Multiple myeloma
Conditions
Interventions
Pd:Pomadomide combined with dexamethasone in the treatment of patients with newly diagnosed POEMS syndrome
Sponsors
Qingdao Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age: = 18 years old; 2. POEMS syndrome conforms to the following: 1) The proposed diagnostic criteria include multiple neuropathy and monoclonal immunoglobulinemia; 2) There are one of three main criteria (Castman's disease, osteosclerosis or elevated VEGF); 3) One of the six secondary criteria (organ swelling, edema, endocrine disease, skin change, nipple edema, thrombocytosis or erythrocytosis); 3. ECOG = 2 points, and the expected survival period is more than 3 months; 4. No active infectious disease; 5. The male or female who is not pregnant, not breast-feeding and may give birth agree to use appropriate methods of contraception within 4 weeks before, during, during and after treatment; 6. The main organs have no serious organic lesions (except for renal insufficiency caused by this disease), and meet the requirements of the following laboratory examination indicators (within 7 days before treatment): 1) Total bilirubin = 1.5 times the upper limit of normal value (of the same age group); 2) AST and ALT = 2 times the upper limit of normal value (at the same age); 3) Myocardial enzyme<2 times the upper limit of normal value (at the same age); 4) The cardiac ejection fraction measured by cardiac ultrasound (ECHO) is within the normal range. 7. Blood routine test within 7 days before treatment meets all the following criteria: 1) White blood cell (WBC) count = 1.5 × 10^9/L 2) Absolute neutrophil count = 1.0 × 10^9/L 3) Hemoglobin = 8.5 g/dL; 4) Platelet count = 50 × 10^9/L 8. There are follow-up conditions. The patient understood the characteristics of the disease and volunteered to join the study program for treatment and follow-up; 9. The informed consent form has been signed. The informed consent shall be signed by the patient or his immediate family. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family member shall sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients suitable for transplantation or ready for transplantation; 2. Uncontrolled active infection requiring intravenous antibiotics, antiviral drugs or antifungal drugs within 2 weeks before treatment. Oral antibiotic prophylactic treatment is acceptable within 1 week before treatment; 3. Major surgery within 4 weeks before treatment; 4. There were serious thrombotic events before treatment; 5. Unstable or active cardiovascular disease (any one is satisfied): 1) Symptomatic myocardial ischemia; 2) Clinically significant conduction abnormalities with poor control (for example, subjects with ventricular tachycardia during antiarrhythmic drug treatment will be excluded; but subjects with degree I atrioventricular block or asymptomatic left anterior bundle branch block/right bundle branch block will not be excluded); 3) Congestive heart failure or known left ventricular ejection fraction<40% with cardiac function grade = 3 of the New York Heart Association; 4) Acute myocardial infarction within 3 months before treatment. 6. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity; 7. Known active hepatitis A, B or C infection; For example, HCV RNA is positive, or HBV-DNA is positive; 8. At baseline, the body surface area (BSA) calculated by Dubois or Mostler (Mostler 1987) method is less than 1.4 m2; 9. Life expectancy<4 months; 10. Any active gastrointestinal dysfunction that may affect the ability of the subject to swallow pills, or any active gastrointestinal dysfunction that may affect the absorption of the study treatment drugs; 11. Within 5 years before randomization, there are malignant tumors that need treatment or have shown evidence of recurrence (except for non-melanoma skin cancer or fully treated cervical carcinoma in situ). Tumors that have been treated for the purpose of cure for more than 5 years and have no evidence of recurrence are allowed to be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Neurological response;Serum VEGF response;Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological reaction; | — |
Countries
China
Contacts
Public ContactYuping Zhong
Qingdao Municipal Hospital
Outcome results
None listed