Multiple Myeloma
Conditions
Interventions
lafutidine was administered orally at a dose of 10 mg twice a day from the first course to the forth course of chemotherapy with Bortezomib.
Sponsors
Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as Multiple myeloma and indicated for chemotherapy that contains bortezomib. (1.3mg/m2) 2. Patients indicated for administration of H2-receptor antagonist or proton pump inhibitors. 3. Patients older than 20 years 4. Patients without severe liver failure( AST or ALT is greater than three times the upper limit of normal) and kidney failure(estimated EGFR is less than 50ml / min) 5. Patients with performance status 0-2 6. Patients accepted the participation for this study after full explanation and understanding of the content s of this study
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity reaction for lafutidine 2. Patients with active disease except for multiple myeloma. 3. Patients with peripheral neuropathy. 4. Patients with oral drugs that affect the neurological disorder.(Methylcobalamin, Anticonvulsants(Pregabalin, Gabapentin , Carbamazepine) , Tricyclic antidepressants( Amitriptyline, Nortriptyline, Amoxapine) ,Serotonin and norepinephrine reuptake inhibitors(Duloxetine), Antiarrhythmic drugs(Mexiletine, Flecainide) , Goshajinkigan, Shakuyakukanzoutou, etc.) 5. The patients who are receiving H2 antagonist or proton pump inhibitors, and who cannot stop these drugs. 6. Patients who require administration of Intrathecal chemotherapy. 7. Patients with severe hypersensitivity reaction for any medications. 8. Patients with HIV infection 9. Pregnant women. 10. Breast feeding women. 11. Patients who considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 12. Patients who do not agree with his or her intention 13. Patients whom the doctor recognizes unsuitable subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the incidence of peripheral neuropathy grade 1 with neuropathic pain and grater than Grade2 as graded by the CTCAE v. 4.0 criteria. | — |
Countries
Japan
Contacts
Public ContactKenji Oritani
Osaka University Graduate School of Medicine Department of Hematology and Oncology
Outcome results
None listed