Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma

Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma - Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003076

Enrollment

Registered

2010-02-01

Start date

2010-02-01

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

relapsed and/or refractory multiple myeloma

Interventions

1.The case of having no neuropathy and neural pain due to peripheral neuropaty defined using NANDA bortezomib(BTZ):1.3mg/m2 intravenously day 1,8,15 of 21-day cycle cyclophosphamide(CY):50mg/body or

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.performance status:0-2 2.total WBC count>=3000/mm3, absolute neutrophil count>=1000/mm3, platelete count>=75000/mm3, Hb>=8.0g/dL 3.ATL and AST of less than 2.5 times the ULN, TB. od less than 1.5 times the ULN 4.serum creatinine less than 1.5times the ULN 5.nomal ECG 6.no interstitial pneumonitis 7.peripheral and neuropaty grade<=2 defined using NCI-CTCAE v3.0

Exclusion criteria

Exclusion criteria: performance status:3 and 4(excluding PS3 by bone pain and fracture)

Design outcomes

Primary

Measure	Time frame
safety (neurotoxixty evaluated by FACT/GOG NTX ver. 4.0)	—

Secondary

Measure	Time frame
response rate as efficacy (antitumor activity) time to response, response rate after 5 more cycles, progression free survival, overall survival	—

Countries

Japan

Contacts

Public ContactHideo Yagi

Nara Hospital Kinki University School Of Medicine Department of Hematology

0743-77-0880

Outcome results

None listed

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