Phase I study of weekly bortezomib for patients with recurrent or refractory multiple myeloma

Phase I study of weekly bortezomib for patients with recurrent or refractory multiple myeloma - Phase I study of weekly bortezomib for multiple myeloma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002922

Enrollment

Registered

2009-12-21

Start date

2009-10-01

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

Phase I dose-escalation trial of bortezomib which involves two cohorts. Cohort 1: bortezomib 1.3mg/m2 Cohort 2: bortezomib 1.6mg/m2 day 1,8,15,22 every five weeks, six cycles.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Relased or refractory multiple myeloma 2) Performans status 0-2 3) Normal function of major organ 4) Neuropathy: <=Grade 2 (CTCAE v3.0) 5) Written informed consent 6) Expected survival of >= 2 months

Exclusion criteria

Exclusion criteria: 1) CNS involvement 2) History of severe drug allergy 3) Active infectious diseases 4) HBs antigen or HCV antibody or HIV antibody positive 5) Significant complications which include cardiac dysfunction, liver cirrhosis, uncontrolled diabetes, renal failure 6) Interstitial pneumonitis 7) History of other active malignancy 8) Severe mental disorder

Design outcomes

Primary

Measure	Time frame
The dose-limiting toxicity of weekly bortezomib during the first cycle.	—

Secondary

Measure	Time frame
Response rate, progression-free survival, overall survival, and adverse effects.	—

Countries

Japan

Contacts

Public ContactHiroshi Kojima

Ibaraki Prefectural Central Hospital Department of Chemotherapy

h-kojima@chubyoin.pref.ibaraki.jp0296-77-1121

Outcome results

None listed

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