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Corticosteroid
Triple Therapy for Multiple Myeloma (EMAT Trial)
Phase 2
Recruiting
Led By Meera Mohan, 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
Age ≥18 years
Presence of residual bone marrow minimal residual disease (MRD) positivity by clonoSEQ® next-generation sequencing (NGS) 90-120 days post autologous stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
EMAT Trial Summary
This trial tests a new treatment for multiple myeloma patients who still have signs of the disease after stem cell transplant.
Who is the study for?
This trial is for adults over 18 with multiple myeloma who still have cancer cells in their bone marrow after a stem cell transplant. They must be able to give consent, not be pregnant or breastfeeding, and can't join if they've had recent major surgery, active infections, other cancers needing treatment, severe heart conditions, known allergies to study drugs or certain components of them.Check my eligibility
What is being tested?
The study tests Dexamethasone, Lenalidomide, and Isatuximab on patients with minimal residual disease post-transplant. It's a phase II trial at one center where all participants receive the same treatment without comparison groups.See study design
What are the potential side effects?
Possible side effects include weakened immune system leading to increased infection risk; blood sugar increases; mood swings; insomnia from Dexamethasone; diarrhea; fatigue; rash from Lenalidomide; infusion reactions like fever or chills and potential heart rhythm problems from Isatuximab.
EMAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My bone marrow test shows cancer cells after a stem cell transplant.
Select...
I am able to get out of my bed or chair and move around.
Select...
I had a stem cell transplant within a year of being diagnosed with myeloma.
EMAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of subjects who have less than MRD.
EMAT Trial Design
1Treatment groups
Experimental Treatment
Group I: Isatuximab in combination with lenalidomide and dexamethasone.Experimental Treatment3 Interventions
The isatuximab, lenalidomide, and dexamethasone (IsaRD) therapy will be administered on an outpatient basis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Isatuximab
2016
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,682 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,695 Patients Enrolled for Multiple Myeloma
Meera Mohan, MDPrincipal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I haven't needed antibiotics for an infection in the last 2 weeks.I am not planning to receive any cancer treatment other than what this study offers from Day +30 post-transplant, except for local radiation or steroids for non-cancer conditions.My bone marrow test shows cancer cells after a stem cell transplant.I am not receiving treatment for any cancer other than multiple myeloma or secondary amyloidosis.Your absolute neutrophil count is at least 1,000 per cubic millimeter.You are allergic to certain ingredients in the study treatment and cannot take medication to prevent an allergic reaction.I have been diagnosed with symptomatic multiple myeloma, and I may have amyloidosis but won't receive treatment for it during the study.I do not have severe heart issues or uncontrolled arrhythmias.Your levels of ALT and AST should be no more than three times the upper limit of normal.I am registered and agree to follow the Revlimid REMS program requirements.My organs are functioning well.I don't have any serious health or mental conditions that could stop me from completing the treatment.I have not had major surgery in the last 14 days.I have a bone marrow sample from when I was diagnosed that can be used for genetic testing.You have an active hepatitis A, B, or C infection.I am able to get out of my bed or chair and move around.I had a stem cell transplant within a year of being diagnosed with myeloma.Your total bilirubin level is not more than 1.5 times the upper limit of normal.My multiple myeloma has worsened before joining this study.My platelet count is at least 75,000 without recent transfusions.I have had an organ transplant and am on immunosuppressive drugs.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: Isatuximab in combination with lenalidomide and dexamethasone.
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.
Has the FDA granted authorization for Isatuximab to be used in conjunction with lenalidomide and dexamethasone?
"The combination of Isatuximab, lenalidomide and dexamethasone received a score of 2 on our safety scale given the lack of data indicating its efficacy in Phase 2 trials."
Answered by AI
How many individuals have volunteered for this medical research?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently enrolling participants since it was published on June 26th 2023 and updated two days later. The study needs a total of 31 patients from one location."
Answered by AI
Are there any vacancies yet for participants in this medical research project?
"Affirmative. According to clinicaltrials.gov, this investigation is open for recruitment as of June 26th 2023 and was last edited on the 28th of that same month. The team seeks 31 volunteers from a single research centre."
Answered by AI
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