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Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401)

Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401) - Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000178
Enrollment
60
Registered
2005-09-12
Start date
2004-04-01
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

Therapy is composed of the following three steps of therapy. 1. induction chemotherapy(3 courses of C-VAD regimen) 2. peripheral stem cell collection after high dose cyclophosphamide 3. autologous

Sponsors

Center for Supporting Hematology-Oncology Trials (C-SHOT)
Lead Sponsor
Nagoya Muliple Myeloma Collaborated Group
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Multiple Myeloma(SWOG criteria). 2. Durie&Salomon Stage II or III. 3. No previous treatments 4. age >=16 and <= 65 5. PS 0-2(ECOG) 6. No clinically significant abnormalities in liver, heart and pulmonary functions 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe renal dysfunction 2. Severe cardiovascular dysfunction 3. Active infections 4. Active opportunistic infections 5. Active double cancers 6. Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason

Design outcomes

Primary

MeasureTime frame
Response rate after 90 days from the transplantation

Countries

Japan

Contacts

Public ContactIsamu Sugiura

Toyohashi Municipal Hospital Division of Hematology

isugiura-sgr@umin.ac.jp0532-33-6111

Outcome results

None listed

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