Multiple MyelomaPhase 1NCT04836871
Double Filtration Plasmapheresis Combined With Chemotherapy
A Phase 1 study testing DFPP combined with chemotherapy in people with Multiple Myeloma, run by Fuling Zhou at 1 site in China.
Trial summary
Evaluation of double filtration plasmapheresis combined with chemotherapy for the treatment of abnormalities of M protein or renal function due to the multiple myeloma. 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?
- DFPP combined with chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2021to 31 Oct 2024
- Phase
- Phase 1
- 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
- Multiple myeloma patients who are diagnosed by bone marrow morphology and immunology
- Patients with stable condition after conventional treatment
- Patients with renal insufficiency or abnormal M protein
- Patients over 18 years of age
- Liver function: blood bilirubin ≤ 35μmol/L, enzymes aspartate transaminase (AST)/aka alanine aminotransferase (ALT) is less than 2 times the upper limit of normal
- Normal heart function
- Physical condition score 0-2 level (ECOG score)
- Obtain an informed consent form signed by the patient or family member
Who cannot join
- Allergies or obvious contraindications to any of the drugs involved in the plan
- Severe heart disease, including myocardial infarction and cardiac insufficiency.
- Suffering from other organ malignancies
- Active tuberculosis patients and HIV-positive patients
- At the same time suffering from other blood system diseases
- Pregnant or lactating women
Show all 11Show fewer
- Able to understand or follow the research plan
- Past history of intolerance or allergy to similar drugs
- Patients under 18 years of age
- Participating in other clinical researchers at the same time
- There are any other circumstances that hinder the progress of the research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Fuling Zhou, director, +86-02767813137, zhoufuling@163.com
About this study
Official title: Clinical Research of Double Filtration Plasmapheresis Combined With Chemotherapy to Remove M Protein in Multiple Myeloma
Evaluation of double filtration plasmapheresis combined with chemotherapy for the treatment of abnormalities of M protein or renal function due to the multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- DFPP combined with chemotherapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFPP combined with chemotherapyCombination product
Double filtration plasmapheresis combined with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Double filtration plasmapheresis (DFPP) combined with chemotherapy | Experimental | Not described Receives: Combination Product: DFPP combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
M protein clearance rate
before each treatment of Double filtration plasmapheresis (DFPP)
Measured: 1hour
M protein clearance rate
after each treatment of DFPP
Measured: 1hour
creatinine clearance rate
before each treatment of DFPP
Measured: 1hour
creatinine clearance rate
after each treatment of DFPP
Measured: 1hour
albumin concentration
before each treatment of DFPP
Measured: 1hour
albumin concentration
after each treatment of DFPP
Measured: 1hour
serum-free light chain levels
before each treatment of DFPP
Measured: 1hour
serum-free light chain levels
after each treatment of DFPP
Measured: 1hour
blood urea nitrogen
before each treatment of DFPP
Measured: 1hour
blood urea nitrogen
after each treatment of DFPP
Measured: 1hour
Platelet concentrations
before each treatment of DFPP
Measured: 1hour
Platelet concentrations
after each treatment of DFPP
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 May 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuling Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fuling Zhou, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836871
- Sponsor's protocol ID
- 01
- Status last verified
- Jul 2023
- First submitted
- 7 Mar 2021
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Double Filtration Plasmapheresis Combined With Chemotherapy to Remove M Protein in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04836871
- Acronym / sponsor ID
- 01
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fuling ZhouUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 8 Apr 2021 (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.
Evaluation of double filtration plasmapheresis combined with chemotherapy for the treatment of abnormalities of M protein or renal function due to the multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double filtration plasmapheresis (DFPP) combined with chemotherapy | Experimental | Combination Product: DFPP combined with chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Multiple myeloma patients who are diagnosed by bone marrow morphology and immunology
- Patients with stable condition after conventional treatment
- Patients with renal insufficiency or abnormal M protein
- Patients over 18 years of age
- Liver function: blood bilirubin ≤ 35μmol/L, enzymes aspartate transaminase (AST)/aka alanine aminotransferase (ALT) is less than 2 times the upper limit of normal
Key exclusion criteria (11 listed)
- Allergies or obvious contraindications to any of the drugs involved in the plan
- Severe heart disease, including myocardial infarction and cardiac insufficiency.
- Suffering from other organ malignancies
- Active tuberculosis patients and HIV-positive patients
- At the same time suffering from other blood system diseases
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 |
|---|---|---|
| DFPP combined with chemotherapyDouble filtration plasmapheresis combined with chemotherapy | Combination product | Double filtration plasmapheresis (DFPP) combined with chemotherapy |
Primary outcome
M protein clearance rate
Time frame: 1hour
before each treatment of Double filtration plasmapheresis (DFPP)
M protein clearance rate
Time frame: 1hour
after each treatment of DFPP
creatinine clearance rate
Time frame: 1hour
before each treatment of DFPP
creatinine clearance rate
Time frame: 1hour
after each treatment of DFPP
albumin concentration
Time frame: 1hour
before each treatment of DFPP
albumin concentration
Time frame: 1hour
after each treatment of DFPP
serum-free light chain levels
Time frame: 1hour
before each treatment of DFPP
serum-free light chain levels
Time frame: 1hour
after each treatment of DFPP
blood urea nitrogen
Time frame: 1hour
before each treatment of DFPP
blood urea nitrogen
Time frame: 1hour
after each treatment of DFPP
Platelet concentrations
Time frame: 1hour
before each treatment of DFPP
Platelet concentrations
Time frame: 1hour
after each treatment of DFPP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DFPP combined with chemotherapy in people with Multiple Myeloma, run by Fuling Zhou 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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M protein clearance rate (time frame: 1hour). The study lists 12 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 13 Jul 2023.