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

NCT ID: NCT06203145

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-11-30

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.

Conditions

Multiple Myeloma; Renal Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BCD-KPD-AutoHSCT

BCD-KPD-AutoHSCT/BCD-AutoHSCT

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Carfilzomib

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yujun DONG

chief of department of hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bo Tang, PhD.

Role: CONTACT

tangbo8809@163.com

008613521776195

Yujun Dong, M.D.

Role: CONTACT

dongy@hsc.pku.edu.cn

008618210264969

Facility Contacts

Yangliu Li

Role: primary

Other Identifiers

BCD-KPD-AutoHSCT of RIMM

Identifier Type: -

Identifier Source: org_study_id