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

Phase 2

• Conditions: plasma cell myeloma

• Registration Number: JPRN-UMIN000009927
• Lead Sponsor: Hematology, Respiratory Medicine and Oncology,Faculty of Medicine, Saga University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-01
• Study Completion: 2014-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression free survival time

Secondary Outcome Measures

Name	Time	Method
safety, overall survival time, exploratory of immunomodulatory marker