NCT03275285: Phase 3 - Isatuximab, Carf & Dex VS Carf And Dex In Relapse Multiple Myeloma (IKEMA)
Updated: Sep 26, 2022
Isa-Kd Vs Kd
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.
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
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
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
Future Oncol. 2020 Jan;16
Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design.
ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE VERSUS CARFILZOMIB AND DEXAMETHASONE IN ELDERLY PATIENTS WITH RELAPSED MULTIPLE MYELOMA: IKEMA SUBGROUP ANALYSIS
EHA Library. 06/09/21
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.
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Lancet. 2021 Jun 19
Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial.
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)
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
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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