Multiple MyelomaNCT05251896
Plasma-free Replacement in Patients With Multiple Myeloma
A study testing Plasma-free procedure in people with Multiple Myeloma, run by Zhongnan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Plasma-free procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Efficient Method of Eliminating M Protein in Patients With Multiple Myeloma by Plasma-free Replacement
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.
Read the 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
- Being tested
- Plasma-free procedure
- Keywords
- Multiple Myeloma, Cancer, Plasma exchange, Plasmapheresis
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma-free procedureProcedure or surgery
Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid
| Study group | Role | What they receive |
|---|---|---|
| Plasma-free procedure | Experimental | Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid Receives: Procedure: Plasma-free procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from M protein content in plasma at Week 18
M protein content in plasma
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from Blood routine in plasma at Week 18
WBC
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from Blood routine in plasma at Week 18
RBC
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from Blood routine in plasma at Week 18
PLT
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from Blood routine in plasma at Week 18
Hb
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from Blood routine in plasma at Week 18
Sodium ion
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from Blood routine in plasma at Week 18
Potassium ion
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from liver and kidney function at Week 18
eGFR
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from liver and kidney function at Week 18
Creatine
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from liver and kidney function at Week 18
β2-MG
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from liver and kidney function at Week 18
UA
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from liver and kidney function at Week 18
ALB
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Change from liver and kidney function at Week 18
GLB
Measured: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Adverse event: Low blood pressure
Low blood pressure
Measured: Day 1
Adverse event:
Headache
Measured: Day 1
Adverse event: Difficulty breathing
Difficulty breathing
Measured: Day 1
Adverse event: Numbness
Numbness
Measured: Day 1
Secondary outcomes (1)
Safety and Tolerability Assess patient symptoms
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Day 0，Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuling Zhou, Zhongnan Hospital
- Investigators
- Fuling Zhou, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251896
- Sponsor's protocol ID
- 00
- Status last verified
- Jul 2023
- First submitted
- 23 Nov 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficient Method of Eliminating M Protein in Patients With Multiple Myeloma by Plasma-free Replacement
- ClinicalTrials.gov ID
- NCT05251896
- Acronym / sponsor ID
- 00
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Cancer, Plasma exchange, Plasmapheresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma-free procedure | Experimental | Procedure: Plasma-free procedureUse albumin solution, lactated Ringer's solution, normal saline as replacement fluid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma-free procedureUse albumin solution, lactated Ringer's solution, normal saline as replacement fluid | Procedure or surgery | Plasma-free procedure |
Primary outcome
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
Change from Blood routine in plasma at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
WBC
Change from Blood routine in plasma at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
RBC
Change from Blood routine in plasma at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
PLT
Change from Blood routine in plasma at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Hb
Change from Blood routine in plasma at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Sodium ion
Change from Blood routine in plasma at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Potassium ion
Change from liver and kidney function at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
eGFR
Change from liver and kidney function at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
Creatine
Change from liver and kidney function at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
β2-MG
Change from liver and kidney function at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
UA
Change from liver and kidney function at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
ALB
Change from liver and kidney function at Week 18
Time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18
GLB
Adverse event: Low blood pressure
Time frame: Day 1
Low blood pressure
Adverse event:
Time frame: Day 1
Headache
Adverse event: Difficulty breathing
Time frame: Day 1
Difficulty breathing
Adverse event: Numbness
Time frame: Day 1
Numbness
1 secondary outcome
Safety and Tolerability Assess patient symptoms
Time frame: Day 0，Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuling Zhou study director
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma-free procedure in people with Multiple Myeloma, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from M protein content in plasma at Week 18 (time frame: Day 0，Day 1，Week 1，Week4，Week 12，Week 18). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.