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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203145
• Other study ID #: BCD-KPD-AutoHSCT of RIMM
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: January 2024
• Source: Peking University First Hospital
• Contact: Bo Tang, PhD.
• Phone: 008613521776195
• Email: tangbo8809[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Renal Injury

Intervention

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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal response rates		2 years