Back to resultsChemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Primary Purpose
Solitary Plasmacytoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
radiotherapy
Bortezomib Injection
Lenalidomide
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Solitary Plasmacytoma
Eligibility Criteria
Inclusion Criteria:
- treatment-naïve SP.
Exclusion Criteria:
- Not appropriate for radiotherapy.
- ECOG > 2.
- Co-morbidity of uncontrolled infection.
- Co-morbidity of other active malignancy.
- Patients in pregnancy or lactation.
- Prior or concurrent pulmonary embolism.
- Patients not able to tolerate thrombosis prophylaxis, bortezomib, lenalidomide or dexamethasone.
- Seropositive for human immunodeficiency virus, seropositive for hepatitis C, or HBV-DNA > 1000 copies/mL.
- Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.
- Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
- Neutrophil <1×10E9/L，hemoglobin < 8g/dL，or platelet < 75×10E9/L.
- Severely compromised hepatic or renal function: ALT or AST > 3 × ULN, total bilirubin > 1.5 × ULN，or eGFR < 40mL/min.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radiotherapy
Chemotherapy combined with radiotherapy
Arm Description
Outcomes
Primary Outcome Measures
event-free survival
EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.
Secondary Outcome Measures
overall survival
OS was calculated from randomization to death
response rate
assessed according to M protein level, RECIST 1.1 and PET-CT
adverse events
graded according to CTCAE
Full Information
NCT ID
NCT05248633
First Posted
February 18, 2022
Last Updated
April 22, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05248633
Brief Title
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Official Title
Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Solitary plasmacytoma (SP) is characterized by a localized mass of clonal plasma cells with no or minimal bone marrow plasmacytosis. It can present either as EMP or SBP. Radiotherapy is the first-line treatment with high response rate. However, 65-84% SBP patients and 25-35% EMP patients progress at 10 years. We aimed to investigate whether adjuvant bortezomib based chemotherapy with radiotherapy could prolong event-free survival in treatment-naive SP patients compared to that with radiotherapy alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Plasmacytoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy
Arm Type
Active Comparator
Arm Title
Chemotherapy combined with radiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
radiotherapy with a dose of 40-50 Gy
Intervention Type
Drug
Intervention Name(s)
Bortezomib Injection
Intervention Description
subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide 25mg for 21 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 40mg d1,8,15,22
Primary Outcome Measure Information:
Title
event-free survival
Description
EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival
Description
OS was calculated from randomization to death
Time Frame
2 years
Title
response rate
Description
assessed according to M protein level, RECIST 1.1 and PET-CT
Time Frame
2 years
Title
adverse events
Description
graded according to CTCAE
Time Frame
collected until 30 days after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
treatment-naïve SP.
Exclusion Criteria:
Not appropriate for radiotherapy.
ECOG > 2.
Co-morbidity of uncontrolled infection.
Co-morbidity of other active malignancy.
Patients in pregnancy or lactation.
Prior or concurrent pulmonary embolism.
Patients not able to tolerate thrombosis prophylaxis, bortezomib, lenalidomide or dexamethasone.
Seropositive for human immunodeficiency virus, seropositive for hepatitis C, or HBV-DNA > 1000 copies/mL.
Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.
Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
Neutrophil <1×10E9/L，hemoglobin < 8g/dL，or platelet < 75×10E9/L.
Severely compromised hepatic or renal function: ALT or AST > 3 × ULN, total bilirubin > 1.5 × ULN，or eGFR < 40mL/min.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Li
Phone
010-69155020
Email
lijian@pumch.cn
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
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