NCT03757221: Phase 2 - IFM 2018-02 - Ixazomib -Daratumumab Without Dex in Elderly RRMM (IDARA)
Updated: Jun 15, 2022
NCT03757221: Phase 2 - Ixazomib -Daratumumab Without Dex (IDara) in Elderly RRMM (IDARA)
Phase 2 Study
Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma (IDARA)
Multiple myeloma is an incurable hematological malignancy that affects older patients. Currently, despite recent progress, the disease relapses more or less quickly after initial treatment and requires the resumption of treatment with new drugs associated with cortisone, whose side effects are important. The investigators propose to conduct a phase 2 testing the combination ixazomib - daratumumab without dexamethasone.
ClinicalTrials.gov Identifier: NCT03757221
Official Title:A Multicentre Open-label Phase II Study of Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma
First Posted : November 28, 2018
Click here for details on ClinicalTrials.gov
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: NCT03757221
Abstract#: 8000 - Ixazomib and daratumumab without dexamethasone (I-Dara) in elderly frail RRMM patients: A multicenter phase 2 study (IFM 2018-02) of the Intergroupe Francophone du Myélome (IFM).
ABSTRACTS & PRESENTATIONS
2022 ASCO ANNUAL MEETING - June 3-7, 2022 - McCormick Place, Chicago, IL - Hybrid Meeting
2022 ASCO Annual Meeting - Oral Abstract Session
83 Ixazomib and Daratumumab without Dexamethasone (I-Dara) in Elderly Frail RRMM Patients. a Multicenter Phase 2 Study (IFM 2018-02) of the Intergroupe Francophone Du Myélome (IFM)
Program: Oral and Poster Abstracts
Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Phase 2 and 3 Trials in Myeloma
Hematology Disease Topics & Pathways:
Clinical Trials, Non-Biological, Clinical Research, Plasma Cell Disorders, Chemotherapy, Elderly, Diseases, Therapies, Lymphoid Malignancies, Study Population
Saturday, December 11, 2021: 10:15 AM
Conclusions: These preliminary results show a favorable safety profile of ixazomib and daratumumab combination, without dexamethasone, in this specific population of very elderly frail patients with RRMM and high risk cytogenetic for almost one third of them. Efficacy results will be analyzed when the 50 patients will be enrolled in the study and evaluable for the primary endpoint.