Multiple Myeloma
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGSelinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy
Patients were treated by Selinexor (40mg po qw d1-28) combined with Ixazomib (4mg po on days 1, 8, and 15 in 28-day cycles) and Lenalidomide(10mg po qd d1-21) as Maintenance Therapy.
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 years | PFS was defined as the time from study entry until disease progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EFS | 2 years | EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first. |
| OS | 2 years | OS was defined as the time from treatment initiation to death by any cause. |
Contacts
Primary ContactLiren Qian, PhD
Backup ContactLiren Qian
Outcome results
None listed