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

Primary Purpose

Amyloidosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Daratumumab
Cyclophosphamide
Bortezomib
Dexamethasone
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 per International Myeloma Working Group (IMWG) Criteria

  • 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

Sites / Locations

  • City of HopeRecruiting
  • Moffitt Cancer CenterRecruiting
  • Tufts Medical CenterRecruiting
  • Boston University Medical CenterRecruiting
  • Barbara Ann Karmanos Cancer InstituteRecruiting
  • Memorial Sloan KetteringRecruiting
  • University Hospital of ClevelandRecruiting
  • The Ohio State UniversityRecruiting
  • West Penn HospitalRecruiting
  • University of WashingtonRecruiting
  • Tom Baker Cancer CenterRecruiting
  • University Health Network (UHN) Princess Margaret Cancer CentreRecruiting
  • Peking University First HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • West China Hospital, Si Chuan UniversityRecruiting
  • First affiliated Hospital of Zhejiang UniversityRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong UniversityRecruiting
  • CHU de LimogesRecruiting
  • Centre hospitalier Lyon-SudRecruiting
  • CHU De PoitiersRecruiting
  • CHU RangueilRecruiting
  • Charite Campus Benjamin FranklinRecruiting
  • Universitatsklinikum EssenRecruiting
  • Universitaetsklinikum Heidelberg Medizinische Klinik VRecruiting
  • Alexandra General Hospital of AthensRecruiting
  • Università Degli Studi Di Napoli Federico IiRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''Recruiting
  • University Medical Center GroningenRecruiting
  • Hospital Maastricht University Medical CenterRecruiting
  • UMC UtrechtRecruiting
  • Hosp. Univ. Germans Trias I PujolRecruiting
  • Hosp. Univ. Vall D HebronRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Clinico Univ. de SalamancaRecruiting
  • Leicester Royal Infirmary - HaematologyRecruiting
  • University College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort1 (Arm A): Immediate Daratumumab + Cyclophosphamide, Bortezomib and Dexamethasone (VCd)

Cohort1 (Arm B): Daratumumab + Deferred VCd

Cohort 2: Daratumumab + VCd

Arm Description

Participants with newly diagnosed systemic amyloid light chain (AL) amyloidosis with Mayo Cardiac Stage II and IIIa cardiac involvement will receive daratumumab 1800 milligrams (mg) subcutaneously (SC) starting on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (cyclophosphamide 300 milligrams per meter square [mg/m^2] either orally or intravenously [IV], bortezomib 1.3 mg/m^2 SC, dexamethasone 40 mg weekly either orally or IV) weekly starting at Cycle 1 Day 1 up to Day 22 in every 28-day cycle for a maximum of 6 cycles (Cycle 6 Day 22).

Participants with newly diagnosed systemic AL amyloidosis with Mayo Cardiac Stage II and IIIa cardiac involvement will receive SC daratumumab 1800mg on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (Cyclophosphamide 300 mg/m^2 either orally or IV, Bortezomib 1.3 mg/m^2 SC, Dexamethasone 40 mg weekly either orally or IV) starting at Cycle 4 Day 1, weekly (Days 1, 8, 15, 22) in every 28-day cycle for a maximum of 6 cycles (Cycle 9 Day 22).

Participants with racial and ethnic minorities, including Black or African American participants, with newly diagnosed AL amyloidosis will receive SC injection of daratumumab 1800 mg SC on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (cyclophosphamide 300 milligrams per meter square [mg/m^2] either orally or intravenously [IV], bortezomib 1.3 mg/m^2 SC, dexamethasone 40 mg weekly either orally or IV) weekly starting at Cycle 1 Day 1 up to Day 22 in every 28-day cycle for a maximum of 6 cycles (Cycle 6 Day 22).

Outcomes

Primary Outcome Measures

Number of Participants with Cardiac Events of Any Toxicity Grade
Number of participants with cardiac events of any toxicity grade will be reported.
Observed Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough)
Ctrough is defined as the observed concentration immediately prior to the next study treatment administration.

