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Proteasome Inhibitor
Daratumumab Combination Therapy for Amyloidosis (AQUARIUS Trial)
Phase 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
Cohort 1: Cardiac involvement (amyloid light chain [AL] amyloidosis Mayo Cardiac Stage II and Stage IIIa) with or without other organ(s) involved
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
AQUARIUS Trial Summary
This trial is testing a new cancer treatment to see if it is safe for people with heart problems. The new treatment is a combination of drugs, and the trial will also look at how well it works in people of different racial and ethnic backgrounds.
Who is the study for?
This trial is for adults with newly diagnosed AL amyloidosis affecting the heart and possibly other organs. Participants should be able to perform light activities (ECOG score 0-2). Women must test negative for pregnancy and agree to regular tests; men must not donate sperm during and after the study. Racial/ethnic minorities, including Black or African American individuals, are specifically included in one cohort.Check my eligibility
What is being tested?
The trial studies Daratumumab-based therapies in two groups: one receives immediate treatment with Daratumumab combined with Cyclophosphamide, Bortezomib, Dexamethasone (D-VCd), while the other has deferred VCd treatment. It aims to assess cardiac safety and understand how different populations process the drug.See study design
What are the potential side effects?
Potential side effects include reactions at injection sites, heart complications, blood disorders like low counts of various cells leading to increased infection risk or bleeding tendencies, nerve damage that could cause numbness or pain, muscle weakness, and possible harm to unborn babies.
AQUARIUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My heart is affected by AL amyloidosis, at Stage II or IIIa.
AQUARIUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Cardiac Events of Any Toxicity Grade
Observed Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough)
Secondary outcome measures
Change from Baseline in Clinical Signs and Symptoms Score of Cardiac AL Amyloidosis
Duration of Response (HemCR and VGPR or Better)
HemCR Rate
+10 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Nasal congestion
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Gastroenteritis
1%
Femur fracture
1%
Pleural effusion
1%
Pathological fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
AQUARIUS Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort1 (Arm B): Daratumumab + Deferred VCdExperimental Treatment4 Interventions
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).
Group II: Cohort1 (Arm A): Immediate Daratumumab + Cyclophosphamide, Bortezomib and Dexamethasone (VCd)Experimental Treatment4 Interventions
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).
Group III: Cohort 2: Daratumumab + VCdExperimental Treatment4 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 2
~1140
Dexamethasone
2007
Completed Phase 4
~2590
Daratumumab
2014
Completed Phase 3
~1860
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,158 Total Patients Enrolled
2 Trials studying Amyloidosis
586 Patients Enrolled for Amyloidosis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,755 Total Patients Enrolled
2 Trials studying Amyloidosis
586 Patients Enrolled for Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used any experimental drugs or devices, or had certain vaccines recently.I am not planning a stem cell transplant within the first 9 treatment cycles, but collection is okay.I can take care of myself and am up and about more than half of my waking hours.One of my organs is affected by AL amyloidosis.I am a woman who can have children, have tested negative for pregnancy, and agree to ongoing pregnancy tests.I agree not to donate sperm during and up to 6 months after the study.My heart is affected by AL amyloidosis, at Stage II or IIIa.I have had treatment for AL amyloidosis or multiple myeloma, but not more than 160mg dexamethasone.I experience mild numbness or mild pain in my hands or feet.I have been diagnosed with symptomatic multiple myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort1 (Arm B): Daratumumab + Deferred VCd
- Group 2: Cohort1 (Arm A): Immediate Daratumumab + Cyclophosphamide, Bortezomib and Dexamethasone (VCd)
- Group 3: Cohort 2: Daratumumab + VCd
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there multiple locations in the U.S. facilitating this medical study?
"The list of participating medical centres includes Houston Methodist Cancer Center, University Health Network (UHN) Princess Margaret Cancer Centre, and Tom Baker Cancer Center. Additionally, 15 other institutions have been enlisted to support this clinical trial."
Answered by AI
Has Daratumumab acquired authorization from the FDA?
"Our team at Power believes that daratumumab is a safe drug, granting it an evaluation of 2. This assessment takes into account the fact that this medication has been evaluated in Phase 2 trials and demonstrates signs of safety but no evidence for efficacy."
Answered by AI
Are there any available slots in this investigation for participants?
"Affirmative. Clinicaltrials.gov records indicate that recruitment for this clinical trial is still ongoing, with the initial posting dated March 1st 2022 and most recent edit on November 3rd 2022. The research team seeks 150 participants to be recruited from 18 sites altogether."
Answered by AI
What is the sample size of this investigation?
"Yes, per the clinicaltrials.gov listing, this clinical trial is actively seeking enrolment from 150 patients across 18 separate medical sites. The initial posting was made on March 1st 2022 and latest update took place November 3rd 2022."
Answered by AI
In what ways is this study attempting to advance medicine?
"The primary outcome of this trial will be evaluated over a 12-month period and is referred to as Observed Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough). Secondary endpoints are Overall Survival (OS) determined from the date of randomization/first treatment, Very Good Partial Response (VGPR) or Better Rate defined by hematologic response greater than VGPR, and an Overall Complete Hematologic Response (HemCR) rate."
Answered by AI
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