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SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Selinexor
Bortezomib
Lenalidomide
Dexamethasone
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring NDMM, Extramedullary disease, SVRd

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women aged with18-75 years old. Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines) 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). 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). Patients whose expecting survival time will be more than 3 months. Without active infectious disease. 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. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. 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: Patients who have HBV, HCV, and other acquired and congenital immunodeficiency diseases. Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according to the definition of NCI CTCAE version 4.0. Plasma cell leukemia. Serious thrombotic events. 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. Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal (ULN)). Serum bilirubin≥1.5 × ULN. creatinine clearance <30 ml/min. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma. Previous major operation within 30 days before C1D1. Patients who have epilepsy, dementia requiring medication, or other mental disorders who are unable to understand or adhere to the study protocol. 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. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Current participation in another clinical trial. Pregnant or lactating women. Patients with other commodities that the investigators considered not suitable for the enrollment.

Sites / Locations

  • Changzhou Second People's Hospital
  • Nanjing First People's Hospital
  • The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
  • Affiliated Hospital of Nantong University
  • Taizhou People's Hospital
  • Yancheng First People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

SVRd induction treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Complete Response Rate (CR)
CR: defined as the proportion of patients who will achieve CR, as per IMWG criteria.
Duration of Response (DOR)
DOR: defined as time, in months, from initial response (PR or better) until the date of a disease progression event
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.
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.
Number of adverse events
Adverse events are evaluated with CTCAE V5.0.

Full Information

First Posted
May 29, 2023
Last Updated
August 9, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05900882
Brief Title
SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease
Official Title
An Open Label, Single Arm, Multi-Center Exploratory Study to Evaluate the Efficacy and Safety of SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
NDMM, Extramedullary disease, SVRd

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
SVRd induction treatment
Intervention Type
Drug
Intervention Name(s)
Selinexor
Other Intervention Name(s)
S
Intervention Description
Selinexor 60 mg/day, orally on d1,8,15,22
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
V
Intervention Description
Bortezomib 1.3mg/m2 intravenously on d1,8,15,22
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
R
Intervention Description
Lenalidomide 25 mg/d (the dose will be adjusted according to creatinine clearance)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
d
Intervention Description
Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23
Primary Outcome Measure Information:
Title
Number of Participants With Overall Response Rate (ORR)
Description
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)
Secondary Outcome Measure Information:
Title
Number of Participants With Complete Response Rate (CR)
Description
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)
Title
Duration of Response (DOR)
Description
DOR: defined as time, in months, from initial response (PR or better) until the date of a disease progression event
Time Frame
5 years
Title
Progression-Free Survival (PFS)
Description
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
Title
Overall Survival (OS)
Description
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
Title
Number of adverse events
Description
Adverse events are evaluated with CTCAE V5.0.
Time Frame
During of induction treatment (4 cycles, each cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged with18-75 years old. Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines) 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). 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). Patients whose expecting survival time will be more than 3 months. Without active infectious disease. 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. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. 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: Patients who have HBV, HCV, and other acquired and congenital immunodeficiency diseases. Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according to the definition of NCI CTCAE version 4.0. Plasma cell leukemia. Serious thrombotic events. 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. Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal (ULN)). Serum bilirubin≥1.5 × ULN. creatinine clearance <30 ml/min. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma. Previous major operation within 30 days before C1D1. Patients who have epilepsy, dementia requiring medication, or other mental disorders who are unable to understand or adhere to the study protocol. 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. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Current participation in another clinical trial. Pregnant or lactating women. Patients with other commodities that the investigators considered not suitable for the enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Jin, Doctor
Phone
13852295209
Email
827508088@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lijuan Chen, Doctor
Phone
15850521836
Email
chenljb@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijuan Chen
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Changzhou Second People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuzhang Lu, doctor
Phone
15295189493
Email
luxuzhang2008@163.com
Facility Name
Nanjing First People's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuezhong Zhang, master
Phone
18951670144
Email
zxuezhong1968@sina.com
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Jin, doctor
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Huang, Doctor
Phone
15006281688
Email
HHMing2008@163.com
Facility Name
Taizhou People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Zhu, doctor
Phone
15996023108
Email
zhjf248825755@sina.com
Facility Name
Yancheng First People's Hospital
City
Yancheng
State/Province
Jiangsu
ZIP/Postal Code
224006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuexin Cheng, master
Phone
15366580099
Email
ycyycyx68@163.com

12. IPD Sharing Statement

Learn more about this trial

SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease

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