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

NCT06203145 | Unknown

• 1 other identifier: BCD-KPD-AutoHSCT of RIMM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Renal Injury

Outcome Measures

Primary Outcomes (1)

• renal response rates

  2 years

Study Arms (1)

BCD-KPD-AutoHSCT

EXPERIMENTAL

BCD-KPD-AutoHSCT/BCD-AutoHSCT

Drug: Bortezomib

Interventions

Bortezomib 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.

Also known as: Carfilzomib

BCD-KPD-AutoHSCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Bo Tang, PhD.

CONTACT

008613521776195; tangbo8809@163.com

Yujun Dong, M.D.

CONTACT

008618210264969; dongy@hsc.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of department of hematology

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 12, 2024
• Study Start: January 2, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

CN (1)