multiple myeloma
Conditions
Interventions
None listed
Sponsors
Division of Hematology, Department of Medicine, Keio University, School of Meidicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with multiple myeloma currently visiting or admitting in Keio University Hospital and plan to receive weekly bortezomib + dexamethasone therapy. Those who do not receive prior chemotherapy except for dexamethasone or zoleedronic acid are included.
Exclusion criteria
Exclusion criteria: 1) Patients without consent 2) Patients with PS 3 or worse 3) ANC < 1,000/cmm 4) AST > or = 3 x upper limit, ALT > or = 3 x upper limit, TB > or = 2 x upper limit 5) Interstitial pneumonia diagnosed by imaging, pulmonary function test, or blood examination. Patients with increased level of KL-6 without any other findings suspicious of interstitial pneumonia are included. 6) Peripheral neuropathy grade 3 or higher 7) Drug allergy against bortezomib or dexamethasone 8) Primary physician thinks it is inappropriate to enroll the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (VGPR + CR + sCR) to bortezomib + dexamethasone at the end of 2nd and 4th course of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, OS Incidence of adverse events at the end of 2nd and 4th course of treatment. Adverse events are evaluated according to NCI CTCAE ver 4. Peripheral neuropathy is also evaluated based on the modified FACT/GOG-NTx scale | — |
Countries
Japan
Contacts
Public ContactNorisato Hashimoto
Keio University, School of Meidicine Division of Hematology, Department of Medicine
Outcome results
None listed