A Safety Confirmation Study On Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Celgene
- Enrollment
- 25
- Locations
- 8
- Primary Endpoint
- Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Overview
Brief Summary
To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients with previously treated 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
- •Must understand and voluntarily sign the informed consent form
- •Age ≥ 20 years at the time of signing the informed consent form
- •Subjects with previously treated multiple myeloma defined as follows:
- •Subjects must have received at least 1 prior anti-myeloma drug treatment regimen; and
- •Considered to have progression of disease (PD) that occurred either during or following the completion of the last anti-myeloma treatment regimen utilized prior to enrollment into this study
- •Measurable levels of M-protein in serum (greater than or equal to 0.5 g/dL \[5g/L\]) or urine (greater than or equal to 0.2 g excreted in a 24-hour collection sample)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- •Must be able to adhere to the study visit schedule and other protocol requirements
- •Females of childbearing potential (FCBP) must agree to use one or more of the following forms of contraception or abstain from heterosexual contact completely and have the male partners use a condom on the occasion of heterosexual contact in the following periods below:
- •For at least 28 days before starting study drug (in particular, the subject must abstain from heterosexual contact for 2 weeks prior to prescribing lenalidomide).
Exclusion Criteria
- •Pregnant or lactating females
- •Subjects with a history of acute myocardial infarction within the past 6 months before starting the study drugs
- •Subjects with any history or concurrent conditions of deep vein thrombosis or pulmonary embolus within the past 3 years before starting study drugs
- •Subjects with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
- •Subjects with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
- •Subjects with posterior subcapsular cataracts
- •Subjects with peripheral neuropathy of ≥Grade 2
- •Subjects with any history or concurrent conditions which the Principal Investigator / subinvestigators consider inappropriate for participation in this study, and subjects with a serious disease or a mental disease, which is considered to become more risky if the subjects participate in this study.
- •Subjects with a history of desquamative (blistering) rash while taking thalidomide
- •Subjects with a history of using lenalidomide
Arms & Interventions
Lenalidomide and Dexamethasone
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Intervention: Lenalidomide (Drug)
Lenalidomide and Dexamethasone
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Time Frame: Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)
Secondary Outcomes
- Kaplan-Meier Estimates of Duration of Response (DoR)(From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks)
- Myeloma Response Rate(From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks)