IRAKLIA Trial: Isatuximab On-Body vs IV in RRMM
- Milan—A phase 3 trial, IRAKLIA, is underway to assess a new method of delivering isatuximab, a CD38 monoclonal antibody, for patients with relapsed or refractory multiple myeloma.
- Isatuximab, currently administered intravenously, has proven effective in treating myeloma.
- The goal is to determine if the subcutaneous isatuximab,a key primary_keyword,with OBI is non-inferior to the intravenous version in terms of efficacy,while offering improved convenience,safety,and quality of life.
IRAKLIA trial results could redefine multiple myeloma treatment. This phase 3 study investigates subcutaneous isatuximab, a key primarykeyword delivered via an on-body injector (OBI), comparing it to the traditional intravenous method in patients with relapsed or refractory multiple myeloma. Researchers aim to prove non-inferiority in efficacy while enhancing convenience and quality of life for patients. The study assesses overall response rate and minimal serum concentration, along with safety and patient experience, using the subcutaneous formulation, a secondarykeyword1, as a potential new approach for myeloma patients, a secondarykeyword_2. stay informed with News Directory 3 for the latest updates on this transformative trial sponsored by Sanofi. Data from IRAKLIA will shape future standards of care. Discover what’s next …
IRAKLIA Trial Tests New Isatuximab Delivery for Multiple Myeloma
Updated June 15, 2025
Milan—A phase 3 trial, IRAKLIA, is underway to assess a new method of delivering isatuximab, a CD38 monoclonal antibody, for patients with relapsed or refractory multiple myeloma. Dr. Xavier leleu, head of Haematology at Hôpital La Mileterie in Poitiers, France, discussed the trial’s objectives at the European Hematology Association Congress.
Isatuximab, currently administered intravenously, has proven effective in treating myeloma. However, intravenous infusions can be inconvenient for patients requiring long-term treatment. The IRAKLIA trial explores a subcutaneous formulation of isatuximab delivered via an on-body injector (OBI) system.
The goal is to determine if the subcutaneous isatuximab,a key primary_keyword,with OBI is non-inferior to the intravenous version in terms of efficacy,while offering improved convenience,safety,and quality of life. The study, sponsored by Sanofi, randomizes patients to receive either intravenous isatuximab or subcutaneous isatuximab with OBI, both in combination with pomalidomide and dexamethasone.
The trial’s primary endpoints include overall response rate and minimal serum concentration of the drug. Secondary endpoints include very good partial response or better, safety profile, quality of life, and early minimal serum concentration. Researchers hope the subcutaneous formulation, a secondary_keyword_1, will provide a more convenient and effective treatment option for myeloma patients, a secondary_keyword_2.
Leleu emphasized the potential benefits of the OBI system.”That’s exactly why we think isatuximab, with subcutaneous formulation, with the OBI, is such vital progress for the patients, for their families, and for the teams in the field of myeloma,” Leleu said.
What’s next
The results of the IRAKLIA trial will determine weather the subcutaneous isatuximab formulation with OBI becomes a new standard of care for patients with relapsed or refractory multiple myeloma. Approval and reimbursement decisions will depend on the trial’s findings.