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New treatment option for POEMS Syndrome
Official title KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome
ClinicalTrials.gov ID: NCT07652879
What this study is testing
What is CARFILZOMIB, CYCLOPHOSPHAMIDE, DEXAMETHASONE?
CARFILZOMIB, CYCLOPHOSPHAMIDE, DEXAMETHASONE is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for poems syndrome.
Also referred to as KCD.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-center, prospective, open-label clinical study to evaluate the efficacy and safety of KCD(Carfilzomib/Cyclophosphamide/Dexamethasone) regimen in subjects with newly diagnosed POEMS Syndrome.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Newly diagnosed POEMS syndrome meeting the Dispenzieri diagnostic criteria (2023 version);
- Age 18-75 years;
- ECOG performance status 0-3, with an estimated life expectancy \>3 months;
- No active infective diseases;
- No prior anti-POEMS therapy except for corticosteroids;
You likely can't join if
- POEMS syndrome complicated by multiple myeloma, light chain amyloidosis, or Waldenström macroglobulinemia;
- HIV positivity, or active hepatitis A, hepatitis B, or hepatitis C infection; or hepatitis B virus DNA \>10\^2 copies/mL;
- Concurrent severe unstable medical conditions, including heart failure, renal failure, liver failure, bleeding disorders, arterial/venous thrombotic...
- History of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that caused...
- Severe active infections (e.g., untreated tuberculosis, pulmonary aspergillosis);
- Presence of other malignancies (except non-melanoma skin cancer, in situ cervical, bladder, or breast cancer with disease-free survival \>5 years);
See the full eligibility criteria
- Newly diagnosed POEMS syndrome meeting the Dispenzieri diagnostic criteria (2023 version);
- Age 18-75 years;
- ECOG performance status 0-3, with an estimated life expectancy \>3 months;
- No active infective diseases;
- No prior anti-POEMS therapy except for corticosteroids;
- No severe organic impairment of major organs, meeting the following laboratory requirements: creatinine clearance ≥40 mL/min, total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN; cardiac enzymes...
- Absolute neutrophil count ≥1.5 × 10\^9/L without prior growth factor support; platelet count ≥50 × 10\^9/L without platelet transfusion within 7 days prior to screening; hemoglobin ≥60 g/L;
- Ability to swallow and take medication orally;
- Completion of all screening and assessments as outlined in the study protocol;
- Signed informed consent for chemotherapy.
- POEMS syndrome complicated by multiple myeloma, light chain amyloidosis, or Waldenström macroglobulinemia;
- HIV positivity, or active hepatitis A, hepatitis B, or hepatitis C infection; or hepatitis B virus DNA \>10\^2 copies/mL;
- Concurrent severe unstable medical conditions, including heart failure, renal failure, liver failure, bleeding disorders, arterial/venous thrombotic events within 6 months, uncontrolled diabetes mellitus, or a history...
- History of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that caused end-organ damage or required systemic immunosuppressive or disease-modifying...
- Severe active infections (e.g., untreated tuberculosis, pulmonary aspergillosis);
- Presence of other malignancies (except non-melanoma skin cancer, in situ cervical, bladder, or breast cancer with disease-free survival \>5 years);
- Epilepsy requiring medication, dementia, or other mental status abnormalities that interfere with understanding or complying with the study protocol;
- Drug use, medical, psychological, or social conditions that may interfere with study participation or outcome assessment;
- Pregnancy or breastfeeding;
- Any condition deemed by the investigator to make the patient unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.