Safety and Efficacy of Bortezomib inaddtion to Adriamycin and Intermediate-Dose Dexamethasone (iPAD) in Subjects with Relapse/Refractory Multiple Myeloma with Primary Therapies ; A PhaseI/II, Multicentre, Open-Label, Single-Arm Study

UMIN ID: UMIN000001210

Registered date:26/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Relapse/Refractory Multiple Myeloma
• Date of first enrollment: 2008/05/01
• Target sample size: 28
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Bortezomib 1.0 mg/m2 or 1.3 mg/m2 on Days 1, 4, 8, and 11, IV Doxorubicin 9 mg/m2 on Day 1 to 4 IV Dexamethasone 20 mg daily on Days 1 to 2, 4 to 5, 8 to 9, and 11 to 12, orally Each cycle consist of 21-day treatment.

Outcome(s)

• Primary Outcome: Safety Complete remission rate
• Secondary Outcome: PR rate PFS Time to response OS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.Use of bortezomib in the previous treatment. 2.History of allergic reactions to compounds containing mannitol, bortezomib, or boron 3.Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to study protocol. 4.Active infection requiring treatment 5.Active hepatitis B or C. 6.Under treatment for a cancer other than multiple myeloma 7.Impaired kidney function requiring dialysis, liver function, cardiac function or pulmonary function. 8.Non-secretory myeloma, plasmacytoma, plasma cell leukemia, and POEMS syndrome. 9.Peripheral neuropathy> grade 2 10.Pregnant, lactation or potential

Related Information

• Primary Sponsor: Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine, Fukuoka University
• Source(s) of Monetary Support: Non profit organization Clinical Hematology Oncology Study Group