Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05248633

Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Solitary Plasmacytoma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy

Radiation

radiotherapy with a dose of 40-50 Gy

Bortezomib Injection

Drug

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

Lenalidomide

Drug

Lenalidomide 25mg for 21 days

Dexamethasone

Drug

Dexamethasone 40mg d1,8,15,22

Primary outcomes

  1. event-free survival

    Time frame: 2 years

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

Secondary outcomes

  1. overall survival

    Time frame: 2 years

    OS was calculated from randomization to death

  2. response rate

    Time frame: 2 years

    assessed according to M protein level, RECIST 1.1 and PET-CT

  3. adverse events

    Time frame: collected until 30 days after treatment completion

    graded according to CTCAE

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2022
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.