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Corticosteroid
Lenalidomide + Dexamethasone + Elotuzumab with or without Cyclophosphamide for Primary Amyloidosis
Phase 2
Waitlist Available
Led By Jeffrey Zonder, M.D.
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the combination of lenalidomide, dexamethasone, and eotuzumab with or without cyclophosphamide to treat patients with primary amyloidosis that has come back after a period of improvement.
Eligible Conditions
- Primary Amyloidosis
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major hematologic response (>= very good partial response), or better
Secondary study objectives
Anti-drug antibody parameters
Complete response rate
Duration of hematologic response
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II(lenalidomide,dexamethasone,elotuzumab,cyclophosphamide)Experimental Treatment6 Interventions
Patients receive lenalidomide, dexamethasone, and elotuzumab as in Arm I. Patients also receive cyclophosphamide IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO on days 1-21 and dexamethasone IV on days 1, 8, 15, and 22. Patients also receive elotuzumab IV over 1 hour on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (lenalidomide, dexamethasone, elotuzumab)Experimental Treatment5 Interventions
Patients receive lenalidomide PO on days 1-21 and dexamethasone IV on days 1, 8, 15, and 22. Patients also receive elotuzumab IV over 1 hour on days 1, 8, 15, and 22 of courses 1 and 2 and days 1 and 15 of subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive lenalidomide PO on days 1-21 and dexamethasone IV on days 1, 8, 15, and 22. Patients also receive elotuzumab IV over 1 hour on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Elotuzumab
2016
Completed Phase 3
~910
Lenalidomide
2005
Completed Phase 3
~2240
Cyclophosphamide
2010
Completed Phase 4
~2310
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,124,931 Total Patients Enrolled
Barbara Ann Karmanos Cancer InstituteLead Sponsor
164 Previous Clinical Trials
9,195 Total Patients Enrolled
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,293 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot handle preventive blood clot medication.You had a stem cell transplant within the last 12 weeks.You have a specific level of free light chain concentration in your blood that shows a type of disease.You are expected to live for at least 6 months.Your alkaline phosphatase levels are not more than 5 times the upper limit of normal.Your platelet count is at least 75,000 cells per cubic millimeter.Your kidneys are working well enough, with a creatinine clearance of at least 30 mL/min.You are experiencing side effects from previous treatment that are not severe, except for hair loss and mild nerve-related symptoms without pain.You have severe numbness or pain in your hands or feet that hasn't improved with medicine in the past two weeks. If your previous severe numbness was helped by medicine like gabapentin, you might be able to join.You cannot tolerate steroid therapy.Your heart condition is at stage 2 or 3 and your NT-pro-BNP level is higher than 8500 ng/L.You have received one type of treatment before, such as specific chemotherapy or a stem cell transplant.Your hemoglobin level is at least 8.0 grams per deciliter.Your heart, kidneys, or liver show abnormal measurements or signs of damage related to amyloidosis.Your amyloidosis diagnosis needs to be confirmed through specific laboratory tests on tissue samples. If confirmation is not available, the case needs to be discussed with the study protocol chair.You have a serious heart condition, uncontrolled high blood pressure, or specific heart rhythm problems. Any abnormal heart test results must be confirmed by a doctor as not medically important before participating in the study.You have enough infection-fighting white blood cells in your body.You are able to perform daily activities without needing much help.You had a stem cell transplant within the last 16 weeks, or at any time if you have active graft-versus-host-disease.You have had a severe blood clotting problem in the last 6 months.Your total bilirubin level should be no more than 1.5 times the upper limit of normal, unless you have Gilbert's syndrome, in which case it can be no more than 2 times the upper limit of normal.Your AST and ALT levels in your blood are not more than three times the upper limit of normal.You have received certain types of cancer treatments within the last few weeks, or have been using corticosteroids for amyloidosis treatment.You have a specific type of amyloidosis caused by mutations in the transthyretin gene, or other non-AL amyloidosis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II(lenalidomide,dexamethasone,elotuzumab,cyclophosphamide)
- Group 2: Arm I (lenalidomide, dexamethasone, elotuzumab)
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.
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