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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
Must not have
- For participants with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization
Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >= 60 percent (%) plasma cells in the bone marrow, or hypercalcemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.4 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests if adding daratumumab to a standard treatment (CyBorD) helps newly diagnosed AL amyloidosis patients more than the standard treatment alone. Daratumumab boosts the immune system to attack harmful cells, while CyBorD fights the disease with a mix of medicines. Daratumumab has shown promising results in improving blood and organ responses in AL amyloidosis, leading to its integration into standard treatment regimens.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been hospitalized for heart failure issues in the last 4 weeks.
Select...
I have been diagnosed with multiple myeloma showing symptoms like bone damage or high calcium levels.
Select...
My heart failure is classified as severe or very severe.
Select...
I haven't been hospitalized for heart issues or had heart surgery in the last 6 months.
Select...
I have a history of serious heart rhythm problems but do not have a pacemaker or ICD, though I may need one.
Select...
My blood pressure is usually below 90 mmHg, or I get dizzy standing up despite treatment.
Select...
I have tested positive for hepatitis B or have had it in the past.
Select...
I experience mild numbness or mild pain in my hands or feet.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Overall Complete Hematologic Response (CHR)
Side effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613444%
Thrombocytopenia
38%
Peripheral sensory neuropathy
38%
Peripheral Sensory Neuropathy
32%
Anaemia
24%
Fatigue
22%
Diarrhoea
17%
Upper respiratory tract infection
17%
Upper Respiratory Tract Infection
16%
Constipation
15%
Insomnia
15%
Asthenia
13%
Cough
11%
Nausea
11%
Pyrexia
11%
Dizziness
11%
Neuralgia
10%
Back Pain
10%
Pneumonia
10%
Back pain
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Pain in extremity
7%
Hyperglycaemia
6%
Pain in Extremity
6%
Headache
6%
Paraesthesia
6%
Bronchitis
6%
Arthralgia
5%
Bone pain
5%
Bone Pain
5%
Decreased Appetite
5%
Hypocalcaemia
5%
Dyspepsia
5%
Leukopenia
5%
Hypokalaemia
5%
Decreased appetite
5%
Epistaxis
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Hypotension
4%
Abdominal pain
4%
Alanine aminotransferase increased
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Rash
3%
Hypertension
3%
Abdominal Pain Upper
3%
Abdominal pain upper
3%
Hypophosphataemia
3%
Influenza
3%
Conjunctivitis
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Muscle spasms
2%
Aspartate aminotransferase increased
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Urinary tract infection
2%
Herpes Zoster
1%
Weight decreased
1%
Pulmonary Embolism
1%
Pulmonary embolism
1%
Nasal congestion
1%
Weight Decreased
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Sepsis
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Condition aggravated
1%
General physical health deterioration
1%
Hyponatraemia
1%
Orthostatic hypotension
1%
Syncope
1%
Productive cough
1%
Lower respiratory tract infection
1%
Respiratory failure
1%
Chills
1%
Gastroenteritis
1%
Respiratory Failure
1%
Condition Aggravated
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bortezomib + Dexamethasone (Vd)
Daratumumab + Bortezomib and Dexamethasone (DVd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
Awards & Highlights
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.
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
~2380
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Amyloidosis, such as Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone, work through different mechanisms to target the disease. Daratumumab is a monoclonal antibody that targets CD38 on plasma cells, leading to their destruction.
Cyclophosphamide is an alkylating agent that interferes with DNA replication, causing cell death. Bortezomib is a proteasome inhibitor that disrupts protein degradation, leading to apoptosis of abnormal cells.
Dexamethasone is a corticosteroid that reduces inflammation and suppresses immune responses. These mechanisms are crucial for Amyloidosis patients as they help reduce the production of amyloid proteins, alleviate symptoms, and improve organ function, ultimately enhancing patient outcomes.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,401,954 Total Patients Enrolled
2 Trials studying Amyloidosis
330 Patients Enrolled for Amyloidosis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,979,981 Total Patients Enrolled
2 Trials studying Amyloidosis
330 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.