• Active, not recruiting

NCT03275285: Phase 3 - Isatuximab, Carf & Dex VS Carf And Dex In Relapse Multiple Myeloma (IKEMA)

Updated: Sep 26

IKEMA

Isa-Kd Vs Kd

IKEMA isatuximab myeloma trial

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients (IKEMA)


The duration of the study for the patients will include a period for screening of up to 3 weeks. Patients will continue study treatment until disease progression, unacceptable adverse reaction, patients' wish or other reason of discontinuation. During follow-up, patients who discontinue the study treatment due to progression of the disease will be followed every 3 months (12 weeks) for further anti-myeloma therapies, progression free survival to the second progression and survival, until death or the cut-off date, whichever comes first. Patients who discontinue the study treatment prior to documentation of disease progression will be followed-up every 4 weeks until confirmation of disease progression, and then every 3 months (12 weeks) for further anti-myeloma therapies, progression free survival to the second progression and survival, until death or the cut-off date, whichever comes first. After progression free survival analysis, patients will be followed yearly for 3 years for survival.


Sponsor:

Sanofi


Multiple Locations

International study

 

ClinicalTrials.gov Identifier: NCT03275285

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

First Posted : September 7, 2017

Click here for details on ClinicalTrials.gov

 

Isatuximab : National Cancer Institute

Isatuximab : MedlinePlus Drug Information

 

414 Depth of Response and Response Kinetics of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma: Ikema Interim Analysis

Program: Oral and Poster Abstracts

Type: Oral

Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Relapsed/Refractory Multiple Myeloma

Hematology Disease Topics & Pathways:

Biological, antibodies, Adult, Therapies, immunotherapy, Study Population, Clinically relevant

Sunday, December 6, 2020: 12:30 PM


Click here for details

 

Future Oncol. 2020 Jan;16

Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design.


Click here for details

 

ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE VERSUS CARFILZOMIB AND DEXAMETHASONE IN ELDERLY PATIENTS WITH RELAPSED MULTIPLE MYELOMA: IKEMA SUBGROUP ANALYSIS

EHA Library. 06/09/21


Click here for details

 

Press Release: Sarclisa® (isatuximab) combination provides unprecedented median progression free survival in patients with relapsed multiple myeloma receiving a proteasome inhibitor therapy


PARIS, May 15, 2022. Latest results from the Phase 3 IKEMA clinical trial evaluating Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone (Kd) demonstrated a median progression free survival (mPFS) of 35.7 months (Hazard Ratio HR 0.58; 95% Confidence Interval CI: 25.8 to 44.0; n=179), compared to 19.2 months in patients treated with Kd alone (95% CI: 15.8 to 25.1; n=123), as evaluated by an Independent Review Committee. These results, presented at the Controversies in Multiple Myeloma World Congress, represent the longest mPFS among studies investigating a proteasome inhibitor backbone in the second-line setting for the treatment of relapsed multiple myeloma (MM). These data will also be presented at the European Society for Medical Oncology on May 19.


Click here for details

 

Lancet. 2021 Jun 19

Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial.


Click here for details

 

COMY 22 - Session 15: Abstract communications

Updated progression-free survival (PFS) and depth of response in IKEMA, a randomized Phase 3 trial of isatuximab, carfilzomib and dexamethasone (Isa-Kd) vs Kd in relapsed multiple myeloma (MM)

Click here for details

 

OAB-046 Depth of Response of Isatuximab plus Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma: IKEMA Updated Analysis -Roman Hájek


#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California

IMS 2022 Abstract EBook

https://www.myelomasociety.org/


#IMS2022 - 19th International Myeloma Society Annual Meeting; Aug 25-27, LA California (themyelomaclinicaltrials.com)

 

Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics: IKEMA subgroup analysis

Eur J Haematol; 2022

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