Plasma-free Replacement in Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

An Efficient Method of Eliminating M Protein in Patients With Multiple Myeloma by Plasma-free Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251896
• Other study ID #: 00
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: July 2023
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• Plasma-free procedure
Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from M protein content in plasma at Week 18	M protein content in plasma	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from Blood routine in plasma at Week 18	WBC	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from Blood routine in plasma at Week 18	RBC	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from Blood routine in plasma at Week 18	PLT	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from Blood routine in plasma at Week 18	Hb	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from Blood routine in plasma at Week 18	Sodium ion	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from Blood routine in plasma at Week 18	Potassium ion	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from liver and kidney function at Week 18	eGFR	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from liver and kidney function at Week 18	Creatine	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from liver and kidney function at Week 18	ß2-MG	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from liver and kidney function at Week 18	UA	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from liver and kidney function at Week 18	ALB	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Change from liver and kidney function at Week 18	GLB	Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Primary	Adverse event: Low blood pressure	Low blood pressure	Day 1
Primary	Adverse event:	Headache	Day 1
Primary	Adverse event: Difficulty breathing	Difficulty breathing	Day 1
Primary	Adverse event: Numbness	Numbness	Day 1
Secondary	Safety and Tolerability Assess patient symptoms	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Day 0,Day 1