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Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma

Phase II study evaluating efficacy and safety of peripheral blood stem cell harvest with bortezomib for multiple myeloma - SMUIM4-MM02

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010258
Enrollment
30
Registered
2013-03-18
Start date
2013-03-18
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 (1.3 mg/m2/day) is added to the mobilization regimen on days 1, 8, and 15, in addition to high-dose cyclophosphamide (1.5 g/m2/day) given on day 1 and 2. 400 micrograms/m2/day of filgrastim

Sponsors

Fourth Department of Internal Medicine, Sapporo Medical University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Good performance status (0-2). Patients with bad performance status by the osteolytic lesions can be included. 2) Age more than 20 and less than 65 years old. 3) Main Organ function is maintained. 4) Those who are evaluated to be able to survive more than 3 months. 5) In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.

Exclusion criteria

Exclusion criteria: 1) Patients HIV-HBs-and HCV-positive. 2) Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 3) Patients with a history of active malignancy. 4) Patients with severe psychiatric disorders. 5) Patients with pregnancy or lactation. 6) Those who are considered as inappropriate to register by attending physicians.

Design outcomes

Primary

MeasureTime frame
Number of CD34 cells harvested Toxicities

Countries

Japan

Contacts

Public ContactTsutomu Sato

Sapporo Medical University Hospital Fourth Department of Internal Medicine

tsutomus@sapmed.ac.jp011-611-2111

Outcome results

None listed

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