NCT06203145

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

A Clinical Study on the Whole-course Management (BCD-KPD-AutoHSCT) Scheme for Patients With Multiple Myeloma and Kidney Injury

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma
• Renal Injury

Interventions

Type	Name	Description
DRUG	Bortezomib	A reduction in serum FLCs level of more than 80% by day 14 of BCD is defined BCD-AutoHSCT group; A reduction in serum FLCs level of less than 80% by day 14 of BCD is defined BCD-KPD-AutoHSCT group.

Timeline

• Start date: 2024-01-02
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2024-01-12
• Last updated: 2024-01-12

Locations

1 site across 1 country: China