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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

Phase 2
20 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

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

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 × 109/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 ×

- 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
HBV DNA test should be performed and if positive the subject will be excluded.

- Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by

- Ineligible for dexamethasone or dexamethasone is contraindicated.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

Number of Complete Response (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Masayuki Omote

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

October 2012

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • Lenalidomide
  • dexamethasone
  • newly diagnosed multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell