Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis

Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis - Nonmyeloablative allogeneic stem cell transplantation for multiple myeloma with poor prognosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001962

Enrollment

Registered

2009-05-13

Start date

2009-07-01

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

Nonmyeloablative allogeneic stem cell transplantation as a consolidation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All of the following are required. (1)Multiple myeloma patient with evaluable lesion(s) (2)Age between 20 and 65 (3)PS 0-2 (4)A patient should receive a single high-dose chemotherapy and autologous peripheral blood stem cell transplantation within 60-270 days and achieve partial or complete response. (5)More than 1x106/kg cryopreserved autologous CD34 positive cells for backup (6)A patient should have at least one unfavorable factor at initial treatment. Unfavorable factors include ISS stage 3, del13/complex CA/hypodiploid in G-band, t(4;14)/t(14;16)/del17p in FISH. (7)Suitable donor is available: (a) HLA genotypically identical related donor or (b) HLA-ABC genotypically identical unrelated donor with HLA-DRB1 genotypically mismatched at 0-1 locus. (8)(a) PaO2>70mmHg or SatO2>90% and (b) serum creatinine <1.5xWNL (9)HCT-CI 0-2 (10)Written informed consent to participate in the trial.

Exclusion criteria

Exclusion criteria: (1)Positive for HIV antibody, HBs antigen and/or HBe antigen (2)Pregnant or during breast feeding (3)Other active cancer (4)Active psychiatric disease (5)Active infection (6)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen. (7)Cases that physicians judged as inappropriate

Design outcomes

Secondary

Measure	Time frame
Engraftment rates, regimen-related toxicities, chimerism on peripheral blood, term to hematopoietic recovery, response rates, overall survival rates at 2 years, progression free survival at 2 years, nonrelapse mortality rates at 2 years, incidence of acute GVHD, and incidence of chronic GVHD	—

Primary

Measure	Time frame
Cumulative incidence of nonrelapse mortality at 6 months	—

Countries

Japan

Contacts

Public ContactYoshihiro Inamoto

Nagoya University Graduate School of Medicine Department of Hematology and Oncology

yinamoto@med.nagoya-u.ac.jp052-744-2145

Outcome results

None listed

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