NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001347

Registered date:01/09/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedmultiple myeloma
Date of first enrollment2008/09/01
Target sample size18
Countries of recruitmentJapan
Study typeInterventional
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 Outcomedefinition of recommended dose for cyclophosphamide in C-BD regimen
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteriaExclusion 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

Contact

public contact
Name Isamu Sugiura
Address Japan
Telephone
E-mail isugiura-sgr@umin.ac.jp
Affiliation Toyohashi Municipal Hospital Divsion of Hematology/Oncology
scientific contact
Name Isamu Sugiura
Address 50 Hakkennishi, Aotake-cho, Toyohashi Japan
Telephone 0532-33-6111
E-mail
Affiliation Toyohashi Municipal Hospital Divsion of Hematology/Oncology