Your session is about to expire
← Back to Search
Corticosteroid
Quadruple Therapy for Multiple Myeloma (IMPEDE Trial)
Phase 2
Recruiting
Led By Binod Dhakal, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects who are postmenopausal for at least one year before the screening visit, or are surgically sterile
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 3
Awards & highlights
IMPEDE Trial Summary
This trial is testing a new treatment for multiple myeloma that has relapsed or become refractory to other treatments. It consists of three phases: screening, treatment, and follow-up.
Who is the study for?
Adults with multiple myeloma who've had at least two prior treatments, including lenalidomide and a proteasome inhibitor, can join this trial. They must have measurable disease, be in good enough health to perform daily activities (ECOG 0-2), and use effective contraception. Those allergic to similar drugs or with certain heart, lung conditions or other cancers cannot participate.Check my eligibility
What is being tested?
The study tests a combination of isatuximab, pomalidomide, elotuzumab, and dexamethasone in patients whose multiple myeloma has returned after treatment. It's an open-label phase II trial where everyone gets the same drugs in repeated 28-day cycles after screening.See study design
What are the potential side effects?
Possible side effects include immune system reactions that might cause fever or chills during infusion; blood clots; low blood counts leading to increased infection risk; fatigue; nausea; diarrhea; and potential nerve damage causing numbness or pain.
IMPEDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who has been postmenopausal for at least a year or am surgically sterile.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
I have multiple myeloma and have tried at least 2 treatments including lenalidomide and a proteasome inhibitor, but they didn’t work.
IMPEDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
IMPEDE Trial Design
2Treatment groups
Experimental Treatment
Group I: Safety Run-inExperimental Treatment4 Interventions
Six subjects will be enrolled. Isatuximab (10 mg/kg) intravenous (IV) on days 2, 8, 15, 22 of cycle 2 and days 1 and 15 of subsequent cycles. Pomalidomide (4 mg) by mouth (PO) days 1-21 of each cycle. Elotuzumab (10 mg/kg) on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles. Dexamethasone 40 mg (20 mg if >75 years) PO or IV on days 1, 8,15 and 22 of each cycle.
Group II: ExpansionExperimental Treatment4 Interventions
Forty-seven subjects with relapsed and/or refractory multiple myeloma will be enrolled.
Isatuximab (10 mg/kg) IV on days 2, 8, 15, 22 of cycle 1 and days 1 and 15 of subsequent cycles. Pomalidomide (4 mg) PO days 1-21 of each cycle. Elotuzumab (10 mg/kg) on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles. Dexamethasone 40 mg (20 mg if >75 years) PO or IV on days 1, 8,15 and 22 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elotuzumab
2016
Completed Phase 3
~800
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,660 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,673 Patients Enrolled for Multiple Myeloma
Binod Dhakal, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
71 Total Patients Enrolled
3 Trials studying Multiple Myeloma
71 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition did not improve after treatment with SLAMF7 antibody.You have allergies or bad reactions to monoclonal antibodies or human proteins.I have been diagnosed with a specific blood disorder.I have been diagnosed with chronic obstructive pulmonary disease.My bone marrow, liver, and kidney functions are not normal.I have had severe asthma in the last 2 years or currently have uncontrolled asthma.I agree to use effective contraception or practice abstinence during and for four months after the study.You are planning to have a child.My condition did not improve or worsened with pomalidomide treatment.I had major surgery less than 2 weeks ago or haven't recovered from it, or I plan to have surgery during the study.You have HIV, hepatitis B, or active hepatitis C.I will use effective birth control from two weeks before until 16 weeks after my last dose of the study drug.I am a woman who has been postmenopausal for at least a year or am surgically sterile.I have a serious heart condition.I had a CD38 antibody treatment over 6 months ago and saw some improvement.I can take care of myself and am up and about more than half of the day.I am 18 years old or older.My multiple myeloma has affected my brain or spinal cord.You have certain levels of proteins in your blood or urine that indicate the presence of multiple myeloma.I have been diagnosed or treated for cancer other than multiple myeloma, with some exceptions.I am a woman who can have children and have a negative pregnancy test.I have multiple myeloma and have tried at least 2 treatments including lenalidomide and a proteasome inhibitor, but they didn’t work.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-in
- Group 2: Expansion
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.
What is the primary purpose that Isatuximab is used for?
"Isatuximab can be used to treat certain eye conditions such as ophthalmia, sympathetic, branch retinal vein occlusion, and macular edema (during the run-in period)."
Answered by AI
What is the regulatory body's stance on Isatuximab (for run-in portion)?
"Isatuximab (for run-in portion) falls into Phase 2 of medical trials. This means that while there is clinical data supporting its safety, there is none yet affirming its efficacy. Therefore, our team has given it a score of 2."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger