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

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

Last Updated February 21, 2025

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CR109160

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2

2
Sites
45 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:

More...

DETAILS

LOCATIONS

Locations in:

United States, Canada, China, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom

Country (10)	City or Province (45)	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	Cleveland University Hospital of Cleveland	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	Calgary Tom Baker Cancer 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	Berlin Charite Campus Benjamin Franklin	RECRUITING
Germany	Essen Universitatsklinikum Essen	COMPLETED
Germany	Heidelberg Universitaetsklinikum Heidelberg Medizinische Klinik V	RECRUITING
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

Geo Locations

34.13945, -117.97729

41.30815, -72.92816

27.94752, -82.45843

33.749, -84.38798

42.35843, -71.05977

42.33143, -83.04575

40.71427, -74.00597

35.22709, -80.84313

41.4995, -81.69541

39.96118, -82.99879

32.78306, -96.80667

37.55376, -77.46026

47.60621, -122.33207

51.05011, -114.08529

53.55014, -113.46871

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

52.52437, 13.41053

51.45657, 7.01228

49.40768, 8.69079

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

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

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

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

41.4995, -81.69541

39.96118, -82.99879

32.78306, -96.80667

37.55376, -77.46026

47.60621, -122.33207

51.05011, -114.08529

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

52.52437, 13.41053

51.45657, 7.01228

49.40768, 8.69079

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

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