Clinical trial NCT05251896: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Cancer
Plasma exchange
Plasmapheresis
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from M protein content in plasma at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from Blood routine in plasma at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from Blood routine in plasma at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from Blood routine in plasma at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from Blood routine in plasma at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from Blood routine in plasma at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from Blood routine in plasma at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from liver and kidney function at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from liver and kidney function at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from liver and kidney function at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from liver and kidney function at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from liver and kidney function at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Change from liver and kidney function at Week 18
timeFrame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
measure: Adverse event: Low blood pressure
timeFrame: Day 1
measure: Adverse event:
timeFrame: Day 1
measure: Adverse event: Difficulty breathing
timeFrame: Day 1
measure: Adverse event: Numbness
timeFrame: Day 1
Secondary outcomes:
measure: Safety and Tolerability Assess patient symptoms
timeFrame: Day 0，Day 1
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Fuling Zhou
role: STUDY_DIRECTOR
References: