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The effect and safety of TJ-14 adverse event associated autologous peripheral blood stem cell transplantation for multiple myeloma

The effect and safety of TJ-14 adverse event associated autologous peripheral blood stem cell transplantation for multiple myeloma - Hangesya-M

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034975
Enrollment
60
Registered
2019-01-01
Start date
2019-02-01
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

The patients dissolve TJ-14(2.5 g) in 50-100 ml of water and rinse their oral cavity with the solution three times daily for 10 seconds from chemotherapy to 3 days after engraftment. The patients do s

Sponsors

Hitachi general hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who undergo autologous stem cell transplantation ECOG-Performance Status (PS) is 0-2. Patients who are not allergic to Kanpo Patient who provided written consents for this study.

Exclusion criteria

Exclusion criteria: Uncontrolled active infection. Active gastrointestinal ulcer. Uncontrolled diabetes mellitus. Serious psychiatric illness. Patient who is judged to be medically unfit by physician.

Design outcomes

Primary

MeasureTime frame
The incidence of diarrhea grade 2 or higher between the TJ-14 group and control group in the period from transplantation to engraftment

Secondary

MeasureTime frame
The incidence of diarrhea in each grade The incidence of mucositis oral in each grade The period of appearance of diarrhea of Grade 2 or higher The period of appearance of mucositis oral of Grade 2 or higher Differences Alb between before chemotherapy and engraftment

Countries

Japan

Contacts

Public ContactTakuya Suyama

Hitachi general hospital hematology,oncology

sutaku2468@yahoo.co.jp0294231111

Outcome results

None listed

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