Multiple myeloma
Conditions
Interventions
Case series:NA
Sponsors
First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Enrolled patients must meet the following criteria: 1. Newly diagnosed patients with multiple myeloma with extramedullary infiltration, meeting the following diagnostic criteria: (1) meeting the diagnostic criteria of 2014 IMWG MM; (2) the presence of extramedullary lesions in the parietal bone or other soft tissues/organs detected by imaging such as MRI or PET-CT or CT; (3) biopsy of the tissue site of the lesion to clearly identify the presence of a plasmacytoma (or the investigator's judgment based on the combination of clinical manifestations and imaging to confirm the presence of extramedullary infiltration); 2. Age: 18-70 years old; 3. Have a "measurable lesion": at least one extramedullary infiltrating lesion with a diameter of 1.0 cm or more. 4. Apply KAPd regimen induction chemotherapy with or without autologous hematopoietic stem cell transplantation treatment. 5. Patients in the prospective study sign an informed consent form indicating that the subject understands the purpose of the study and the required procedures and is willing to participate in the study;
Exclusion criteria
Exclusion criteria: (1) Previous antimyeloma therapy (excluding emergency use of radiotherapy, bisphosphonates, or single short-term hormone therapy [i.e., a dose less than or equal to dexamethasone 40 mg/day for 4 days] prior to treatment); (2) Presence of other conditions judged by the investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intramedullary/extramedullary double negative rate after 4 courses of induction therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall remission rate after 2, 4, 6, and 8 courses of treatment;Intramedullary/extramedullary double negative rate after 4 courses of induction therapy;progression-free survival, PFS;overall survival;safety profile: hematologic AE and non-hematologic AE;success rate of stem cell collection; | — |
Countries
China
Contacts
Public ContactLi Juan
First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed