A clinical phase I study to define recommended dose of cyclophosphamide in combination with bortezomib and dexamethasone(C-BD) for relapsed and refractory multiple myeloma

UMIN ID: UMIN000001347

Registered date:01/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: multiple myeloma
• Date of first enrollment: 2008/09/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 1. Patients receive three 3-week treatment cycles with bortezomib(BTZ) 1.3 mg/m2 on days 1,4,8,11 combination with dexamethasone(DEX) 20 mg/m2 intravenously on days 1,2,4,5,8,9,11,12. 2. In addition, patients receive cyclophosphamide(CY)intravenously on days 1,8 at either 300, 400, 500 mg/m2 to define the recommended dose. Start dose are 300 mg/m2 and dose up with 3-cohort. 3.DLT is defined using CTCAEver3 as 1) either neutropenia (<500/mm3) or thrompocyotopenia(<25,000/mm3) 2) >=grade 3 non-hematologic toxicity except peripheral neuropathy(PN) 3) grade 3 PN which continues for more than 5 days and grade 4 PN. 4) delay to start second course for any adverse events for more than 3 weeks. 4. If no DLT in the first course, patients receive two additional courses keeping the starting dose of CY to evaluate 3 courses of combination chemotherapy for further clinical study.

Outcome(s)

• Primary Outcome: definition of recommended dose for cyclophosphamide in C-BD regimen

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria includes; 1.Cardiovascular diseases 1) Angina pectoris, and acute myocardial infarction within recent 6 months 2) congestive heart failure which requires treatment 3) arrhythmia which requires treatment 2. Respiratory diseases 1) interstitial pneumonitis 2)COPD 3)infections more than twice which in a previous year 3. infectious diseases 1) HIV infection 2) HBsAg positive 3) HBsAb and/or HBcAb posive 4) anti HCV positive 4. neuropathy 1) peripheral neuropathy grade>= 2 2) neural pain due to peripheral neuropaty 5. diabetes mellitus 6. allergy to cyclophosphamide 7.active double cancer 8.subjects who are not likely to participate in the study for any reason in the opinion of the investigator

Related Information

• Primary Sponsor: Center for Supporting Hematology-Oncology Trial(C-SHOT)
• Source(s) of Monetary Support: None