Oslo University Hospital is starting a new clinical trial of REST - Replacing Steroids in the Transplant Ineligble.
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.
Approximately 53 participants will be screened to achieve 50 enrolled (sample size) to study intervention. All participants will receive isatuximab in combination with bortezomib, lenalidomide and dexamethasone for 2 cycles, followed by isatuximab in combination with bortezomib and lenalidomide for 6 cycles, followed by isatuximab in combination with lenalidomide for 10 cycles, followed by continuous lenalidomide until disease progression. The cycle duration is 28 days.Bone marrow MRD Euroflow NGF will be assessed once in participants achieving CR/sCR during the first 18 cycles of treatment, and in all participants (except for those who already are defined as MRD negative) achieving VGPR or better after finishing the first 18 cycles of treatment to assess. Those who are in VGPR and are MRD negative after 18 cycles of treatment will be response evaluated monthly for up to 4 months and if they become >CR during this period they are defined as MRD negative. The cut-off for MRD negativity is 100 plasma cells per 100 million nucleated cells (10-5).
The clinical trial started in June 2021 and will continue throughout October 2026.
MRD negativity will be primary outcome measure. The proportion of patients who achieve MRD negativity measured by NGF Euroflow during and/or after 18 cycles of study treatment.
The contacts and locations are the Oslo University Hospital, Oslo, Norway; Helse Stavanger HF, Stavanger, Norway; St. Olav University Hospital, Trondheim, Norway. For more details: https://ichgcp.net/clinical-trials-registry/NCT04939844.