Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)

Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403) - Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000168

Enrollment

Registered

2005-09-12

Start date

2004-08-01

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 that refractory or relapsed for autologous stem cell transplantation

Interventions

Non-myeloablative conditioning of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Refractory(except for CR and vPR) or relapse for autologus stem cell transplantation 2) Aged 20 to 65 years 3) HLA matched sibling donor 4) ECOG PS 0-2 5) Sufficient organ function 6) Written informed concent

Exclusion criteria

Exclusion criteria: 1) Insulin dependent diabetes mellitus 2) Uncontrolable HT 3) Unstable angina, heart failure, or myocardial infarction 4) interstitial pneumonia or pulmonary fibrosis 5) positive HBs antigen 6) seropositive to HCV 7) seropositive to HIV 8) Severe infections 9)double cancer 10)Pregnant women 11) Sever mental disease 12) Patients inappropriate for transplantation with reasons other than above.

Design outcomes

Primary

Measure	Time frame
1)Therapy related mortality at 100 days after hematopoietic stem cell transplantation 2)Engraftment rate at 100 days after hematopoietic stem cell transplantation	—

Countries

Japan

Contacts

Public ContactTakakazu Kawase, M.D.

Aichi Cancer Center Department of Cell Therapy and Hematology

t-kawase@aidhi-cc.jp052-762-6111

Outcome results

None listed

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