Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma

Summary

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.

Timeline

Start

2019-02-07

Primary completion

2022-09-15

Completion

2024-04-28

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped: “Early termination (regarding the follow-up of the patients). The required sample size was reached, and the primary endpoint was met.”

paper The primary end-point was ≥ very good partial response (VGPR) rate. PMID 42097596 ↗

paper VGPR or better was 32%. PMID 42097596 ↗

Publications

• Results Bobin A, Macro M, Touzeau C, Mariette C, Manier S, Brechignac S, Vincent L, Hebraud B, Decaux O, Schulman S, Lenoir C, Godmer P, Parienti JJ, Paul LPS, Briant A, Leleu X. A dexamethasone-free daratumumab-ixazomib regimen in frail elderly patients with relapsed or refractory multiple myeloma: Results of the IFM 2018-02 phase II study. Br J Haematol. 2026 Jul;209(1):127-135. doi: 10.1111/bjh.70512. Epub 2026 May 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daratumumab	Monoclonal antibody	16 mg/kg	—
Subject	Ixazomib	Unknown	4 mg	—

Indications