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Isatuximab + Lenalidomide for Multiple Myeloma (HEME-18 Trial)
Phase 2
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0, 1, or 2 within 30 days prior to enrollment
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
HEME-18 Trial Summary
This trialtests if isatuximab & lenalidomide post-ASCT can help cancer patients maintain a positive response to treatment.
Who is the study for?
Adults over 18 with confirmed multiple myeloma, who've had less than two prior therapies and are planning or have recently completed an Autologous Stem Cell Transplant (ASCT). They must be MRD-positive post-ASCT, able to take oral meds, agree to contraception use, and not have certain health conditions that could interfere with the trial.Check my eligibility
What is being tested?
The study is testing maintenance therapy using Isatuximab and Lenalidomide in patients who still show minimal residual disease after ASCT. It's a phase II trial aiming to see how effective this combination is for keeping the cancer at bay.See study design
What are the potential side effects?
Possible side effects of Isatuximab include infusion reactions like fever or chills, low blood counts increasing infection risk, tiredness, nausea. Lenalidomide may cause birth defects if taken during pregnancy; other risks include blood clots and decreased blood cell counts.
HEME-18 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've been mostly active and able to care for myself in the last 30 days.
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I am older than 18 years.
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My cancer responded to initial treatment and stem cell transplant.
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I can get lenalidomide for the study when I enroll.
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I have been diagnosed with multiple myeloma, not just a less active form or plasma cell leukemia.
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I am planning to have or have had a stem cell transplant within the last 6 months and haven't started maintenance therapy.
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I can swallow pills and don't have major stomach or bowel issues.
HEME-18 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants that have MRD-negative CR rate, defined as 10-5
Secondary outcome measures
Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance
Number of occurrences of treatment-related adverse events (AE) in MM patients receiving isatuximab and lenalidomide based maintenance
Number of participants that achieve a deeper MRD-negative CR rate, defined as 10-6
+5 moreHEME-18 Trial Design
1Treatment groups
Experimental Treatment
Group I: Isatuximab and Lenalidomide MaintenanceExperimental Treatment2 Interventions
All participants will receive:
Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39. Lenalidomide 10mg PO Days 1-21 Cylces 1-3 (all cycles 28 days) Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
FDA approved
Lenalidomide
FDA approved
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
609 Previous Clinical Trials
1,559,259 Total Patients Enrolled
4 Trials studying Multiple Myeloma
165 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been mostly active and able to care for myself in the last 30 days.I am older than 18 years.My multiple myeloma has spread to my brain or spinal cord.My organs are functioning well according to recent tests.I have hepatitis C with a known viral load.I am scheduled for a stem cell transplant as part of my initial multiple myeloma treatment.My cancer responded to initial treatment and stem cell transplant.You have no detectable cancer cells in your body at a very sensitive level.I have had an organ transplant and am on immunosuppressive drugs.I have had a stem cell transplant from a donor.I can get lenalidomide for the study when I enroll.I've had 2 or fewer treatments before stem cell transplant and am not resistant to specific antibody or lenalidomide therapies.I have been diagnosed with multiple myeloma, not just a less active form or plasma cell leukemia.I have another cancer that is growing and needs treatment.My multiple myeloma was stage 1, 2, or 3 at diagnosis, or I plan to have maintenance therapy after stem cell transplant.I am planning to have or have had a stem cell transplant within the last 6 months and haven't started maintenance therapy.I do not have any severe illnesses or heart problems that are not under control.I have had a bad reaction to isatuximab or lenalidomide.My condition did not improve after treatment with anti-CD38 or lenalidomide.I can swallow pills and don't have major stomach or bowel issues.You have tested positive for HIV or have been diagnosed with AIDS.I have an active hepatitis B infection.
Research Study Groups:
This trial has the following groups:- Group 1: Isatuximab and Lenalidomide Maintenance
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 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.
- 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.
What is the projected scale of this research project?
"That is correct. The listing for this study on clinicaltrials.gov says that it is recruiting patients. This trial was originally posted on December 1st, 2020 and updated November 15th, 2020. They are looking for 50 participants from a single site."
Answered by AI
Are there any life-threatening risks associated with Isatuximab and Lenalidomide Maintenance?
"Isatuximab and Lenalidomide Maintenance is currently in Phase 2 of clinical trials. While there is some safety data, none exists for efficacy. Our team ranks it as a 2."
Answered by AI
Are patients currently being signed up for this experiment?
"The listing on clinicaltrials.gov verifies that this study is currently enrolling patients. This trial was initially posted on December 1st, 2020 and last updated November 15th, 2020. The study requires 50 participants at a single site."
Answered by AI
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