multiple myeloma
Conditions
Interventions
eltrombopag combined with CP regimen:none
CP regimen:none
Sponsors
Zhabei Central Hospital, Jing 'an District, Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Be aware of and voluntarily sign the informed consent form (ICF). 2. Age = 18 years. 3. Diagnosed with multiple myeloma (MM) according to IMWG criteria, with measurable lesions, meeting at least one of the following criteria: serum M protein = 0.5g/dL (=5g/L) as detected by serum protein electrophoresis (SPEP), or if IgA or IgD type myeloma, urine M protein level can be replaced by quantitative levels of IgA or lgD = 200mg/24 hours when there is abnormal serum free light chain (FLC) ratio, serum FLC = 100mg/L (normal FLC ratio: 0.26 to 1.65). 4. Imaging suggests at least one bone lesion related to myeloma. 5. Previously received at least third-line or higher anti-MM treatment (including proteasome inhibitors and immunomodulatory agents). Induction followed by stem cell transplantation and consolidation/maintenance therapy are considered as one anti-MM treatment regimen. 6. Clear evidence of MM progression during or after the last treatment regimen as determined by the investigator based on IMWG criteria. 7. ECOG performance status score of 0, 1, 2, 3, or 4. 8. Platelet count <50×10^9/L. 9.Liver function: total bilirubin <1.5× upper limit of normal (ULN), aspartate aminotransferase(AST) and alanine aminotransferase(ALT)<2×ULN. 10.Any clinically significant non-hematologic toxicity caused by previous treatment has regressed to grade <1 or stabilized at chronic grade-2 toxicity prior to enrollment under medical monitor approval. 11.Female subjects capable of reproduction must have negative pregnancy test results in their serum samples.The female subjects capable of reproduction and male subjects must use highly effective contraception methods throughout the study period and for three months after the last study treatment session
Exclusion criteria
Exclusion criteria: 1. Active plasma cell leukemia. 2. Diagnosed systemic light chain amyloidosis. 3. Multiple myeloma involving the central nervous system. 4. POEMS syndrome. 5. Presence of spinal cord compression related to multiple myeloma. 6. Concurrent active graft-versus-host disease during screening (after allogeneic stem cell transplantation). 7. Coexistence with uncontrolled other malignancies. 8. Pregnant or lactating women. 9. Currently suffering from thrombotic diseases such as pulmonary embolism or venous thrombosis. 10. Any active gastrointestinal dysfunction that affects the subject's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of study treatment drugs. 11.Any active severe mental illness, medical condition, or other symptoms/conditions that may affect treatment, compliance, or capacity to provide informed consent in the study 12.Contraindications to any prescribed drug therapy in the protocol 13.Any disease or complication that may interfere with study procedures 14.Autologous stem cell transplantation within <1 month prior to treatment initiation or allogeneic stem cell transplantation within <4 months prior to treatment initiation 15.Subjects on long-term corticosteroid therapy during screening do not require a washout period but must be able to tolerate the specified doses in this study 16.Subject unwillingness or inability to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactFan Zhou
Zhabei Central Hospital, Jing 'an District, Shanghai
Outcome results
None listed