NCT05900882

SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease

An Open Label, Single Arm, Multi-Center Exploratory Study to Evaluate the Efficacy and Safety of SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease.

Detailed description

Study Design: This protocol corresponds to a multicenter, open-label, single arm, exploratory study designed to determine the safety of the combination of selinexor combined with VRd in NDMM patients presenting with EMD. The patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation or no ASCT and followed by consolidation and maintenance treatment. All patients will receive 4 courses of SVRd induction therapy, each cycle of treatment will compromise 4 weeks of Selinexor 60mg QW treatment. Transplantation could be performed after 2 courses of VRd consolidation therapy. If not receive transplantation will give 4 cycles of SVRd consolidation therapy. Maintenance treatment will continued for a maximum of 2 years. Study design allows 35 patients. Induction treatment will consist of Selinexor 60 mg/day orally on d1,8,15,22, Bortezomib 1.3mg/m2 intravenously on d1,8,15,22, Lenalidomide 25 mg/d ( the dose will be adjusted according to creatinine clearance), orally on days 1 to14, Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Selinexor	Selinexor 60 mg/day, orally on d1,8,15,22
DRUG	Bortezomib	Bortezomib 1.3mg/m2 intravenously on d1,8,15,22
DRUG	Lenalidomide	Lenalidomide 25 mg/d (the dose will be adjusted according to creatinine clearance)
DRUG	Dexamethasone	Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

Timeline

• Start date: 2022-07-15
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2023-06-13
• Last updated: 2025-08-17

Locations

6 sites across 1 country: China