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

UMIN ID: UMIN000003345

Registered date:17/03/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 2010/05/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Eight cycles of bortezomib (1.3 mg/m2) + dexamethasone (20 mg/body) therapy on days 1, 8, and 15 in every 4 weeks

Outcome(s)

• Primary Outcome: Best response rate
• Secondary Outcome: Safety Completion rate Progression free survival Overall survival

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude 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)

Related Information

• Primary Sponsor: Japan myeloma study group
• Source(s) of Monetary Support: None
• Secondary ID(s): JMSG-0902