Phase II study of weekly irinotecan (CPT-11) for relapsed and/or refractory multiple myeloma

UMIN ID: UMIN000001213

Registered date:01/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: relapsed and/or refractory multiple myeloma after treatment with bortezomib or thalidomide (lenalidomide) in addition to the prior treatment with melphalan
• Date of first enrollment: 2008/07/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Three times administration of weekly irinotecan(CPT-11) followed by 2-week rest is repeated every four weeks for up to 8 courses.

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: progression free survival, overall survival, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) prior treatment history with irinotecan 2) serious allergic history 3) severe infection 4) diarrheae: more than 5 times a day 5) paralytic or mechanical ileus 6) massive pleural effusion or ascites 7) interstitial pneumonia, pulmonary fibrosis 8) uncontrollable diabetes mellitus 9) patients treated with warfarin 10) pregnant woman 11) symptomatic intracranial metastasis or invasion 12) psychosis 13) synchronous or metachronous malignancy 14) HBs-Ag positive or HIV-Ab positive 15) patients treated with atazanavir 16) blood infusion or G-CSF administration within 7 days 17) cardiac or gastrointestinal amyloidosis 18) inadequate to be enrolled in the protocol study

Related Information

• Primary Sponsor: Nagoya City University Hospital
• Source(s) of Monetary Support: Nagoya City University Hospital