Evaluation of efficacy and safety of a response adapted therapy adding bortezomib in newly diagnosed, transplant ineligible multiple myeloma patients with insufficient efficacy by lenalidomide - dexamethasone (Rd) therapy.
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000026498
- Lead Sponsor
- Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
Primary enrollment exclusion criteria 1) Patients with severe disorder, laboratory test abnormality, mental disease. 2) Patient having a severe disease thought to be exposed to unacceptable risks if he/she participates in the study. 3) Patients who are in a state with the possibility to have an influence on the interpretation of the study data. 4) Patients with treatment history of myeloma. 5) Female patients with pregnancy or nursing. 6) Patients with following laboratory test abnormality. Neutrophil < 1000/mm3 Platelet before transfusion < 50,000/mm3 (7 days passed after platelet transfusion) AST or ALT > 3 X ULN 7) Patients with renal failure needed for hemodialysis or peritoneal dialysis. 8) Patients with anamnesis of malignant tumor other than MM 9) Patients who are or will not received antithrombotic therapy. 10) Patients with grade 2 or more peripheral neuropathy. 11) Patients with incontrollable systemic fungal/bacterial/viral infection 12) Patients with primary amyloidosis (AL) (immunoglobulin light chain) or myeloma with amyloidosis. 13) Patients not receiving dexamethasone or with contraindication of dexamethasone. 14) Patients not receiving bortezomib or with contraindication of bortezomib. Secondary enrollment exclusion criteria 1) Patients met exclusion criteria after primary enrollment. 2) Patient who are confirmed for human immunodeficiency virus (HIV)-positive or treated. 3) Patients with hepatitis B virus (HBs antigen) positive or hepatitis C virus (HCV) antibody positive (if HBc antibody or HBs antibody is positive even if HBs antigen is negative, hepatitis B virus (HBV) DNA test is carried out. If HBV DNA is detected, The patients are excluded) 4) Any other patients who are regarded as unsuitable for this study by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method