Solitary PlasmacytomaPhase 2NCT05248633
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
A Phase 2 study testing radiotherapy, Bortezomib Injection and Lenalidomide in people with Solitary Plasmacytoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. 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?
- radiotherapy, Bortezomib Injection and Lenalidomide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2022to Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- treatment-naïve SP.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Jian Li, 010-69155020, lijian@pumch.cn
About this study
Official title: Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed 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.
- Conditions
- Solitary Plasmacytoma
- Being tested
- radiotherapy, Bortezomib Injection, Lenalidomide, Dexamethasone
- 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.
radiotherapyRadiation
radiotherapy with a dose of 40-50 Gy
Bortezomib InjectionDrug
subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22
LenalidomideDrug
Lenalidomide 25mg for 21 days
DexamethasoneDrug
Dexamethasone 40mg d1,8,15,22
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Active comparator | Not described Receives: Radiation: radiotherapy |
| Chemotherapy combined with radiotherapy | Experimental | Not described Receives: Radiation: radiotherapy; Drug: Bortezomib Injection; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival
EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.
Measured: 2 years
Secondary outcomes (3)
overall survival
OS was calculated from randomization to death
Measured: 2 years
response rate
assessed according to M protein level, RECIST 1.1 and PET-CT
Measured: 2 years
adverse events
graded according to CTCAE
Measured: collected until 30 days after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start21 Apr 2022
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (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 Peking Union Medical College HospitalThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248633
- Sponsor's protocol ID
- SP2022
- Status last verified
- Jun 2024
- First submitted
- 18 Feb 2022
- Last updated
- 5 Jun 2024
- 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma
- ClinicalTrials.gov ID
- NCT05248633
- Acronym / sponsor ID
- SP2022
- Conditions
- Solitary Plasmacytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Feb 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Active comparator | Radiation: radiotherapy |
| Chemotherapy combined with radiotherapy | Experimental | Radiation: radiotherapy, Drug: Bortezomib Injection, Drug: Lenalidomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- treatment-naïve SP.
Key exclusion criteria (12 listed)
- Not appropriate for radiotherapy.
- ECOG > 2.
- Co-morbidity of uncontrolled infection.
- Co-morbidity of other active malignancy.
- Patients in pregnancy or lactation.
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 |
|---|---|---|
| radiotherapyradiotherapy with a dose of 40-50 Gy | Radiation | Chemotherapy combined with radiotherapy, Radiotherapy |
| Bortezomib Injectionsubcutaneous Bortezomib 1.3mg/m2 d1,8,15,22 | Drug | Chemotherapy combined with radiotherapy |
| LenalidomideLenalidomide 25mg for 21 days | Drug | Chemotherapy combined with radiotherapy |
| DexamethasoneDexamethasone 40mg d1,8,15,22 | Drug | Chemotherapy combined with radiotherapy |
Primary outcome
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.
3 secondary outcomes
overall survival
Time frame: 2 years
response rate
Time frame: 2 years
adverse events
Time frame: collected until 30 days after treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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. This study is not recruiting at the moment.
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 radiotherapy, Bortezomib Injection and Lenalidomide in people with Solitary Plasmacytoma, run by Peking Union Medical College Hospital 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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event-free survival (time frame: 2 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 5 Jun 2024.