Solitary PlasmacytomaPhase 2NCT06863584
SBRT Plus Lenalidomide for Solitary Plasmacytoma: Phase II Trial
A Phase 2 study testing Lenalidomide (Revlimid) and SBRT in people with Solitary Plasmacytoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Solitary Plasmacytoma (SP) is a rare malignant plasma cell tumor, including Solitary Bone Plasmacytoma (SBP) and Solitary Extramedullary Plasmacytoma (SEP). Radiotherapy is the preferred treatment for SP. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solitary Plasmacytoma
- What is being tested?
- Lenalidomide (Revlimid) and SBRT
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 1 Mar 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed solitary plasmacytoma (SP).
- Age between 18 and 80 years.
- Diagnosis of SP must meet the following four criteria:
- Biopsy-confirmed plasmacytoma in bone or soft tissue. No evidence of clonal plasma cell proliferation in the bone marrow. No other lesions detected on whole-body imaging (whole-body PET-CT or MRI recommended) except for the primary solitary lesion.
- No end-organ damage caused by plasma cell disease, including SLiM CRAB [excluding bone destruction caused by the SP itself.
Who cannot join
- Patients who are not suitable for radiotherapy or unable to receive SBRT due to technical limitations, such as patients with plasmacytoma in the extremities who cannot abduct the affected limb or maintain the treatment position due to pain.
- Eastern Cooperative Oncology Group (ECOG) performance status score greater than 2.
- Patients who meet the diagnostic criteria for multiple myeloma at the time of diagnosis: bone marrow biopsy showing more than 10% plasma cells, serum calcium level above 11.5 mg/dL, serum creatinine above 2 mg/dL, creatinine clearance rate below 40 mL/min, or hemoglobin below 10 g/dL.
- Patients with uncontrolled infectious comorbidities.
- Patients with other active malignancies.
- Pregnant or breastfeeding patients.
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- Patients with a history or current pulmonary embolism.
- Patients with a history of autoimmune disease, even if it is controlled.
- Patients who are seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) DNA > 1,000 copies/mL.
- Patients with myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or severe uncontrolled arrhythmia.
- Patients with neuropathy Grade 2 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
- Patients with neutrophil count < 1×10^9/L, hemoglobin < 8 g/dL, or platelet count < 75×10^9/L.
- Patients with severely impaired liver or kidney function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN), total bilirubin > 1.5 × ULN, or estimated glomerular filtration rate (eGFR) < 40 mL/min.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang
Ting Zhang phD, +86-571-87783521, zezht@zju.edu.cn
About this study
Official title: A Phase II Trial of Stereotactic Body Radiotherapy (SBRT) With Lenalidomide Maintenance for Solitary Plasmacytoma
Solitary Plasmacytoma (SP) is a rare malignant plasma cell tumor, including Solitary Bone Plasmacytoma (SBP) and Solitary Extramedullary Plasmacytoma (SEP). Radiotherapy is the preferred treatment for SP. Although the local response rate of SP after radiotherapy is as high as 86%, 55% of patients will experience disease progression within 5 years.
Stereotactic Body Radiation Therapy (SBRT), as a new technology for "precision radiotherapy," delivers a higher dose of radiation to the tumor site through a few short treatment sessions while maintaining low-dose exposure to surrounding normal tissues. This approach achieves good local tumor control and effectively reduces radiotherapy-related side effects, making it valuable for application in SP patients. Additionally, numerous preclinical studies have confirmed that SBRT has positive immunomodulatory effects.
Read more
Based on data published in the New England Journal of Medicine in 2013, lenalidomide-based immunomodulatory therapy significantly delays the progression of symptomatic myeloma with minimal toxicity in patients with smoldering multiple myeloma.
This study aims to assess the efficacy and safety of combining SBRT with lenalidomide in patients with SP, compared to conventional intensity-modulated radiotherapy. The goal is to extend progression-free survival (PFS) in newly diagnosed SP patients, reduce adverse reactions, and improve quality of life.
- Conditions
- Solitary Plasmacytoma
- Being tested
- Lenalidomide (Revlimid), SBRT
- Keywords
- sbrt, solitary plasmacytoma, Lenalidomide
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide (Revlimid)Drug
10mg po for 21 days, followed by a 7-day rest period.
SBRTRadiation
PTV 30Gy/5f and/or PGTV 35Gy/5F.
| Study group | Role | What they receive |
|---|---|---|
| SBRT Plus Lenalidomide | Experimental | The SBRT will deliver a dose of 30Gy in 5 fractions to the planning target volume (PTV) and/or 35Gy in 5 fractions to the planning gross tumor volume (PGTV). The specific regimen will be determined based on patient's medical condition and tumor characteristics. Lenalidomide will be taken orally at a dose of 10mg, starting from the first day after the completion of radiotherapy, for 21 consecutive days, followed by a 7-day rest period. This cycle will be repeated for a total of four cycles. Receives: Drug: Lenalidomide (Revlimid); Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS measures the percentage of patients who remain free from disease progression over a five-year period.
Measured: 5 years
Secondary outcomes (1)
OS
OS was calculated from the enrollment to death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start10 Feb 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary PlasmacytomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863584
- Sponsor's protocol ID
- Y2025-0115
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Stereotactic Body Radiotherapy (SBRT) With Lenalidomide Maintenance for Solitary Plasmacytoma
- ClinicalTrials.gov ID
- NCT06863584
- Acronym / sponsor ID
- Y2025-0115
- Conditions
- Solitary Plasmacytoma
- Keywords
- sbrt, solitary plasmacytoma, Lenalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Solitary Plasmacytoma (SP) is a rare malignant plasma cell tumor, including Solitary Bone Plasmacytoma (SBP) and Solitary Extramedullary Plasmacytoma (SEP). Radiotherapy is the preferred treatment for SP. Although the local response rate of SP after radiotherapy is as high as 86%, 55% of patients will experience disease progression within 5 years.
Stereotactic Body Radiation Therapy (SBRT), as a new technology for "precision radiotherapy," delivers a higher dose of radiation to the tumor site through a few short treatment sessions while maintaining low-dose exposure to surrounding normal tissues. This approach achieves good local tumor control and effectively reduces radiotherapy-related side effects, making it valuable for application in SP patients. Additionally, numerous preclinical studies have confirmed that SBRT has positive immunomodulatory effects.
Based on data published in the New England Journal of Medicine in 2013, lenalidomide-based immunomodulatory therapy significantly delays the progression of symptomatic myeloma with minimal toxicity in patients with smoldering multiple myeloma.
This study aims to assess the efficacy and safety of combining SBRT with lenalidomide in patients with SP, compared to conventional intensity-modulated radiotherapy. The goal is to extend progression-free survival (PFS) in newly diagnosed SP patients, reduce adverse reactions, and improve quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT Plus Lenalidomide | Experimental | Drug: Lenalidomide (Revlimid), Radiation: SBRTThe SBRT will deliver a dose of 30Gy in 5 fractions to the planning target volume (PTV) and/or 35Gy in 5 fractions to the planning gross tumor volume (PGTV). The specific regimen will be determined based on patient's medical condition and tumor characteristics. Lenalidomide will be taken orally at a dose of 10mg, starting from the first day after the completion of radiotherapy, for 21 consecutive days, followed by a 7-day rest period. This cycle will be repeated for a total of four cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with newly diagnosed solitary plasmacytoma (SP).
- Age between 18 and 80 years.
- Diagnosis of SP must meet the following four criteria:
- Biopsy-confirmed plasmacytoma in bone or soft tissue. No evidence of clonal plasma cell proliferation in the bone marrow. No other lesions detected on whole-body imaging (whole-body PET-CT or MRI recommended) except for the primary solitary lesion.
- No end-organ damage caused by plasma cell disease, including SLiM CRAB [excluding bone destruction caused by the SP itself.
Key exclusion criteria (13 listed)
- Patients who are not suitable for radiotherapy or unable to receive SBRT due to technical limitations, such as patients with plasmacytoma in the extremities who cannot abduct the affected limb or maintain the treatment position due to pain.
- Eastern Cooperative Oncology Group (ECOG) performance status score greater than 2.
- Patients who meet the diagnostic criteria for multiple myeloma at the time of diagnosis: bone marrow biopsy showing more than 10% plasma cells, serum calcium level above 11.5 mg/dL, serum creatinine above 2 mg/dL, creatinine clearance rate below 40 mL/min, or hemoglobin below 10 g/dL.
- Patients with uncontrolled infectious comorbidities.
- Patients with other active malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide (Revlimid)10mg po for 21 days, followed by a 7-day rest period. | Drug | SBRT Plus Lenalidomide |
| SBRTPTV 30Gy/5f and/or PGTV 35Gy/5F. | Radiation | SBRT Plus Lenalidomide |
Primary outcome
PFS
Time frame: 5 years
PFS measures the percentage of patients who remain free from disease progression over a five-year period.
1 secondary outcome
OS
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide (Revlimid) and SBRT in people with Solitary Plasmacytoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Zhang, phD. (+86-571-87783521, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.