Newly diagnosed multiple myeloma
Conditions
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >- 20 years at the time of signing the ICD. 2) Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted. 3) Able to adhere to the study visit schedule and other protocol requirements. 4) Previously untreated, symptomatic multiple myeloma diagnostic criteria. 5) Have measurable disease by protein electrophoresis analyses. 6) At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation. 7) ECOG performance status of 0, 1, or 2.
Exclusion criteria
Exclusion criteria: 1) Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2) Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 3) Any condition that confounds the ability to interpret data from the study. 4) Previous treatment with anti-myeloma therapy. 5) Pregnant or lactating females. 6) Any of the following laboratory abnormalities: -Absolute neutrophil count (ANC) 3.0 X upper limit of normal 7) Renal failure requiring hemodialysis or peritoneal dialysis. 8) Prior history of malignancies, other than MM, unless the subject has been free of the disease for >= 5 years. 9) Subjects who are unable or unwilling to undergo antithrombotic therapy. 10) Peripheral neuropathy of >- grade 2 severity. 11) Uncontrolled systemic fungal, bacterial, or viral. 12) Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. Known human immunodeficiency virus (HIV) positivity. 13) Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis. 14) Ineligible for dexamethasone or dexamethasone is contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety -Time to response -Duration of response -Progression-free survival (PFS) -Overall survival (OS) -Safety | — |
Countries
Japan
Outcome results
None listed