Analysis of efficacy and immunomodulatory activity of lenalidomide alone in relapse and refractory multiple myeloma

Analysis of efficacy and immunomodulatory activity of lenalidomide alone in relapse and refractory multiple myeloma - Immunomoduratory activity for MM treated with lenalidomide

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009927

Enrollment

Registered

2013-02-01

Start date

2013-02-01

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

plasma cell myeloma

Interventions

Treatment of lenalidomide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) relapse and refractory multiple myeloma without previously treated lenalidomide 2) Aged 20 to less than 81 years old 3) assessable M proteinemia or M proteinuira 4) ECOG PS 0-2 5) preserved mail organ function and implement the following criteria a) neutrophil count is more than 1x10e9/L b) platetel count is more than 5x10e10/L c) Total bilirubin is less than three times-fold in upper limit d) Serum AST and ALT are less than five times-fold in upper limit e) Serum creatinine is less than 2.5mg/dl f) ejection fraction in ultrasound cardiography is more than 50% g) PaO2 is more than 60mmHg or SpO2 is more than 93% 6) promising more than 3 months living 7) menopausal female and male and female are enable to prevent conception by the adequate methods, including the surgical conception 8) complete informed concent

Exclusion criteria

Exclusion criteria: 1) previously administered lenalidomide 2) hypersensitive reaction for lenalidomide, thalidomide and dexamethazone 3) non-secretory myeloma, solitary plasmacytoma, plasmacell leukemia and POEMS syndrome 4) CTCAE more than grade 3 neutropenia, thrombocytopenia 5) HBsAg is positive 6) HCV is positive, HIV is positive 7) uncontrollable liver dysfunction, renal insufficiency, cardiac dysfunction, respiratory dysfunction, diabetus mellitus, hypertension and infection 8) double cancer 9) psychoneurotic disorder, depression state or history 10) pregnant female, possible pregnancy or durling lactation 11) pulomonary fibrosis and interstitial pneumonitis interstitial shadow on chest CT, even if no sympton 12) physicians' decision

Design outcomes

Primary

Measure	Time frame
progression free survival time	—

Secondary

Measure	Time frame
safety, overall survival time, exploratory of immunomodulatory marker	—

Countries

Japan

Contacts

Public ContactNoriyasu Fukushima

Faculty of Medicine, Saga University Hematology, Respiratory Medicine and Oncology

fukushin@cc.saga-u.ac.jp0952-34-2366

Outcome results

None listed

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