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The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.

The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients. - The efficacy and safety of sPAD

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007803
Enrollment
35
Registered
2012-04-21
Start date
2011-08-01
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

Sponsors

National Hospital Organization Disaster Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: According to the International Myeloma Working Group (IMWG) criteria, patients younger than 75 years with symptomatic MM were eligible for this trial.

Exclusion criteria

Exclusion criteria: The exclusion criteria were a serum creatinine level>2.05 mg/dL, liver dysfunction (e.g., a serum total bilirubin level>2.0 mg/dL, or serum aspartate/alanine aminotransferase or alkaline phosphatase levels more than 2.5 times the upper limit of normal), grade 3 or worse peripheral neuropathy, significant comorbidity that would preclude ASCT, poor performance status (>grade 3), and a history of any other malignancy with the exception of basal cell carcinoma and stage I cervical cancer.

Design outcomes

Primary

MeasureTime frame
efficacy

Secondary

MeasureTime frame
safety complete response rate progression free survival Blood concentration of bortezomib overall survival

Countries

Japan

Contacts

Public ContactNaoki Takaezako

National Hospital Organization Disaster Medical Center Hematology

ntakezak@tdmc.hosp.go.jp+81-42-526-5511

Outcome results

None listed

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