Plasma-free Replacement in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Plasma-free procedure
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Cancer, Plasma exchange, Plasmapheresis
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:
- Allergies or obvious contraindications to any drug;
- Myocardial infarction and cardiac insufficiency
- Other malignant tumors
- 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
Sites / Locations
- Zhongnan Hospital of Wuhan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plasma-free procedure
Arm Description
Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid
Outcomes
Primary Outcome Measures
Change from M protein content in plasma at Week 18
M protein content in plasma
Change from Blood routine in plasma at Week 18
WBC
Change from Blood routine in plasma at Week 18
RBC
Change from Blood routine in plasma at Week 18
PLT
Change from Blood routine in plasma at Week 18
Hb
Change from Blood routine in plasma at Week 18
Sodium ion
Change from Blood routine in plasma at Week 18
Potassium ion
Change from liver and kidney function at Week 18
eGFR
Change from liver and kidney function at Week 18
Creatine
Change from liver and kidney function at Week 18
β2-MG
Change from liver and kidney function at Week 18
UA
Change from liver and kidney function at Week 18
ALB
Change from liver and kidney function at Week 18
GLB
Adverse event: Low blood pressure
Low blood pressure
Adverse event:
Headache
Adverse event: Difficulty breathing
Difficulty breathing
Adverse event: Numbness
Numbness
Secondary Outcome Measures
Safety and Tolerability Assess patient symptoms
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05251896
Brief Title
Plasma-free Replacement in Patients With Multiple Myeloma
Official Title
An Efficient Method of Eliminating M Protein in Patients With Multiple Myeloma by Plasma-free Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Cancer, Plasma exchange, Plasmapheresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasma-free procedure
Arm Type
Experimental
Arm Description
Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid
Intervention Type
Procedure
Intervention Name(s)
Plasma-free procedure
Intervention Description
Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid
Primary Outcome Measure Information:
Title
Change from M protein content in plasma at Week 18
Description
M protein content in plasma
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from Blood routine in plasma at Week 18
Description
WBC
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from Blood routine in plasma at Week 18
Description
RBC
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from Blood routine in plasma at Week 18
Description
PLT
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from Blood routine in plasma at Week 18
Description
Hb
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from Blood routine in plasma at Week 18
Description
Sodium ion
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from Blood routine in plasma at Week 18
Description
Potassium ion
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from liver and kidney function at Week 18
Description
eGFR
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from liver and kidney function at Week 18
Description
Creatine
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from liver and kidney function at Week 18
Description
β2-MG
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from liver and kidney function at Week 18
Description
UA
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from liver and kidney function at Week 18
Description
ALB
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Change from liver and kidney function at Week 18
Description
GLB
Time Frame
Day 0,Day 1,Week 1,Week4,Week 12,Week 18
Title
Adverse event: Low blood pressure
Description
Low blood pressure
Time Frame
Day 1
Title
Adverse event:
Description
Headache
Time Frame
Day 1
Title
Adverse event: Difficulty breathing
Description
Difficulty breathing
Time Frame
Day 1
Title
Adverse event: Numbness
Description
Numbness
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Safety and Tolerability Assess patient symptoms
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Day 0,Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
Allergies or obvious contraindications to any drug;
Myocardial infarction and cardiac insufficiency
Other malignant tumors
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuling Zhou
Organizational Affiliation
Wuhan University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
12. IPD Sharing Statement
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Plasma-free Replacement in Patients With Multiple Myeloma
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