Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients (IKEMA)
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ClinicalTrials.gov Identifier: NCT03275285 |
Recruitment Status :
Active, not recruiting
First Posted : September 7, 2017
Last Update Posted : May 12, 2022
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Primary Objective:
To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.
Secondary Objectives:
- To evaluate the Overall Response Rate (ORR), rate of very good partial response (VGPR) or better and complete response (CR) rate in both arms using International Myeloma Working Group (IMWG) criteria.
- To evaluate rate of VGPR or better with minimal residual disease (MRD) negativity in both arms using IMWG criteria.
- To evaluate the Overall Survival (OS) in both arms.
- To evaluate safety in both arms.
- To evaluate duration of response (DOR) in both arms.
- To evaluate the Time To Progression (TTP) in both arms.
- To evaluate the Second Progression Free Survival (PFS2) in both arms.
- To evaluate the Time to first response
- To evaluate the Time to best response
- To determine the Pharmacokinetic profile of isatuximab in combination with carfilzomib.
- To evaluate the immunogenicity of isatuximab in isatuximab arm.
- To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status in both arms.
Condition or disease | Intervention/treatment | Phase |
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Plasma Cell Myeloma | Drug: isatuximab SAR650984 Drug: carfilzomib Drug: dexamethasone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 302 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines |
Actual Study Start Date : | October 25, 2017 |
Actual Primary Completion Date : | January 21, 2022 |
Estimated Study Completion Date : | February 7, 2023 |

Arm | Intervention/treatment |
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Experimental: Isatuximab + Carfilzomib + Dexamethasone (IKd)
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
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Drug: isatuximab SAR650984
Pharmaceutical form: solution for infusion Route of administration: intravenous Other Name: Sarclisa Drug: carfilzomib Pharmaceutical form: solution for infusion Route of administration: intravenous Other Name: Kyprolis Drug: dexamethasone Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous |
Active Comparator: Carfilzomib + Dexamethasone (Kd)
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
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Drug: carfilzomib
Pharmaceutical form: solution for infusion Route of administration: intravenous Other Name: Kyprolis Drug: dexamethasone Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous |
- Progression Free Survival (PFS) [ Time Frame: Up to approximately 60 months ]The length of time between treatment allocation and a patient lives with the disease but it does not get worse
- Overall Response Rate (ORR) [ Time Frame: Up to approximately 60 months ]The proportion of patients that have a response to their disease: stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR)
- Rate of VGPR or better [ Time Frame: Up to approximately 60 months ]The proportion of patients with sCR, CR and VGPR
- CR rate [ Time Frame: Up to approximately 60 months ]The proportion of patients with sCR and CR
- Rate of VGPR or better with MRD (Minimal Residual Disease) negativity [ Time Frame: Up to approximately 60 months ]The proportion of patients for whom MRD assessed by sequencing is negative at any time after first dose of study treatment
- Overall Survival (OS) [ Time Frame: Up to approximately 60 months ]The length of time from the treatment allocation for a disease that patients are still alive
- Time to Progression (TTP) [ Time Frame: Up to approximately 60 months ]How long the study treatment last before disease progression occurs
- Second Progression Free Survival (PFS2) [ Time Frame: Up to approximately 60 months ]The length of time between treatment allocation to the date of first documentation of PD after initiation of further anti-myeloma treatment or death from any cause, whichever happens first
- Duration of response (DOR) [ Time Frame: Up to approximately 60 months ]How long from the first response is observed until disease progression
- Number of patients with adverse events according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 grading scaling [ Time Frame: Up to 30 days after last study treatment administration ]To evaluate how many adverse events occur while taking study treatment
- Patient-reported outcome measured with Quality of Life questionnaire [ Time Frame: Screening to 90 days after last study treatment administration ]To evaluate change in daily activities from screening
- Pharmacokinetics of isatuximab [ Time Frame: Up to approximately 10 months ]To evaluate the plasma concentration of isatuximab
- Pharmacokinetics of carfilzomib [ Time Frame: Up to 1 month ]To evaluate the plasma concentration of carfilzomib in 12 patients
- Immunogenicity (ADA) [ Time Frame: Up to 13 months ]To evaluate presence of anti-drug antibodies against isatuximab
- Time to first response [ Time Frame: Up to approximately 60 months ]Length of time from treatment allocation to the date of first response (PR or better)
- Time to best response [ Time Frame: Up to approximately 60 months ]Length of time from treatment allocation to the date of first best overall response (PR or better)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patients with multiple myeloma previously treated with prior 1 to 3 lines and with measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours).
Exclusion criteria:
- Patients 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.
- Patients with serum free light chain (FLC) measurable disease only.
- Patients less than 18 years old, patients with Eastern Cooperative Oncology Group performance status more than 2.
- Patients with inadequate biological tests.
- Patients with myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.
- Patients with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
- Patients with known acquired immunodeficiency syndrome related illness (AIDS) or human immunodeficiency virus (HIV) requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
- Women of childbearing potential or male patient with women of childbearing potential who do not agree to use highly effective method of birth control.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275285

Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT03275285 |
Other Study ID Numbers: |
EFC15246 2017-001940-37 ( EudraCT Number ) U1111-1195-5957 ( Other Identifier: UTN ) |
First Posted: | September 7, 2017 Key Record Dates |
Last Update Posted: | May 12, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Anti-CD38 monoclonal antibody |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders |
Immune System Diseases Dexamethasone Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |