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Phase II study of a BD-HDM regimen for multiple myeloma patients

Phase II study of a BD-HDM regimen for multiple myeloma patients - Bomb-MM01

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012700
Enrollment
96
Registered
2013-12-25
Start date
2013-08-20
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

Bortezomib (1 mg/m2) was administered intravenously on days -6, -3, 1, and 4. Dexamethazone (20 mg) was administered orally on days -6,-5, -3, -2, 1, 2, 4, and 5. Melphalan was administered intravenou

Sponsors

National Hospital Organization Disaster Medical Center of Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: According to the International Myeloma Working Group (IMWG) criteria20, patients younger than 65 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 at time of high-dose therapy (HDT), 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
To investigate the safety of BD-HDM before ASCTin younger Japanese patients with MM

Countries

Japan

Contacts

Public ContactYasuharu Sasaki

JCRAC Data Center

bombmm1@jcrac.ac03-5287-5121

Outcome results

None listed

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