 2.15899

40.4165, -3.70256

42.81687, -1.64323

40.96882, -5.66388

52.6386, -1.13169

51.50853, -0.12574

40.44062, -79.99589

43.70011, -79.4163

36.09986, -80.24422

41.4995, -81.69541

51.05011, -114.08529

52.52437, 13.41053

49.40768, 8.69079

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5

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