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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
Study 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major hematologic response (>= very good partial response), or better
Secondary outcome measures
Anti-drug antibody parameters
Complete response rate
Duration of hematologic response
+4 moreTrial 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
~2590
Elotuzumab
2016
Completed Phase 3
~800
Lenalidomide
2005
Completed Phase 3
~1480
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,461 Total Patients Enrolled
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,233 Total Patients Enrolled
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,305 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many distinct sites are overseeing the administration of this clinical trial?
"Levine Cancer Center in Charlotte, Emory Winship Cancer Institute in Atlanta and City of Hope Comprehensive Cancer Centre in Duarte are amongst the five participating sites. The other two locations have yet to be disclosed."
Answered by AI
Are there any open enrollment opportunities for this trial?
"As indicated on clinicaltrials.gov, this trial is not presently seeking participants; the last update was made in April 2022. However, there are 1,501 other trials currently available for enrolment."
Answered by AI
What therapeutic applications have been explored for Cyclophosphamide?
"Cyclophosphamide is usually prescribed to combat synovitis; however, it can be utilized in the treatment of ophthalmia, sympathetic pain, prior chemotherapy treatments and lung cancers."
Answered by AI
What is the maximum capacity for enrollees in this research program?
"This clinical trial is no longer open for enrolment. Initially posted on the 25th of August 2017, this study was updated lastly on 12th April 2022. If desired, there are 97 studies looking at amyloidosis and 1404 trials with cyclophosphamide that still require patients to join their research efforts."
Answered by AI
Are there any related research projects utilizing Cyclophosphamide?
"In 1997, the City of Hope Comprehensive Cancer Center initiated a study on cyclophosphamide. Since then, 2833 trials have concluded and 1404 are still ongoing; notably many in Charlotte, North carolina."
Answered by AI
What adverse effects should patients be cognizant of when taking Cyclophosphamide?
"Taking into account the fact that this is a Phase 2 trial, there are some evidence-based safety measures for Cyclophosphamide, thus giving it an estimation of 2. However, efficacy has yet to be verified through clinical data."
Answered by AI
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