AL Amyloidosis Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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:

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
Grade 2 sensory or Grade 1 painful peripheral neuropathy

Study is for people with:

AL Amyloidosis

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT05250973

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 45 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
Smilow Cancer Hospital/Yale Cancer Center
New Haven Connecticut, 06510, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute Emory University
Atlanta Georgia, 30322, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Boston University Medical Center
Boston Massachusetts, 02118, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Memorial Sloan Kettering
New York New York, 10021, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
University Hospital of Cleveland
Cleveland Ohio, 44106, United States
Ohio Health Research Institute
Columbus Ohio, 43214, United States
West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
VCU Medical Center
Richmond Virginia, 23219, United States
University of Washington
Seattle Washington, 90805, United States
Tom Baker Cancer Center
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
University Health Network UHN Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Peking University First Hospital
Beijing , 10003, China
Peking University People s Hospital
Beijing , 10004, China
West China Hospital Si Chuan University
Chengdu , 61004, China
First affiliated Hospital of Zhejiang University
Hangzhou , 31002, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai , 20002, China
CHU de Limoges
Limoges Cedex , 87042, France
Centre hospitalier Lyon-Sud
Pierre Benite cedex , 69495, France
CHU De Poitiers
Poitiers , 86000, France
CHU Rangueil
Toulouse , 31400, France
Charite Campus Benjamin Franklin
Berlin , 12203, Germany
Universitatsklinikum Essen
Essen , 45122, Germany
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg , 69120, Germany
Alexandra General Hospital of Athens
Athens , 11528, Greece
Università Degli Studi Di Napoli Federico Ii
Napoli , 80131, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
Roma , 00161, Italy
University Medical Center Groningen
Groningen , 9713 , Netherlands
Hospital Maastricht University Medical Center
Maastricht , 6229 , Netherlands
UMC Utrecht
Utrecht , 3584 , Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic de Barcelona
Barcelona , 08036, Spain
Clinica Univ. de Navarra
Madrid , 28027, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Leicester Royal Infirmary - Haematology
Leicester , LE1 5, United Kingdom
University College Hospital
London , NW1 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT05250973

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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