Trial Title:
SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease
NCT ID:
NCT05900882
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Bortezomib
Conditions: Keywords:
NDMM
Extramedullary disease
SVRd
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor
Description:
Selinexor 60 mg/day, orally on d1,8,15,22
Arm group label:
study group
Other name:
S
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
Bortezomib 1.3mg/m2 intravenously on d1,8,15,22
Arm group label:
study group
Other name:
V
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide 25 mg/d (the dose will be adjusted according to creatinine clearance)
Arm group label:
study group
Other name:
R
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23
Arm group label:
study group
Other name:
d
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men and women aged with18-75 years old.
2. Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
3. Newly diagnosed patients presenting with extramedullary disease (EMD) including
solely paraskeletal plasmacytoma, plasmacytoma of soft tissue and other special
sites detected by physical exam and confirmed by CT/MRI/PET-CT and/or biopsy (≥2cm).
4. ANC≥1.0*10^9/L, HGB≥75*10^9/L, PLT≥50*10^9/L (≥50% of bone marrow nucleated cells
are plasma cells).
5. Patients whose expecting survival time will be more than 3 months.
6. Without active infectious disease.
7. Female patients of child-bearing potential must have a negative serum pregnancy test
at screening and all patients agree to use two reliable methods of contraception for
six months after their last dose of medication.
8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests and other study procedures.
9. Each patient must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study.
Exclusion Criteria:
1. Patients who have HBV, HCV, and other acquired and congenital immunodeficiency
diseases.
2. Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according
to the definition of NCI CTCAE version 4.0.
3. Plasma cell leukemia.
4. Serious thrombotic events.
5. Active, unstable cardiovascular dysfunction: a. symptomatic ischemia; b.
Uncontrolled, clinically significant conduction abnormalities (except antiarrhythmic
ventricular tachycardia), but patients with first-degree atrioventricular block or
asymptomatic left anterior bundle/right fascicular block cannot be excluded. c. New
York Heart Association (NYHA) Class III - IV or left ventricular ejection fraction
(LVEF) <40%; d. Myocardial infarction Within 3 months before C1D1.
6. Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal
(ULN)).
7. Serum bilirubin≥1.5 × ULN.
8. creatinine clearance <30 ml/min.
9. History of active malignancy during the past 5 years with the exception of basal
carcinoma of the skin or stage 0 cervical carcinoma.
10. Previous major operation within 30 days before C1D1.
11. Patients who have epilepsy, dementia requiring medication, or other mental disorders
who are unable to understand or adhere to the study protocol.
12. According to the study protocol or in the opinion of the investigator,serious
physical or mental illness that is likely to interfere with the study
procedures/results.
13. Any psychological, familial, sociological and geographical condition potentially
hampering compliance with the study protocol and follow-up schedule.
14. Current participation in another clinical trial.
15. Pregnant or lactating women.
16. Patients with other commodities that the investigators considered not suitable for
the enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changzhou Second People's Hospital
Address:
City:
Changzhou
Zip:
213000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xuzhang Lu, doctor
Phone:
15295189493
Email:
luxuzhang2008@163.com
Facility:
Name:
Nanjing First People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xuezhong Zhang, master
Phone:
18951670144
Email:
zxuezhong1968@sina.com
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuanyuan Jin, doctor
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nantong
Zip:
226001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongming Huang, Doctor
Phone:
15006281688
Email:
HHMing2008@163.com
Facility:
Name:
Taizhou People's Hospital
Address:
City:
Taizhou
Zip:
225300
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianfeng Zhu, doctor
Phone:
15996023108
Email:
zhjf248825755@sina.com
Facility:
Name:
Yancheng First People's Hospital
Address:
City:
Yancheng
Zip:
224006
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuexin Cheng, master
Phone:
15366580099
Email:
ycyycyx68@163.com
Start date:
July 15, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900882
