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OncoMatch/Clinical Trials/NCT05248633

Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Is NCT05248633 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Bortezomib and Lenalidomide for solitary plasmacytoma.

Phase 2RecruitingPeking Union Medical College HospitalNCT05248633Data as of Jun 2026Location: China

Treatment: Bortezomib · Lenalidomide · DexamethasoneSolitary 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Bortezomib

Endocrine / hormonal

Lenalidomide

Other

Dexamethasone

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 80

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

Neutrophil <1×10E9/L, hemoglobin < 8g/dL, or platelet < 75×10E9/L

Kidney function

eGFR < 40mL/min

Liver function

ALT or AST > 3 × ULN, total bilirubin > 1.5 × ULN

Cardiac function

Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment

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. Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT05248633 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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