Ixazomib combined with low-dose lenalidomide(10mg) vs Ixazomib alone as maintenance regimen in patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen.
This study was designed to investigate whether the oral proteasome inhibitor ixazomib combined with low-dose lenalidomide(10mg) as a maintenance regimen could improve the outcome and prognosis of patients with high-risk multiple myeloma after induction and consolidation of VRD-based regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Whether Ixazomib combined with low-dose lenalidomide improves the outcome and prognosis of patients with high-risk multiple myeloma as a maintenance treatment option compared to ixazolomib alone
Ixazomib alone
Yang Xu
Hangzhou, Zhejiang, China
RECRUITINGProgression-Free Survival (PFS)
PFS is defined as the time from the date of first dose of study drug to the first occurrence of PD as evaluated by the investigator or death from any cause, whichever occurs first. PD is defined as \>=25% increase from lowest value in serum M component or urine M-component; difference between involved and uninvolved free light chain (FLC) levels (absolute increase \>10 mg/dL); bone marrow plasma cell percent \>/=10%; new bone lesions or soft tissue plasmacytomas development or definite increase in existing bone lesions/soft tissue plasmacytomas size; hypercalcaemia development.
Time frame: through study completion, a average of 1 year
Very Good Partial Response (VGPR) + Complete Response (CR) Rate
Using IMWG criteria
Time frame: through study completion, a average of 1 year
Overall Survival (OS)
OS is measured as the time from the date of first dose of study drug to the date of death.
Time frame: through study completion, a average of 1 year
Percentage of Participants with Adverse Events (AEs)
Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after the last dose of study drug.
Time frame: through study completion, a average of 1 year
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