JPRN-jRCTs071180011
Active, not recruiting
Phase 2
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. - W-JHS MM01
Shibayama Hirohiko0 sites80 target enrollmentJanuary 4, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shibayama Hirohiko
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Primary enrollment inclusion criteria
- •1\) Patients are \>\= 20 years of age
- •2\) Patients who understand the informed consent and can sign the informed consent form by his/her free will.
- •3\) Patients who obey the protocol visit and other rules.
- •4\) Newly diagnosed multiple myeloma.
- •5\) Patients with following measurable M protein by protein electrophoresis analysis
- •6\) Patients who cannot carry out hematopoietic stem cells transplantation.
- •7\) ECOG PS 0,1 or 2
- •However,PS3 according to bone lesions are eligible.
- •8\) Female childbearing patients who meet the following requirements
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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