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

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 - A phase I study of combination with cyclophosphamide, bortezomib and dexamethasone for relapsed and refractory multiple myeloma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001347

Enrollment

Registered

2008-09-01

Start date

2008-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma

Interventions

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,

500/mm3) or thrompocyotopenia(&lt

25,000/mm3) 2) &gt

=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 mor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibilty criteria includes; 1.relapsed, refractory multiple myeloma 2. age 20-69 3. PS(ECOG): 0 and 1 4. No chemotherapy for more than 3 weeks since previous chetherapy. 5. A total WBC count >=3000/mm3, absolute neutrophil count >= 1500/mm3, Platelete count >=75000/mm3. 6. ALT of less than 2.5 times the ULN, TB .of less than 1.5 times the ULN. 7. serum creatinine less than 2 times the ULN 8. Left Ventricular Ejection Fraction >= 50% 9. SaO2 >=92% 10. Having measurable diseases of serum M-protein >=1g/dL or 24hrs urine M-protein >=200 mg 11. Giving written informed consent before entering the study

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
definition of recommended dose for cyclophosphamide in C-BD regimen	—

Countries

Japan

Contacts

Public ContactIsamu Sugiura

Toyohashi Municipal Hospital Divsion of Hematology/Oncology

isugiura-sgr@umin.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026