Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

ConditionSmoldering Multiple Myeloma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorStichting European Myeloma Network

About this trial

This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.

Eligibility criteria

Qualifiers

>18 years of age

BMPCs ≥10% and <60%

Presence of at least 2 high risk factors, including

Serum M protein ≥2 g/dL,

Disqualifiers

Previous therapy with any systemic therapy for multiple myeloma.

Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL

Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m² (Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL

Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted