The purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
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)
Changzhou Second People's Hospital
Changzhou, Jiangsu, China
Nanjing First People's Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Number of Participants With Overall Response Rate (ORR)
ORR: defined as the proportion of patients who will achieve PR or better, as per IMWG criteria.
Time frame: End of induction treatment (4 cycles, each cycle is 28 days)
Number of Participants With Complete Response Rate (CR)
CR: defined as the proportion of patients who will achieve CR, as per IMWG criteria.
Time frame: End of induction treatment (4 cycles, each cycle is 28 days)
Duration of Response (DOR)
DOR: defined as time, in months, from initial response (PR or better) until the date of a disease progression event
Time frame: 5 years
Progression-Free Survival (PFS)
PFS: was calculated from the time of informed consent to the date of recurrence or death, whichever occurred first. Patients were censored at the date of the last follow-up visit if they were alive without relapse.
Time frame: 5 years
Overall Survival (OS)
OS was calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up.
Time frame: 5 years
Number of adverse events
Adverse events are evaluated with CTCAE V5.0.
Time frame: During of induction treatment (4 cycles, each cycle is 28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23
Taizhou People's Hospital
Taizhou, Jiangsu, China
Yancheng First People's Hospital
Yancheng, Jiangsu, China