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Corticosteroid
Isatuximab + Pomalidomide + Dexamethasone for Multiple Myeloma (ICARIA-MM Trial)
Phase 3
Waitlist Available
Research Sponsored by Sanofi
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 pre-infusion on c1d1, c1d8, c1d15, c1d22, c2d1, c2d15, c3d1, c3d15, c4d1, c4d15, c5d1, c6d1, c7d1, c8d1, c9d1, c10d1, c11d1, c12d1, c13d1, c14d1, c15d1, c16d1, c17d1, c18d1, c19d1, c20d1; end of treatment (eot [30 days after last drug administration])
Awards & highlights
ICARIA-MM Trial Summary
This trial is testing a combination of drugs to see if it can help people with multiple myeloma that has gotten worse despite other treatments.
Eligible Conditions
- Multiple Myeloma
ICARIA-MM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization up to 30 days after last dose of study drug (maximum duration up to 241.6 weeks for pd arm and 245.6 weeks for ipd arm)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 30 days after last dose of study drug (maximum duration up to 241.6 weeks for pd arm and 245.6 weeks for ipd arm)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) Score
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment Domain Score
+20 moreICARIA-MM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IPd (isatuximab + pomalidomide + dexamethasone)Experimental Treatment3 Interventions
Participants received isatuximab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants >= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).
Group II: Pd (pomalidomide + dexamethasone)Active Control2 Interventions
Participants received pomalidomide 4 milligrams (mg) Per os (PO) on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants greater than or equal to (>=) 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
Dexamethasone
2007
Completed Phase 4
~2590
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,173 Total Patients Enrolled
47 Trials studying Multiple Myeloma
9,894 Patients Enrolled for Multiple Myeloma
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,992 Total Patients Enrolled
22 Trials studying Multiple Myeloma
3,896 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are legally considered an adult in your country, which is typically 18 years or older.You have been diagnosed with multiple myeloma and have evidence of the disease in your blood or urine tests.You have never responded to any treatment for multiple myeloma.Only participants with measurable free light chain disease will be considered.Your blood platelet count is too low, and you haven't had a platelet transfusion within the last three days.Your absolute neutrophil count is less than 1000 per microliter.You have taken pomalidomide before.You have taken any medication for myeloma within 14 days before the start of the study.You have a health status that is worse than moderate.Your AST or ALT levels are more than three times higher than the upper limit of normal.You had a bad reaction to thalidomide or lenalidomide that made you stop taking them within the first two cycles of treatment.You are allergic to dexamethasone, sucrose histidine, or polysorbate 80, and cannot take medications to prevent an allergic reaction before treatment.You have a serious heart problem, had a heart attack in the past year, or have unstable and uncontrolled chest pain.Your kidneys are not able to filter waste products well, as measured by a test called creatinine clearance.Your bilirubin levels are higher than twice the upper limit of normal.Your corrected serum calcium level is higher than 14 mg/dL (3.5 mmol/L).You have been diagnosed with multiple myeloma and have evidence of the disease in your blood or urine.You have already had at least two rounds of treatment for myeloma, including both lenalidomide and a proteasome inhibitor like bortezomib.You have not responded to the last treatment you received within the past two months.You have previously received and did not respond well to lenalidomide and certain types of proteasome inhibitors.You have not responded to or stopped responding to the last treatment within the past 60 days.You have already tried at least two different treatments for myeloma, including specific medications called lenalidomide and a proteasome inhibitor.You have already tried and did not respond to treatments with lenalidomide and certain other medications.
Research Study Groups:
This trial has the following groups:- Group 1: IPd (isatuximab + pomalidomide + dexamethasone)
- Group 2: Pd (pomalidomide + dexamethasone)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Is this clinical trial widely available to patients in Canada?
"If you are interested in enrolling in this study, know that there are ten sites presently recruiting. The locations are based in Plantation, Boston and Sherbrooke as well as 10 other locations. To minimize travel requirements, try and select the site closest to you."
Answered by AI
Are there any available spots left for volunteers in this research project?
"This study is not open for patient recruitment at the moment. According to the latest update on September 26th, 2022, this study was first posted on December 22nd, 2016. For patients looking for other studies, 838 studies for neoplasms and 610 studies for Isatuximab are open and actively enrolling patients."
Answered by AI
What is the primary disease that Isatuximab is used to target?
"Isatuximab is a medication used to treat ophthalmia, sympathetic. It has also been found to be helpful in managing branch retinal vein occlusion, macular edema, and communicable diseases."
Answered by AI
Can you give me more information on other research that has been done on Isatuximab?
"So far, 1137 studies on isatuximab have been completed with 610 more recruiting patients as of now. Most of these active trials are located in Plantation, Massachusetts. The first study on isatuximab was done in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba."
Answered by AI
How many people are the most that are allowed to enroll in this research study?
"Enrollment for this study is closed at the moment. The trial was first posted on December 22nd, 2016 and was last updated on September 26th, 2022. For those looking for similar studies, 838 trials for neoplasms, plasma cell and 610 trials for Isatuximab are actively enrolling patients."
Answered by AI
Has Isatuximab been cleared by the FDA?
"Because Isatuximab is being trialled in Phase 3, there is some data to support its efficacy and multiple rounds of data affirming its safety, so our team at Power gave it a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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