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Safety and efficacy of tandem Autologous-Allogeneic peripheral blood stem cell transplantation in patients with multiple myeloma relapsing after a first high dose therapy

Safety and efficacy of tandem Autologous-Allogeneic peripheral blood stem cell transplantation in patients with multiple myeloma relapsing after a first high dose therapy - Allo-PBSCT for relapsed multiple myeloma patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040635
Enrollment
5
Registered
2020-06-25
Start date
2020-06-25
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

1.re-auto PBSCT phase High-dose melphalan and bortezomib followed by auto-PBSCT Between 40-120 days after auto-PBSCT,patients proceeded to RIC allo-PBSCT 2.Allogeneic PBSCT phase fludarabine 30mg/

Sponsors

Department of hematology, Tokyo-kita Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patient who relapse <18 months after first or tandem auto-PBSCT. 2.>=PR after salvage treatment. 3.ECOG PS is 0-2. 4.Patient for whom a HLA-matched sibling donor was identified. 5.Liver function:serum T-Bil <= 2 times the upper limit of normal. 6.Renal function:Ccr >= 40ml/min. 7.Heart function:EF >= 40% 8.The other major organ functions are normal. 9.Patient who provided written consents for this study.

Exclusion criteria

Exclusion criteria: 1.Uncontrolled active infection. 2.Cardiac amyloidosis. 3.Patient who is judged to be medically unfit by his/her physician.

Design outcomes

Primary

MeasureTime frame
The Non-relapse mortality(NRM) at 100 days after allogeneic peripheral blood stem cell transplantation

Secondary

MeasureTime frame
Adverse event Engraftment Response rate NRM at 1-,2-,and 3-years Acute and chronic GVHD Relapse rate Progression free survival Overall survival

Countries

Japan

Contacts

Public ContactDaisuke Kudo

Tokyo-kita Medical Center Department of hematology

daisukekud@jadecom.jp03-5963-3311

Outcome results

None listed

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