- Active, not recruiting
NCT03606577: Phase 2-IFM 2018 - 04 - Quadruplet Induction & Consolidation + Tandem ASCT Hi Risk NDMM
Updated: Oct 24, 2022
IFM 2018-04
NCT03606577: Phase 2: An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients (IFM 2018-04)
Dara-KRd
An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients (IFM 2018-04)
According to international guidelines, upfront therapy for transplant eligible myeloma patients should include triplet induction containing proteasome inhibitor and immunomodulatory agent, autologous stem cell transplant, PI+Imid based triplet consolidation and lenalidomide maintenance. Despite this approach, virtually all MM patients experience disease relapse, especially those with High Risk disease defined by adverse cytogenetic abnormalities (i.e. del(17p), or t(14;16) or t(4;14)) detected by FISH and/or SNP arrays. Indeed, HR myeloma is associated with poorer progression free survival and overall survival and frontline therapy should therefore be improved for this subset of HR patients. The primary objective of this prospective multicenter, open label, interventional phase 2 trial is to evaluate the feasibility of an intensive program including quadruplet induction and consolidation, tandem autologous stem cell transplantation and maintenance in newly diagnosed multiple myeloma patients presenting with HR cytogenetic. Quadruplet induction and consolidation include carfilzomib, lenalidomide, dexamethasone and daratumumab. Maintenance will include lenalidomide and daratumumab. Secondary objectives will include efficacy parameters (i.e. response rate, minimal residual disease, safety, progression free survival, overall survival).
Sponsor
Nantes University Hospital
Location
France
ClinicalTrials.gov Identifier: NCT03606577
Intervention Model Description: One group of subjects who must have documented Multiple Myeloma High Risk satisfying the CRAB and measurable disease.
First Posted : July 31, 2018
Click here to see details on ClinicalTrials.gov
IFM 2018-04
Drug: Carfilzomib
Drug: Daratumumab
Drug: Lenalidomide
Drug: Dexamethasone
EHA 2022 Oral Presentations
EHA 2022 - HYBRID - JUNE 9-17 - VIENNA
DARATUMUMAB CARFILZOMIB LENALIDOMIDE AND DEXAMETHASONE AS INDUCTION THERAPY IN HIGH-RISK TRANSPLANT ELIGIBLE NEWLY DIAGNOSED MYELOMA PATIENTS: RESULTS OF THE PHASE 2 STUDY IFM 2018-04
Meeting: 2022 ASCO Annual Meeting - Session Type: Oral Abstract Session - Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia - Track: Hematologic Malignancies - Sub Track: Hematologic Malignancies - Clinical Trial Registration Number: NCT03606577
Abstract#: 8002 - Daratumumab carfilzomib lenalidomide and dexamethasone as induction therapy in high-risk, transplant-eligible patients with newly diagnosed myeloma: Results of the phase 2 study IFM 2018-04.
ABSTRACTS & PRESENTATIONS
2022 ASCO ANNUAL MEETING - June 3-7, 2022 - McCormick Place, Chicago, IL - Hybrid Meeting
2022 ASCO Annual Meeting - Oral Abstract Session
June 29, 2022
International Myeloma Foundation
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OAB-041 Daratumumab Carfilzomib Lenalidomide and Dexamethasone as induction therapy in high-risk transplant eligible newly diagnosed myeloma patients: results of the phase 2 study IFM 2018-04 -Cyrille Touzeau
#IMS2022 - 19th International Myeloma Society Annual Meeting; August 25-27, 2022 - LA, California
Location
France