Refractory/Relapsed Multiple Myeloma
Conditions
Interventions
Tset group:All-trans Retinoic Acid plus the KPD Regimen
Sponsors
The First Aiffiliated hosptical of xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Subjects must have a diagnosis of multiple myeloma based on the following criteria: (1) Monoclonal plasma cells in the bone marrow in =10% of patients at some point in time when the presence of plasmacytoma is confirmed by disease history or biopsy. (2) Measurable disease is defined as follows: Serum monoclonal gammaglobulin (M protein) level = 5 g/L; or urinary M protein level = 200 mg/24 hours; or serum immunoglobulin free light chain = 100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kap/lam light chain ratio. 3. Diagnosis of refractory/relapsed multiple myeloma: (1) Relapse is defined as the progression of disease after an initial response (=MR) to prior therapy 60 days after cessation of therapy. (2) Refractory disease is defined as a <25% reduction in M protein or disease progression during treatment or within 60 days of stopping treatment. 4. ECOG assessment of 0, 1, or 2. 5. Life expectancy of at least 3 months. 6. The patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Patient who currently participating or planning to participate in any interventional clinical study. 2. The investigator considers the patient unsuitable for participation in this study. 3. Non-secretory myeloma. 4. Subjects have received antimyeloma therapy within 2 weeks or 5 pharmacokinetic half-lives, whichever is longer, prior to initiation of treatment. This includes subjects who received a cumulative dose of corticosteroids greater than or equal to a 140 mg prednisone equivalent dose or a single dose of corticosteroids greater than or equal to a 40 mg/day dexamethasone equivalent dose within 2 weeks prior to initiation of treatment. 5. Subjects who have previously received an allogeneic stem cell transplant within 1 year prior to the date of enrollment and have not used immunosuppressive medications within 1 month prior to the date of enrollment. 6. Inadequate bone marrow reserve as defined by a platelet count 470 ms. 9. Severe hepatic dysfunction (total bilirubin 3 times normal or transaminases 3 times normal) unless associated with myeloma. 10. Creatinine clearance <20 mL/min. 11. Known allergy to components of the test product, or severe allergy or hypersensitivity to humanized products. 12. The subject has a concurrent serious and/or uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, infections, hypertension, etc.) that may interfere with the study procedures or results or that, in the opinion of the investigator, may pose a risk to participation in this study. 13. Subjects known to be seropositive for human immunodeficiency virus (HIV) or have active hepatitis B or C. 14. History of active malignancy within the past 5 years, except squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or cured within 5 years with minimal risk of recurrence in the opinion of the local investigator, in agreement with the principal investigator. 15. Subjects known or suspected of not being able to comply with the study protocol (e.g. due to alcoholism, drug dependence, or psychological disorders), or the subject has any condition that, in the investigator's belief that participation would not be in the subject's best
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhijuan Lin
The first affiliated hospital of Xiamen University
Outcome results
None listed