Multiple myeloma
Conditions
Interventions
0. Determination of the Frailty score and the drug dose. 0-1. Frailty score Determine the frailty score based on age, Charlson index, ADL score, and IADL score. 0-2. Determine the drug dosages b
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Multiple myeloma patients diagnosed with IMWG criteria (2014), who are 65 or older, or autologous transplant-ineligible due to comorbidities. 2) Patients with measurable disease. 3) Laboratory data. Neutrophil > 1000/mm3 Hb > 8.0g/dL Platelet > 75000/mm3 T-Bil < 1.5x UNL AST, ALT < 3x UNL Ccr > 30mL/min 4) Performance Status: 0-2
Exclusion criteria
Exclusion criteria: 1) Smoldering or IgM myeloma, solitary plasmacytoma, plasma cell leukemia, POEMS syndrome, WM 2) CNS involvement 3) HIV+, HBs Ag+, or HCV Ab+ 4) Severe abnormality in the liver, kidney, cardiac, or pulmonary functions. Severe diabetes, hypertension, or infection. 5) Severe psychotic disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate after the completion of the induction therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Response rate (VGPR, MRD negative) after the completion of the induction therapy 2) Adverse events 3) Quality of life at the time of the enrollment, after 6 courses of the induction therapy, and after the completion of the induction therapy | — |
Countries
Japan
Contacts
Public ContactSatoshi Yoshihara
Hyogo College of Medicine Department of Transfusion Medicine and Cellular Therapy
Outcome results
None listed