Plasma-free Replacement in Patients With Multiple Myeloma

NCT ID: NCT05251896

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-01-31

Brief Summary

To evaluate whether the technique of no plasma exchange is suitable for the treatment, clinical efficacy, safety, and suitability of multiple myeloma patients with M protein abnormality or renal failure.

Detailed Description

Multiple myeloma (MM) is the second most common hematological tumor after non-Hodgkin's lymphoma. The tumor cells originate from plasma cells in the blood pulp and are classified as plasma cells blood myeloma plasmacytomas by the WHO Tumor. It is characterized by abnormal proliferation of blood medullary plasma cells, accompanied by monoclonal immunoglobulin or light chain. Few patients are classified as non-secretory MM that does not secrete M protein. Multiple myeloma is often accompanied by multiple hemolytic damages, hypercalcemia, anemia, kidney damage, and a serious threat to the patients' lives, health, and quality of life, which have brought a heavy burden to society. Large amounts of M protein pass through the kidneys. At times, it causes acute or chronic renal failure; M protein interferes with the activity of coagulation factors, blocking platelet function, inducing bleeding; and a large amount of M protein can also lead to hyperviscosity syndrome, increase circulatory resistance, and small blood vessel thrombosis Plug, cause various neurological diseases such as blindness, and further aggravate the progression of kidney injury. Patients with hematological myeloma nephropathy already existed at the time of diagnosis, severe patients may die due to renal insufficiency, so the patient was removed immunity globulin in the body to improve the signs of hyperviscosity and clinical symptoms is the focus of clinical research.

In this study, on the basis of previous studies, albumin-free plasma exchange fluid treatment was given to analyze the effects of clinical symptoms, erythrocyte sedimentation rate, blood routine, albumin, renal function, calcium content, and immunoglobulin.

Conditions

Multiple Myeloma

Study Design

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

Study Groups

Plasma-free procedure

Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid

Group Type: EXPERIMENTAL

Plasma-free procedure

Intervention Type: PROCEDURE

Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid

Interventions

Plasma-free procedure

Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosis of MM 2. A stable condition after routine treatment 3. Clinical diagnosis of renal insufficiency or M protein abnormalities 4．more than 18 years old 5．With liver and kidney function 6. With normal heart function; 7. Physical condition score 0-2 (ECOG score) 8. Get informed consent from the patient or family member.

Exclusion Criteria

1. Allergies or obvious contraindications to any drug;

2. Myocardial infarction and cardiac insufficiency

3. Other malignant tumors

4. TB patients and HIV positive patients 5．Other blood system diseases

6. Pregnant or lactating women; 7. Not understand or follow the protocol; 8. Allergy

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

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fuling Zhou

Head,Division of Hematology; Professor of Hematology; Doctoral advisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fuling Zhou

Role: STUDY_DIRECTOR

Wuhan University

Locations

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

00

Identifier Type: -

Identifier Source: org_study_id