Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05248633

Collaborator

(none)

220

Enrollment

Location

Arms

53.4

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Solitary Plasmacytoma	Radiation: radiotherapy Drug: Bortezomib Injection Drug: Lenalidomide Drug: Dexamethasone	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma

Actual Study Start Date :

Apr 21, 2022

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Radiotherapy	Radiation: radiotherapy radiotherapy with a dose of 40-50 Gy
Experimental: Chemotherapy combined with radiotherapy	Radiation: radiotherapy radiotherapy with a dose of 40-50 Gy Drug: Bortezomib Injection subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22 Drug: Lenalidomide Lenalidomide 25mg for 21 days Drug: Dexamethasone Dexamethasone 40mg d1,8,15,22

Arm

Intervention/Treatment

Active Comparator: Radiotherapy

Radiation: radiotherapy

radiotherapy with a dose of 40-50 Gy

Experimental: Chemotherapy combined with radiotherapy

Radiation: radiotherapy

radiotherapy with a dose of 40-50 Gy

Drug: Bortezomib Injection

subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22

Drug: Lenalidomide

Lenalidomide 25mg for 21 days

Drug: Dexamethasone

Dexamethasone 40mg d1,8,15,22

Outcome Measures

Primary Outcome Measures

event-free survival [2 years]
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 [2 years]
OS was calculated from randomization to death
response rate [2 years]
assessed according to M protein level, RECIST 1.1 and PET-CT
adverse events [collected until 30 days after treatment completion]
graded according to CTCAE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing		China

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT05248633

Other Study ID Numbers:

SP2022

First Posted:

Feb 21, 2022

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022