A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

Celgene

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: dexamethasone

Drug: Lenalidomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01698801

CC-5013-MM-025

Details and patient eligibility

About

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.

Enrollment

26 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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
Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years
Subjects who are unable or unwilling to undergo antithrombotic therapy.
Peripheral neuropathy of ≥ grade 2 severity.
Uncontrolled systemic fungal, bacterial, or viral infection
Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease)
Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.
Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
Ineligible for dexamethasone or dexamethasone is contraindicated.