A Clinical Study on the Whole-course Management (BCD-KPD-AutoHSCT) Scheme for Patients With RIMM

Not Applicable

Recruiting

• Conditions: Renal Injury; Multiple Myeloma
• Interventions: Drug: Bortezomib

• Registration Number: NCT06203145
• Lead Sponsor: Peking University First Hospital

Brief Summary

Multiple myeloma (MM) is still an incurable hematological tumor, and renal involvement is the main factor of poor prognosis. The recovery of renal function can partially reverse its poor outcome. Although the 5-year survival rate of MM patients has significantly improved after entering the era of new drugs, patients with severe renal insufficiency still have a high early mortality.The purpose of this study is to investigate whether early intensive chemotherapy can reverse the proportion of renal insufficiency, is to investigate the treatment effect of RIMM patients with different renal pathological types, and is also to investigate whether autoHSCT can further partially save renal function in RIMM patients.

Detailed Description

For patients with multiple myeloma with renal impairment, the same disease stage and the same treatment regimen have different therapeutic effects. In the era of new drugs, studies have shown that early reduction of the free light chain in serum is the key to reversing renal function. The International Myeloma Working Group recommends the following drugs for the treatment of RIMM patients: 1. regimens based on proteasome inhibitors; 2. regimens based on immunomodulators. Here, we explore a clinical study on the Whole-course Management (BCD-KPD-AutoHSCT) scheme for patients with RIMM.

Study Timeline

• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study Start: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adults aged 18 years or older
2. Confirmed diagnosis of symptomatic myeloma with renal impairment
3. Confirmed myeloma-associated nephropathy (e.g. light chain cast nephropathy, AL amyloidosis, MIDD etc.) on renal biopsy
4. Willingness and eligibility for autologous hematopoietic stem cell transplantation

Exclusion Criteria

1. Pre-existing chronic kidney disease unrelated to myeloma, such as diabetic nephropathy or hypertensive nephropathy
2. Plasma cell leukemia or extramedullary plasmacytoma
3. Contraindications or prior severe allergic reactions to study medications
4. Co-existing malignancy
5. Co-existing medical conditions unsuitable for enrollment as determined by researchers, such as recent cardiovascular event, active infection etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCD-KPD-AutoHSCT	Bortezomib	BCD-KPD-AutoHSCT/BCD-AutoHSCT

Primary Outcome Measures

Name	Time	Method
renal response rates	2 years

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China