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NCT04458831: IONA-MM
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
trial testing isatuximab SAR650984 in Plasma Cell Myeloma in 583 participants. Participants enrolled and being followed up; not accepting new ones.
23 February 2026
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 583 |
| Start date | 13 August 2020 |
| Primary completion | 23 February 2026 |
| Estimated completion | 23 February 2026 |
| Sites | 129 locations across Hong Kong, Italy, Japan, Taiwan, Netherlands, Russia, Belgium, United States |
Drugs / interventions tested
- isatuximab SAR650984
- Pomalidomide — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
- Carfilzomib (carfilzomib) — full drug profile →
Conditions studied
- Plasma Cell Myeloma — all drugs for Plasma Cell Myeloma →
Sponsor
Sanofi — full company profile →
Who can join
18 and older, any sex, with Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event \[AE\] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Isatuximab: A Review of Its Use in Multiple Myeloma.
Frampton JE. · · 2021 · cited 28× · PMID 34351561 · DOI 10.1007/s11523-021-00827-0 -
Isatuximab in the Treatment of Multiple Myeloma: A Review and Comparison With Daratumumab.
Shen F, Shen W. · · 2022 · cited 27× · PMID 35903924 · DOI 10.1177/15330338221106563 -
Ikaros Proteins in Tumor: Current Perspectives and New Developments.
Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440
Verify or expand the search:
- PubMed search for NCT04458831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of isatuximab SAR650984
Trials testing the same drug.
- NCT03769181 — A Study of Isatuximab-based Therapy in Participants With Lymphoma · Phase 1, PHASE2 · terminated
- NCT03275285 — Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Rel · Phase 3 · completed
- NCT02513186 — Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + De · Phase 1 · completed
- NCT01749969 — SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients · Phase 1 · completed
Other recruiting trials for Plasma Cell Myeloma
Currently open trials in the same condition.
- NCT04876248 — Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Po · Phase 2 · active not recruiting
- NCT05561387 — Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Me · Phase 3 · recruiting
- NCT05892393 — Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma · Phase 1 · recruiting
- NCT05669989 — International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefi · Phase 2 · active not recruiting
- NCT05392946 — Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study · Phase 1, PHASE2 · active not recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04458831 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 27 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04458831.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing