SIL as Maintenance Therapy in Multiple Myeloma

Navy General Hospital, Beijing

Status and phase

Not yet enrolling

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06744894

SIL2024

Details and patient eligibility

About

The goal of this phase 2 trial is to test the safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma.

Full description

The investigators will evaluate safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma post complete remission. Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Enrollment

50 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pathologically confirmed Multiple Myeloma according World Health Organization (WHO) classification;
Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria.

Exclusion criteria

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
Pregnant or lactating women