Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan

Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan - Prospective observational study for MM in Japan (JSH-MM-15)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022099

Enrollment

1100

Registered

2016-05-01

Start date

2016-05-01

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

Newly diagnosed plasma cell neoplasms

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)diagnosed as having plasma cell neoplasms including MGUS, smoldering myeloma, symptomatic myeloma, non-secretary myeloma, solitary plasmacytoma of bone, extramedullary plasmacytoma based on International Myeloma Working Group(IMWG) criteria in 2014 2)newly diagnosed on January 1 in 2016 or later

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
3-year overall survival in patients with symptomatic myeloma who have received drug therapies in novel drug era	—

Secondary

Measure	Time frame
In patients with symptomatic myeloma who have received drug therapies: overall response rate(ORR), progression-free survival(PFS), time to next treatment(TNT), treatment-free interval(TFI), overall survival(OS) according to the difference of induction therapies, clinical stages, and cytogenetic risk groups in addition to exploring the incidence of second primary malignancies(SPM) after initial treatment In patients with plasma cell neoplasms except for symptomatic myeloma, systemic amyloidosis and POEMS syndrome, i.e., MGUS, smoldering myeloma, solitary plasmacytoma, multiple plasmacytoma and plasma cell leukemia: overall survival(OS), disease progression	—

Measure

Time frame

In patients with symptomatic myeloma who have received drug therapies: overall response rate(ORR), progression-free survival(PFS), time to next treatment(TNT), treatment-free interval(TFI), overall survival(OS) according to the difference of induction therapies, clinical stages, and cytogenetic risk groups in addition to exploring the incidence of second primary malignancies(SPM) after initial treatment In patients with plasma cell neoplasms except for symptomatic myeloma, systemic amyloidosis and POEMS syndrome, i.e., MGUS, smoldering myeloma, solitary plasmacytoma, multiple plasmacytoma and plasma cell leukemia: overall survival(OS), disease progression

—

Countries

Japan

Contacts

Public ContactHirohiko Shibayama

National Hospital Organization Osaka National Hospital Hematology

shibayama.hirohiko.ec@mail.hosp.go.jp06-6942-1331

Outcome results