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Proteasome Inhibitor
Daratumumab + CyBorD for Amyloidosis
Phase 3
Waitlist Available
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
One or more organs impacted by AL amyloidosis according to consensus guidelines
Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.4 years
Awards & highlights
Study Summary
This trial is testing whether adding daratumumab to standard treatment for AL amyloidosis improves outcomes.
Who is the study for?
This trial is for adults with newly diagnosed systemic AL amyloidosis, which affects their organs. They must have measurable disease levels and be in a stable enough condition to participate (ECOG Performance Status 0-2). People can't join if they plan on having a stem cell transplant soon, have serious heart issues or infections like HIV or hepatitis B/C, severe neuropathy, or are being treated for multiple myeloma.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of adding Daratumumab to the CyBorD treatment regimen (Cyclophosphamide, Bortezomib, Dexamethasone) versus using CyBorD alone in patients who've just been diagnosed with AL amyloidosis.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, blood disorders like anemia and low platelets, nerve damage that could cause numbness or pain in hands and feet (neuropathy), increased risk of infection due to immune suppression by drugs used in treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AL amyloidosis has affected one or more of my organs.
Select...
My diagnosis of amyloidosis was confirmed through specific tissue staining and microscopy techniques.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
One of my organs is affected by AL amyloidosis.
Select...
I have AL amyloidosis with measurable disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Overall Complete Hematologic Response (CHR)
Side 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%
Pain in extremity
14%
Lymphopenia
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%
Bone pain
9%
Leukopenia
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Alanine aminotransferase increased
8%
Weight decreased
8%
Abdominal pain upper
8%
Muscle Spasms
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Abdominal pain
6%
Nasal congestion
6%
Aspartate aminotransferase increased
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%
Pleural effusion
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Femur fracture
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%
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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CyBorD plus DaratumumabExperimental Treatment1 Intervention
Participants will receive dexamethasone (20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.
Group II: CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)Active Control3 Interventions
Participants will receive dexamethasone (40 milligrams [mg] orally or intravenous [IV] dose), followed by cyclophosphamide (300 milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,892 Total Patients Enrolled
2 Trials studying Amyloidosis
320 Patients Enrolled for Amyloidosis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,489 Total Patients Enrolled
2 Trials studying Amyloidosis
320 Patients Enrolled for Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatment for AL amyloidosis or multiple myeloma, but not more than 160 mg dexamethasone.My AL amyloidosis has affected one or more of my organs.I have serious heart conditions.This criterion is incomplete. Can you please provide more information or context for clarity?You have a high amount of M-protein in your blood.I have not been hospitalized for heart failure issues in the last 4 weeks.I have been diagnosed with multiple myeloma showing symptoms like bone damage or high calcium levels.My diagnosis of amyloidosis was confirmed through specific tissue staining and microscopy techniques.My heart failure is classified as severe or very severe.I haven't been hospitalized for heart issues or had heart surgery in the last 6 months.My heart failure is due to a heart attack or valve disease, not AL amyloid cardiomyopathy.I have a history of serious heart rhythm problems but do not have a pacemaker or ICD, though I may need one.My blood pressure is usually below 90 mmHg, or I get dizzy standing up despite treatment.I have tested positive for hepatitis B or have had it in the past.I experience mild numbness or mild pain in my hands or feet.I can take care of myself and am up and about more than half of my waking hours.I am not planning a stem cell transplant within the first 6 treatment cycles, but collection is okay.One of my organs is affected by AL amyloidosis.You have tested positive for HIV.Your NT-ProBNP level is higher than 8500 ng/L.I have AL amyloidosis with measurable disease.Your baseline heart test shows a long QT interval, but if you have a pacemaker, you may still be able to participate.You have hepatitis C, unless you have been successfully treated for it.Your blood test shows abnormal levels of free light chains, and the difference between certain types of free light chains is too high.
Research Study Groups:
This trial has the following groups:- Group 1: CyBorD plus Daratumumab
- Group 2: CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is this study being conducted at multiple sites within the US?
"The study is based out of several locations, including the University of Pennsylvania Medical Center in Philadelphia, Pennsylvania and Mayo Clinic Arizona in Phoenix, Arizona. Including these two sites, a total of 35 clinical centres are participating."
Answered by AI
For what purpose is Daratumumab most often employed?
"Daratumumab is a medication used to treat synovitis, but it can also be effective against ophthalmia, sympathetic, and lung cancers as well as branch retinal vein occlusion."
Answered by AI
Does Daratumumab have a history of being successful in other medical trials?
"Daratumumab is being studied in 1411 ongoing clinical trials, with 283 of those studies classified as Phase 3. The global reach for these studies is impressive, with 44000 locations participating. That said, many of thePhase 3 studies are based in Philadelphia, Pennsylvania."
Answered by AI
What are the adverse effects of Daratumumab on patients?
"There is some evidence from earlier studies and rounds of testing that support the safety of Daratumumab, which our team has rated as a 3."
Answered by AI
How many total individuals are being observed in this clinical trial?
"As of now, this particular study is not looking for any more participants. The trial was initially posted on October 5th, 2017 and had its most recent update on November 3rd, 2022. However, there are 97 other clinical trials currently underway that are actively searching for patients with amyloidosis and 1411 studies involving Daratumumab that still need patients."
Answered by AI
Who else is applying?
What site did they apply to?
University of Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I've tried Vendemax and currently on Vendaqual. Unfortunately both have and are causing me diarrhea.
PatientReceived 2+ prior treatments
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