REST - Replacing Steroids in the Transplant Ineligble

Phase 2 Completed 51 enrolled Oslo University Hospital Helse Stavanger HF · collab Nordic Myeloma Study Group · collab St. Olavs Hospital · collab

NaSingle-groupOpen-labelTreatment

Summary

Newly diagnosed multiple myeloma patients ineligible for HD-ASCT will be included in the study. All participants will receive isatuximab in combination with bortezomib, lenalidomide and minimal dexamethasone until disease progression. The primary objective of this study is the MRD negativity rate during and/or after first 18 cycles of study treatment.

Timeline

Start: 2021-06-29
Primary completion: 2024-08-31
Completion: 2024-08-31

Publications

Askeland FB, Haukas E, Slordahl TS, Klostergaard A, Alexandersen T, Lysen A, Abdollahi P, Nielsen LK, Hermansen E, Schjesvold F. Isatuximab, bortezomib, lenalidomide, and limited dexamethasone in patients with transplant-ineligible multiple myeloma (REST): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Feb;12(2):e120-e127. doi: 10.1016/S2352-3026(24)00347-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.3 mg/m2	Subcutaneous
Subject	Dexamethasone	Small molecule	20 mg	Oral
Subject	Isatuximab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Lenalidomide	Other / unclassified	25 mg	Oral

REST - Replacing Steroids in the Transplant Ineligble

Summary

Timeline

Publications

Drugs

Indications