Prospective observational study for multiple myeloma (MM) in Japan

Prospective observational study II to assess the prognosis of patients with plasma cell neoplasms in Japan - JSH-MM-20

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046988

Enrollment

1200

Registered

2022-02-28

Start date

2022-02-28

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) Patients diagnosed with MGUS, smoldering myeloma, MM, non-secretory myeloma, solitary plasmacytoma of bone/soft tissue, or plasma cell leukemia according to IMWG classification. (2) To use the IMWG Diagnostic Criteria 2014 edition as diagnostic criteria [6]. (3) Newly diagnosed after January 1, 2022. (4) Patients registered in the epidemiological survey of the Japanese Society of Hematology "Blood Disease Registration" or the National Hospital Organization Network Joint Research "Disease Registration in Blood and Hematopoietic Diseases".

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
3-year survival rate of MM patients including non-secretory myeloma patients who received drug therapy in the new drug era	—

Secondary

Measure	Time frame
To clarify the following in patients with MM who received drug therapy: overall response rate (ORR); progression-free survival (PFS); time to next treatment (TNT); treatment-free interval (TFI); overall survival (OS); presence or absence of differences in efficacy endpoints by stage, according to differences in initial induction therapy and; presence or absence of differences in these efficacy endpoints by chromosomal risk category; understanding of the actual condition of secondary cancer development after the start of initial treatment; and understanding of the actual condition of arteriovenous thrombosis (including pulmonary embolism) after diagnosis. To clarify the following in plasma cell neoplasms other than MM, systemic AL amyloidosis and POEMS syndrome, which include MGUS, smoldering myeloma, solitary plasmacytoma, plasma cell leukemia: Overall survival; understanding of the actual situation including disease type transition.	—

Measure

Time frame

To clarify the following in patients with MM who received drug therapy: overall response rate (ORR); progression-free survival (PFS); time to next treatment (TNT); treatment-free interval (TFI); overall survival (OS); presence or absence of differences in efficacy endpoints by stage, according to differences in initial induction therapy and; presence or absence of differences in these efficacy endpoints by chromosomal risk category; understanding of the actual condition of secondary cancer development after the start of initial treatment; and understanding of the actual condition of arteriovenous thrombosis (including pulmonary embolism) after diagnosis. To clarify the following in plasma cell neoplasms other than MM, systemic AL amyloidosis and POEMS syndrome, which include MGUS, smoldering myeloma, solitary plasmacytoma, plasma cell leukemia: Overall survival; understanding of the actual situation including disease type transition.

—

Countries

Japan

Contacts

Public ContactTomoko Narita

Nagoya City University Institute of Medical and Pharmaceutical Sciences Hematology and Oncology

jsh-mm-20@hci-bc.com052-853-8738

Outcome results