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Clinical trial to compare isatuximab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with asymptomatic high-risk multiple myeloma

PRELIMINARY SAFETY PHASE(S): THE OBJECTIVE OF THIS PART IS TO CONFIRM THE RECOMMENDED DOSE OF ISATUXIMAB (SAR650984) IN COMBINATION WITH LENALIDOMIDE (REVLIMID®) AND DEXAMETHASONE (ILD). PHASE 3 WITH RANDOMIZATION: THE OBJECTIVE OF THE STUDY IS TO EVALUATE THE EFFICACY AND POTENTIAL RISKS OF ISATUXIMAB (SAR650984) IN COMBINATION WITH LENALIDOMIDE (REVLIMID®) AND DEXAMETHASONE IN THE EXPERIMENTAL TREATMENT GROUP (ILD) COMPARED TO LENALIDOMIDE IN COMBINATION WITH DEXAMETHASONE IN THE TREATMENT GROUP REFERRED TO AS THE CONTROL GROUP (LD), IN THE TREATMENT OF THEIR DISEASE.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER CLINICAL TRIAL TO COMPARE ISATUXIMAB (SAR650984) IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE TO LENALIDOMIDE AND DEXAMETHASONE IN PATIENTS WITH ASYMPTOMATIC, HIGH-RISK MULTIPLE MYELOMA. IMMUNOTHERAPY
  • Code EudraCT: 2019-003139-47
  • Protocol number: EFC15992
  • Promoter: Sanofi-Aventis S.A.
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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