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Proteasome Inhibitor
Isatuximab + VRd for Multiple Myeloma (IMROZ 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
Multiple myeloma (IMWG criteria)
Newly diagnosed multiple myeloma not eligible for transplant due to age (≥ 65 years) or patients < 65 years with comorbidities impacting possibility of transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after end of treatment (eot) visit
Awards & highlights
IMROZ Trial Summary
This trial is testing a new cancer drug combination to see if it can prolong progression-free survival in patients with newly diagnosed multiple myeloma who are not eligible for transplant.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who can't have a transplant because they're over 65 or under 65 with other health issues. They must have measurable disease signs and agree to use contraception if necessary. It's not for those under 18, previously treated for myeloma, or with certain health conditions that could interfere.Check my eligibility
What is being tested?
The study tests whether adding Isatuximab (SAR650984) to the combo of Bortezomib, Lenalidomide, and Dexamethasone improves survival without cancer progression in new multiple myeloma patients ineligible for transplant compared to just the three-drug combo.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, increased risk of infections due to low blood cell counts, nerve damage causing pain or numbness (neuropathy), blood clots, diarrhea, fatigue, and potential allergic reactions.
IMROZ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma.
Select...
I am over 65 or have health issues that prevent a bone marrow transplant for my newly diagnosed multiple myeloma.
Select...
I am over 65 or have health issues that prevent a bone marrow transplant for my newly diagnosed multiple myeloma.
IMROZ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after end of treatment (eot) visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after end of treatment (eot) visit
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
Adverse Events
Assessment of PK parameter: Ctrough
Complete response rate (CR)
+15 moreSide effects data
From 2008 Phase 2 trial • 20 Patients • NCT00006184100%
Injection site reaction
40%
Fatigue (asthenia, lethargy, malaise)
30%
Pruritus
30%
Platelets
30%
Chest pain (non-cardiac and non-pleuritic)
30%
Bone pain
30%
Headache
30%
Myalgia (muscle ache)
30%
SGPT (ALT)
30%
Abdominal pain or cramping
20%
Alkaline phosphatase
20%
Hypokalemia
20%
Dizziness/lightheadedness
20%
Arthralgia (joint pain)
20%
Hypomagnesemia
20%
Pain - Other
20%
Rash/desquamation
20%
Rigors/chills
20%
SGOT (AST)
10%
Hypoalbuminemia
10%
Hypocalcemia
10%
Hot flashes/flushes
10%
Hypophosphatemia
10%
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
10%
Lymphopenia
10%
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis
10%
Dry skin
10%
Constipation
10%
Hypotension
10%
Joint, muscle, or bone (osseous)- Other (Calf cramping)
10%
Hypercalcemia
10%
Skin-Other (Drug reaction face, hands, neck)
10%
Hematologic-Other (Splenomegaly in donor-resolved)
10%
Dyspnea (shortness of breath)
10%
Rash/desquamation for BMT
10%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor - Vaccination Generation Group
Recipient - Chemotherapy Group
IMROZ Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Isatuximab/Lenalidomide/Dexamethasone = IRd crossover armExperimental Treatment3 Interventions
4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Group II: Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd armExperimental Treatment4 Interventions
Induction treatment with 4x6-week cycles with intravenous (IV) isatuximab + subcutaneous (SC) bortezomib + oral lenalidomide + IV or oral dexamethasone
Continuous treatment with 4-week cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone
Group III: Bortezomib/Lenalidomide/Dexamethasone = VRd armActive Control3 Interventions
Induction treatment with 4x6-week cycles with SC bortezomib + oral lenalidomide + IV or oral dexamethasone
Continuous treatment with 4-week cycles with oral lenalidomide + IV or oral dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab SAR650984
2015
Completed Phase 2
~580
Bortezomib
2005
Completed Phase 2
~1140
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,005 Total Patients Enrolled
47 Trials studying Multiple Myeloma
9,726 Patients Enrolled for Multiple Myeloma
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,824 Total Patients Enrolled
22 Trials studying Multiple Myeloma
3,728 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with multiple myeloma.I am over 65 or have health issues that prevent a bone marrow transplant for my newly diagnosed multiple myeloma.I have been diagnosed with multiple myeloma.I am over 65 or have health issues that prevent a bone marrow transplant for my newly diagnosed multiple myeloma.You have read and understood the information about the study, and have agreed to participate by signing a document.My organ functions are not within the required range.I am a male and agree to follow contraceptive advice during the study.I am under 18 years old.I have received treatment for multiple myeloma before.You are very sensitive or allergic to the study medications.My daily activity is significantly limited due to my health.There are signs of a health problem that can be measured.I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception.There is evidence that the disease can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: Bortezomib/Lenalidomide/Dexamethasone = VRd arm
- Group 2: Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd arm
- Group 3: Isatuximab/Lenalidomide/Dexamethasone = IRd crossover arm
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
If a person is below the age of 55, would they still be eligible for this kind of research?
"The age limit for this clinical trial is 80 years old, provided that the candidate is also above 18 years old."
Answered by AI
Could you please tell me how many different hospitals are a part of this research?
"Presently, this trial is recruiting from 11 sites. The locations are situated in Kansas City, Nashville and Houston as well as other locations. If you are hoping to participate, it would be advantageous to select the clinic nearest to your location to avoid travel difficulties."
Answered by AI
How may I become a part of this clinical trial?
"This study is looking for 475 individuals that have multiple myeloma and are aged between 18-80. The most important criterion that participants must meet is having multiple myeloma (as specified by the IMWG). Other notable requirements include being newly diagnosed, not being eligible for transplant, having evidence of measurable disease, and providing written informed consent."
Answered by AI
Could you please list other cases where Diphenhydramine has been used in medical trials?
"Diphenhydramine was first investigated in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Today, a total of 2392 studies have been completed. 880 more are currently underway, with a large portion of these taking place in Kansas City, Missouri."
Answered by AI
What is the maximum recruitment goal for this research project?
"This clinical trial is no longer enrolling patients. The study was posted on December 7th, 2017 and was last edited on November 3rd, 2022. If you are looking for other studies, 837 trials for multiple myeloma and 880 trials for Diphenhydramine or equivalent are currently enrolling patients."
Answered by AI
For what reasons are people typically prescribed Diphenhydramine?
"The active ingredient diphenhydramine is most often used to treat macular edema. However, it has also been shown to ameliorate ulcerative colitis, eye conditions, and varicella-zoster virus acute retinal necrosis."
Answered by AI
What over-the-counter medications are available to treat the same symptoms?
"Diphenhydramine has been studied extensively and is considered safe. It received a score of 3 on our safety scale."
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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