← Back to Search

Proteasome Inhibitor

Isatuximab + Carfilzomib + Dexamethasone for Multiple Myeloma (IKEMA 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

Participants with MM previously treated with prior 1 to 3 lines and with measurable serum M-protein (>= 0.5 gram/deciliter) and/or urine M-protein (>= 200 milligram/24 hours).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until the primary analysis data cut-off date of 7 feb 2020 (the median duration of follow-up was 20.73 months)

Awards & highlights

IKEMA Trial Summary

This trial is testing a new combination of drugs to see if it can help people with multiple myeloma who have not responded to other treatments.

Who is the study for?

This trial is for adults with multiple myeloma who've had 1-3 prior treatments. They must have measurable levels of M-protein in their blood or urine, and can't join if they're under 18, pregnant, not using birth control, previously treated with carfilzomib without response, or have certain heart conditions or severe infections.Check my eligibility

What is being tested?

The study tests the effectiveness of adding isatuximab to a combination of carfilzomib and dexamethasone versus just carfilzomib and dexamethasone in patients who have undergone previous therapies for multiple myeloma.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, increased risk of infections due to lowered immunity, potential heart issues like irregular heartbeat or heart failure, as well as general symptoms such as fatigue and nausea.

IKEMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have MM, treated 1-3 times before, with measurable M-protein in my blood or urine.

IKEMA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until the primary analysis data cut-off date of 7 feb 2020 (the median duration of follow-up was 20.73 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until the primary analysis data cut-off date of 7 feb 2020 (the median duration of follow-up was 20.73 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until the primary analysis data cut-off date of 7 feb 2020 (the median duration of follow-up was 20.73 months) for reporting.

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) As Determined by Independent Response Committee (IRC): Primary Analysis

Progression Free Survival as Determined by Independent Response Committee [Event Censored if Occurred >8 Weeks From Last Disease Assessment]: Final Analysis

Progression Free Survival as Determined by Independent Response Committee: Final Analysis

+1 more

Secondary outcome measures

Duration of Response (DOR): Primary Analysis

HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Body Image Score at Specified Timepoints: Primary Analysis

HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score at Specified Timepoints: Primary Analysis

+32 more

IKEMA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Isatuximab + Carfilzomib + Dexamethasone (IKd)Experimental Treatment3 Interventions

Isatuximab (intravenous) on day 1, 8, 15 and 22 of 1st cycle, then on day 1 and 15 of subsequent cycles in combination with carfilzomib (intravenous) on day 1, 2, 8, 9, 15 and 16 + dexamethasone (intravenous or by mouth [po]) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.

Group II: Carfilzomib + Dexamethasone (Kd)Active Control2 Interventions

Carfilzomib (intravenous) on day 1, 2, 8, 9, 15, 16 + dexamethasone (intravenous or po) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

isatuximab SAR650984

2013

Completed Phase 1

~150

carfilzomib

2010

Completed Phase 2

~710

dexamethasone

1995

Completed Phase 3

~9860

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,163 Previous Clinical Trials

3,512,178 Total Patients Enrolled

47 Trials studying Multiple Myeloma

9,899 Patients Enrolled for Multiple Myeloma

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,018,997 Total Patients Enrolled

22 Trials studying Multiple Myeloma

3,901 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03275285 — Phase 3

Multiple Myeloma Research Study Groups: Isatuximab + Carfilzomib + Dexamethasone (IKd), Carfilzomib + Dexamethasone (Kd)

Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT03275285 — Phase 3

Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03275285 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with carfilzomib?

"Just as with other Phase 3 trials, there is some data supporting efficacy and multiple rounds of data supporting safety, thus we have given carfilzomib a safety score of 3."

Answered by AI

Do we still have time to sign up for this experiment?

"This particular clinical trial, which was created on October 25th 2017 and last updated on May 10th 2022, is not actively recruiting patients. However, there are over 1400 other medical trials that are currently looking for volunteers."

Answered by AI

What are some benefits that patients have seen from taking carfilzomib?

"Carfilzomib is most commonly used to treat ophthalmia, but it can also be used to treat sympathetic conditions, branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

Are there any other reports of carfilzomib being used as a treatment?

"The first study investigating carfilzomib was completed in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. To date, there have been 1129 completed clinical trials and 604 active studies. A large number of these studies are being conducted in Surrey, South carolina."

Answered by AI

How many individuals will be participating in this experiment?

"Unfortunately, this particular trial is no longer recruiting patients. The trial was last updated on May 10th, 2022 and was originally posted on October 25th, 2017. However, there are currently 838 trials actively recruiting patients with multiple myeloma and 604 trials for carfilzomib that are open for enrollment."

Answered by AI