Combining double filtration plasmapheresis with chemotherapy for multiple myeloma treatment
Clinical Research of Double Filtration Plasmapheresis Combined With Chemotherapy to Remove M Protein in Multiple Myeloma
This study is testing whether combining a special blood filtering treatment with chemotherapy can help adults with multiple myeloma feel better, especially those with kidney issues or certain protein levels.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhongnan Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04836871 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of double filtration plasmapheresis (DFPP) in conjunction with chemotherapy for patients suffering from multiple myeloma, particularly those with renal insufficiency or abnormal M protein levels. The study aims to assess how this combined approach can improve patient outcomes after conventional treatments. Eligible participants include adults diagnosed with multiple myeloma who have stable conditions and meet specific health criteria. The trial will monitor the safety and efficacy of this innovative treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with diagnosed multiple myeloma, stable after conventional treatment, and experiencing renal insufficiency or abnormal M protein.
Not a fit: Patients with severe heart disease, other organ malignancies, or active infections like tuberculosis or HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for multiple myeloma patients with renal complications.
How similar studies have performed: While the combination of DFPP and chemotherapy is a novel approach, similar studies have shown promise in improving outcomes for patients with hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Wuhan, Hubei
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.