Weekly bortezomib + dexamethasone therapy for elderly patients with relapsed or refractory multiple myeloma (A multicenter clinical phase II trial, JMSG-0902)

Phase 2

• Conditions: Multiple myeloma

• Registration Number: JPRN-UMIN000003345
• Lead Sponsor: Japan myeloma study group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Study Completion: 2017-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1) Previous history of hypersensitivity for Bortezomib, dexamethasone, mannitol or boron 2) Non-secretary myeloma or plasma cell leukemia 3) Peripheral neuropathy (>=grade 2) 4) Positive for HIV antibody, HBs antigen, or HCV antibody. Patients with HTLV-1 antibody can be included. 5) Uncontrollable condition of liver dysfunction, renal dysfunction, heart failure, pulmonary failure, diabetes mellitus, hypertension, or infectious disease. 6) Active and progressive double cancer within 5 years (cured carcinoma in situ either the stomach, the large intestine, or the cervical uterus are excluded from double cancer). 7) Serious mental illness such as schizophrenia 8) Pregnant woman or possibility of getting pregnant, breast-feeding 9) Interstitial pneumonitis or lung fibrosis by the clinical findings, abnormal shadow of high-resolution chest CT, high levels of KL-6, SP-A, or SP-D 10) Others (inappropriate case)

Study & Design

• Study Type: Interventional
• Study Design: Not specified