NCT05248633

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
5mo left

Started Apr 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Apr 2022Oct 2026

First Submitted

Initial submission to the registry

February 18, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

3.9 years

First QC Date

February 18, 2022

Last Update Submit

June 3, 2024

Conditions

Solitary Plasmacytoma

Outcome Measures

Primary Outcomes (1)

  • event-free survival

    EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.

    2 years

Secondary Outcomes (3)

  • overall survival

    2 years

  • response rate

    2 years

  • adverse events

    collected until 30 days after treatment completion

Study Arms (2)

Radiotherapy

ACTIVE COMPARATOR
Radiation: radiotherapy

Chemotherapy combined with radiotherapy

EXPERIMENTAL
Radiation: radiotherapyDrug: Bortezomib InjectionDrug: LenalidomideDrug: Dexamethasone

Interventions

radiotherapyRADIATION

radiotherapy with a dose of 40-50 Gy

Chemotherapy combined with radiotherapyRadiotherapy
Bortezomib InjectionDRUG

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

Chemotherapy combined with radiotherapy
LenalidomideDRUG

Lenalidomide 25mg for 21 days

Chemotherapy combined with radiotherapy
DexamethasoneDRUG

Dexamethasone 40mg d1,8,15,22

Chemotherapy combined with radiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • treatment-naïve SP.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

RadiotherapyBortezomibLenalidomideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2022

First Posted

February 21, 2022

Study Start

April 21, 2022

Primary Completion

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

CN(1)