A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnose… (NCT01698801) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma
Japan26 participantsStarted 2012-10-01
Plain-language summary
To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.
Who can participate
Age range20 Years
SexALL
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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 …
What they're measuring
1
Overall Response Rate
Timeframe: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.