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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

Must not have

Participants less than 18 years old

Participants previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.

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

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I was treated with carfilzomib but didn't improve, or I finished my last therapy less than 14 days ago.

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I have had serious heart issues or a stroke in the last 6 months.

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I agree to use effective birth control during the study.

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I do not have active hepatitis or HIV/AIDS requiring treatment.

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My physical activity is very limited due to my health condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

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.

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