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Completed

NCT Number: NCT05251896

Plasma-free Replacement in Patients With Multiple Myeloma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Plasma-free procedure

Procedure

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

Primary outcomes

  1. Change from M protein content in plasma at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    M protein content in plasma

  2. Change from Blood routine in plasma at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    WBC

  3. Change from Blood routine in plasma at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    RBC

  4. Change from Blood routine in plasma at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    PLT

  5. Change from Blood routine in plasma at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    Hb

  6. Change from Blood routine in plasma at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    Sodium ion

  7. Change from Blood routine in plasma at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    Potassium ion

  8. Change from liver and kidney function at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    eGFR

  9. Change from liver and kidney function at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    Creatine

  10. Change from liver and kidney function at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    β2-MG

  11. Change from liver and kidney function at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    UA

  12. Change from liver and kidney function at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    ALB

  13. Change from liver and kidney function at Week 18

    Time frame: Day 0,Day 1,Week 1,Week4,Week 12,Week 18

    GLB

  14. Adverse event: Low blood pressure

    Time frame: Day 1

    Low blood pressure

  15. Adverse event:

    Time frame: Day 1

    Headache

  16. Adverse event: Difficulty breathing

    Time frame: Day 1

    Difficulty breathing

  17. Adverse event: Numbness

    Time frame: Day 1

    Numbness

Secondary outcomes

  1. Safety and Tolerability Assess patient symptoms

    Time frame: Day 0,Day 1

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 23, 2022
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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