Secondary Outcome Measures

Overall Complete Hematologic Response (HemCR) Rate
Overall HemCR rate is defined as percentage of participants who achieve HemCR during or after the study treatment.
HemCR Rate
HemCR rate at 6 month is defined as percentage of participants who achieve HemCR at 6 month during or after the study treatment.
Very Good Partial Response (VGPR) or Better Rate
Hematologic greater than or equal to (>=) VGPR rate is defined as percentage of participants who achieve hematologic response of VGPR or better.
Time to HemCR or (VGPR or Better)
For participants who achieve HemCR (or >=VGPR), time to HemCR (or >=VGPR) is defined as the time between the date of randomization (Cohort1)/first treatment (Cohort 2) and the first efficacy evaluation at which the participant has met all criteria for hematologic complete response (CR) (or >=VGPR).
Duration of Response (HemCR and VGPR or Better)
For participants who achieve HemCR (or >=VGPR), duration of HemCR (or >=VGPR) is defined as the time between the date of initial documentation of HemCR (or >=VGPR) to the date of first documented evidence of hematologic progressive disease or death, whichever comes first.
Organ Response Rate (OrRR)
Organ response rate is defined as the percentage of participants who achieve organ response in each corresponding organ (kidney, heart, liver).
Overall Survival (OS)
OS is measured from the date of randomization (Cohort 1)/first treatment (Cohort 2) to the date of the participant's death.
Time to Next Treatment (TNT)
TNT for amyloid light chain (AL) amyloidosis is defined as the time from the date of randomization (Cohort1)/first treatment (Cohort 2) to the start date of subsequent AL amyloidosis (non-protocol) treatment.
Number of Participants with Adverse Events (AEs) by Severity
Number of participants with AEs by severity will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Serum Concentration of Daratumumab
Serum samples will be analyzed to determine concentrations of daratumumab.
Number of Participants with Antibodies to Daratumumab
Number of participants with antibodies to daratumumab will be reported.
Number of Participants with Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Number of participants with antibodies to rHuPH20 will be reported.
Change from Baseline in Clinical Signs and Symptoms Score of Cardiac AL Amyloidosis
Change from baseline in clinical signs and symptoms score of cardiac AL amyloidosis will be reported.

Full Information

First Posted
February 11, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05250973
Brief Title
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Acronym
AQUARIUS
Official Title
A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 29, 2024 (Anticipated)
Study Completion Date
November 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + 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).
Detailed Description
AL amyloidosis is a rare disorder caused by clonal plasma cells that secrete immunoglobulin light chains that misfold into insoluble amyloid. The insoluble amyloid gets deposited in vital organs which results in serious and life-threatening organ dysfunction. Daratumumab is a human immunoglobulin (IgG1K) monoclonal antibody (mAb) that binds with high affinity to a unique epitope on cluster of differentiation 38 (CD38), a transmembrane glycoprotein. It is a targeted immunotherapy directed towards tumor cells that overexpress CD38. Participants will be enrolled into 2 cohorts based on cardiac involvement at baseline for cohort 1 and racial or ethnic minority with at least one organ involved for cohort 2. This study aims to generate data on risk factors for cardiac toxicity and to evaluate the cardiac safety of the proposed treatment regimens and identify potential mitigation strategies for cardiac toxicity such as deferred VCd treatment, The study will consist of screening phase (up to 28 days) and treatment phase with up to 24 treatment cycles (each cycle is 28 days). Safety assessment will include adverse events (AEs), serious adverse events (SAEs), physical examinations, Eastern Cooperative Oncology Group (ECOG) criteria for performance status, laboratory tests and vital signs. The overall duration of the study will be up to 3 years and 8 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort1 (Arm A): Immediate Daratumumab + Cyclophosphamide, Bortezomib and Dexamethasone (VCd)
Arm Type
Experimental
Arm Description
Participants with newly diagnosed systemic amyloid light chain (AL) amyloidosis with Mayo Cardiac Stage II and IIIa cardiac involvement will receive daratumumab 1800 milligrams (mg) subcutaneously (SC) starting on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (cyclophosphamide 300 milligrams per meter square [mg/m^2] either orally or intravenously [IV], bortezomib 1.3 mg/m^2 SC, dexamethasone 40 mg weekly either orally or IV) weekly starting at Cycle 1 Day 1 up to Day 22 in every 28-day cycle for a maximum of 6 cycles (Cycle 6 Day 22).
Arm Title
Cohort1 (Arm B): Daratumumab + Deferred VCd
Arm Type
Experimental
Arm Description
Participants with newly diagnosed systemic AL amyloidosis with Mayo Cardiac Stage II and IIIa cardiac involvement will receive SC daratumumab 1800mg on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (Cyclophosphamide 300 mg/m^2 either orally or IV, Bortezomib 1.3 mg/m^2 SC, Dexamethasone 40 mg weekly either orally or IV) starting at Cycle 4 Day 1, weekly (Days 1, 8, 15, 22) in every 28-day cycle for a maximum of 6 cycles (Cycle 9 Day 22).
Arm Title
Cohort 2: Daratumumab + VCd
Arm Type
Experimental
Arm Description
Participants with racial and ethnic minorities, including Black or African American participants, with newly diagnosed AL amyloidosis will receive SC injection of daratumumab 1800 mg SC on Day 1 once weekly (q1w) up to Day 22 for cycles 1-2, on Days 1 and 15 for cycles 3-6, and on Day 1 for cycles 7-24 of a 28-day cycle. Participants will also receive VCd (cyclophosphamide 300 milligrams per meter square [mg/m^2] either orally or intravenously [IV], bortezomib 1.3 mg/m^2 SC, dexamethasone 40 mg weekly either orally or IV) weekly starting at Cycle 1 Day 1 up to Day 22 in every 28-day cycle for a maximum of 6 cycles (Cycle 6 Day 22).
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
JNJ-54767414
Intervention Description
Daratumumab will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide will be administered either orally or IV.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib will be administered by SC injection.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered orally or IV.
Primary Outcome Measure Information:
Title
Number of Participants with Cardiac Events of Any Toxicity Grade
Description
Number of participants with cardiac events of any toxicity grade will be reported.
Time Frame
Up to 12 months
Title
Observed Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough)
Description
Ctrough is defined as the observed concentration immediately prior to the next study treatment administration.
Time Frame
Cycle 3 Day 1 predose (each cycle is of 28 days)
Secondary Outcome Measure Information:
Title
Overall Complete Hematologic Response (HemCR) Rate
Description
Overall HemCR rate is defined as percentage of participants who achieve HemCR during or after the study treatment.
Time Frame
Up to 3 years
Title
HemCR Rate
Description
HemCR rate at 6 month is defined as percentage of participants who achieve HemCR at 6 month during or after the study treatment.
Time Frame
At 6 months
Title
Very Good Partial Response (VGPR) or Better Rate
Description
Hematologic greater than or equal to (>=) VGPR rate is defined as percentage of participants who achieve hematologic response of VGPR or better.
Time Frame
Up to 3 Years
Title
Time to HemCR or (VGPR or Better)
Description
For participants who achieve HemCR (or >=VGPR), time to HemCR (or >=VGPR) is defined as the time between the date of randomization (Cohort1)/first treatment (Cohort 2) and the first efficacy evaluation at which the participant has met all criteria for hematologic complete response (CR) (or >=VGPR).
Time Frame
Up to 3 years
Title
Duration of Response (HemCR and VGPR or Better)
Description
For participants who achieve HemCR (or >=VGPR), duration of HemCR (or >=VGPR) is defined as the time between the date of initial documentation of HemCR (or >=VGPR) to the date of first documented evidence of hematologic progressive disease or death, whichever comes first.
Time Frame
Up to 3 years
Title
Organ Response Rate (OrRR)
Description
Organ response rate is defined as the percentage of participants who achieve organ response in each corresponding organ (kidney, heart, liver).
Time Frame
Up to 3 years
Title
Overall Survival (OS)
Description
OS is measured from the date of randomization (Cohort 1)/first treatment (Cohort 2) to the date of the participant's death.
Time Frame
Up to 3 years
Title
Time to Next Treatment (TNT)
Description
TNT for amyloid light chain (AL) amyloidosis is defined as the time from the date of randomization (Cohort1)/first treatment (Cohort 2) to the start date of subsequent AL amyloidosis (non-protocol) treatment.
Time Frame
Up to 3 Years
Title
Number of Participants with Adverse Events (AEs) by Severity
Description
Number of participants with AEs by severity will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time Frame
Up to 3 Years
Title
Serum Concentration of Daratumumab
Description
Serum samples will be analyzed to determine concentrations of daratumumab.
Time Frame
Up to 3 Years
Title
Number of Participants with Antibodies to Daratumumab
Description
Number of participants with antibodies to daratumumab will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Description
Number of participants with antibodies to rHuPH20 will be reported.
Time Frame
Up to 3 years
Title
Change from Baseline in Clinical Signs and Symptoms Score of Cardiac AL Amyloidosis
Description
Change from baseline in clinical signs and symptoms score of cardiac AL amyloidosis will be reported.
Time Frame
Baseline up to 3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 per International Myeloma Working Group (IMWG) Criteria 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospital of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Recruiting
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Health Network (UHN) Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Si Chuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
First affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310020
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
CHU de Limoges
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Name
Centre hospitalier Lyon-Sud
City
Pierre Benite cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
CHU De Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Heidelberg Medizinische Klinik V
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Università Degli Studi Di Napoli Federico Ii
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hospital Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Leicester Royal Infirmary - Haematology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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