A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Celgene
- Enrollment
- 26
- Locations
- 24
- Primary Endpoint
- Overall Response Rate
Overview
Brief Summary
To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 20 years at the time of signing the informed consent document
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
- •Able to adhere to the study visit schedule and other protocol requirements
- •Previously untreated, symptomatic multiple myeloma
- •Have measurable disease by protein electrophoresis analyses
- •At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan
Exclusion Criteria
- •Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- •Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •Any condition that confounds the ability to interpret data from the study
- •Previous treatment with anti-myeloma therapy
- •Pregnant or lactating females
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) \< 1,000/microL (1.0 × 10\^9/L )
- •Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) \< 50,000 cells/microL (50 × 10\^9/L)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3.0 × upper limit of normal
- •Renal failure requiring hemodialysis or peritoneal dialysis
Arms & Interventions
Lenalidomide plus dexamethasone
Lenalidomide plus low-dose dexamethasone
Intervention: Lenalidomide (Drug)
Lenalidomide plus dexamethasone
Lenalidomide plus low-dose dexamethasone
Intervention: dexamethasone (Drug)
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder. CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Secondary Outcomes
- Duration of Response(From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.)
- Overall Survival (OS)(From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months)
- Progression Free Survival (PFS)(From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.)
- Number of Participants With Adverse Events(From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks)
- Time to Response(From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.)