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Monoclonal Antibodies
Daratumumab + Ixazomib + Dexamethasone for Amyloidosis
Phase 1
Waitlist Available
Led By Hans C Lee
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male patients agreeing to specific contraceptive measures
Diagnosis of primary systemic AL amyloidosis confirmed by Congo red staining of tissue showing apple green birefringence and clonal plasma cell disorder demonstrated by immunohistochemistry, in situ hybridization, or flow cytometry on bone marrow biopsy, or monoclonal protein on serum or urine electrophoresis/immunofixation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of daratumumab, ixazomib, and dexamethasone in treating patients with amyloid light chain amyloidosis.
Who is the study for?
This trial is for adults with AL amyloidosis, a condition where abnormal proteins build up in organs. Participants must have an acceptable level of organ function and performance status, not be pregnant or breastfeeding, and agree to use contraception. Those with severe infections, recent major surgeries or treatments, certain other cancers within the last 2 years, or specific heart diseases cannot join.Check my eligibility
What is being tested?
The study tests the combination of daratumumab (a monoclonal antibody), ixazomib (chemotherapy), and dexamethasone (a steroid) to treat AL amyloidosis. It aims to find the safest doses and see how well they work together against this disease by stopping tumor cells from growing.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to daratumumab, chemotherapy-related issues like nausea and hair loss from ixazomib, as well as possible increased infection risk and blood sugar changes due to dexamethasone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use contraception as required.
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I have been diagnosed with AL amyloidosis confirmed by specific tests.
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My platelet count is at least 75,000 without recent transfusions.
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My kidneys are functioning well enough to clear waste.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity rate
Recommended phase 2 dose of daratumumab, ixazomib, and dexamethasone
Secondary outcome measures
Duration of response
Overall hematologic response rate
Overall survival
+3 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab, ixazomib, dexamethasone)Experimental Treatment3 Interventions
Participants receive daratumumab IV over 3.5-6.5 hours on days 1, 8, 15, and 22 of courses 1-2, on days 1 and 15 of courses 3-6, and on day 1 of courses 7-12. Participants also receive ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unaccepted toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Daratumumab
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
205,050 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,241 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,781 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is not light-chain (AL) amyloidosis.My lung function is severely reduced, with less than half the normal airflow.I agree to use contraception as required.I haven't had radiotherapy in the last 2 weeks, or last week if it was a small area.I haven't taken strong CYP3A inducers, Ginkgo biloba, or St. John's wort in the last 14 days.I have a GI condition that may affect medication absorption.I am a woman who is postmenopausal, surgically sterile, or agrees to use contraception.I still have side effects from my last chemotherapy.I do not have any serious health or mental conditions that could stop me from completing treatment.I have severe nerve pain or numbness in my hands or feet.I have been diagnosed with AL amyloidosis confirmed by specific tests.I have newly diagnosed or relapsed AL amyloidosis, possibly with previous treatments.My platelet count is at least 75,000 without recent transfusions.My kidneys are functioning well enough to clear waste.I do not have serious heart problems.I have not had major surgery in the last 2 weeks.You have enough infection-fighting white blood cells.I have been treated with daratumumab or ixazomib, or was in a study with ixazomib.My condition is diagnosed as active myeloma.I do not have an active infection, hepatitis B or C, or HIV.I am not pregnant or breastfeeding.Your liver enzyme levels (ALT and AST) are not more than 3 times the upper limit of normal.I am able to care for myself and perform daily activities.I haven't needed IV antibiotics for an infection in the last 14 days.Your total bilirubin level is not more than 1.5 times the upper limit of the normal range.I haven't had or been treated for another cancer within the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (daratumumab, ixazomib, dexamethasone)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
How reliable is Dexamethasone when it comes to patient safety?
"The safety of Dexamethasone is tentatively rated a 1 since this phase 1 trial has limited data in regard to efficacy and security."
Answered by AI
What therapeutic uses is Dexamethasone typically employed for?
"Dexamethasone is a commonly used medication for treating ophthalmia and sympathetic. It may also be effective in relieving symptoms associated with branch retinal vein occlusion, macular edema, communicable diseases."
Answered by AI
How many persons are enrolled in this clinical experiment?
"Affirmative, the clinicaltrials.gov database reveals that this trial is actively recruiting and was first advertised on February 7th 2018. As of September 21st 2022, 20 volunteers are necessary across 1 site."
Answered by AI
Is there any historical precedent for employing Dexamethasone in clinical research?
"Presently, a total of 628 studies are underway exploring the effects of Dexamethasone. 152 of these active trials have reached Phase 3 and Mishawaka, Indiana is hosting the bulk of them; however there exist 20766 sites conducting research on this medication."
Answered by AI
Are there any vacancies within this clinical research project?
"Affirmative, the clinicaltrials.gov database displays that this trial is currently enrolling participants. It was first publicized on February 7th 2018 and most recently modified on September 21st 2022. The research requires a total of 20 recruits from 1 medical center to complete the study."
Answered by AI
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