Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00555100

Enrollment

Registered

2007-11-07

Start date

2007-07-01

Completion date

2010-12-01

Last updated

2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy Maximum Tolerated Dose (MTD) Determination Cohort; and 2) Combination Treatment Cohort.

Interventions

DRUGlenalidomide

10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.

DRUGdexamethasone

40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects with previously treated multiple myeloma * Measurable levels of m-protein in serum \>= 0.5 g/dL \[5g/L\]) or urine (\>= 0.2 g excreted in a 24-hour collection sample) * ECOG performance status of 0 - 2 * Willing to follow pregnancy precautions

Exclusion criteria

* Patients with acute an myocardial infarction (MI) within the past 6 months, or patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 3 years * Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases * Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma * Patients with posterior subcapsular cataracts * Patients with mental illness * Patients with past histories or complications which make the Investigator or other staff member deem them inappropriate for this study * Pregnant or lactating females * Grade 2 or worse neuropathy * Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) \< 1,000cells/mL Platelet count \< 75,000/mL Serum creatinine \> 2.5 mg/dL Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN) * Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for \>= 3 years. - Patients who received radiation therapy within 14 days of the start of study drug * Patients with scars from a recent viscus operation * Patients with history of a desquamating (blistering) rash while taking thalidomide * Patients with prior use of lenalidomide * Patients with known HIV positivity. * Patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of MM within 28 days of the start of lenalidomide therapy. * Patients with known history of hypersensitivity to dexamethasone.

Design outcomes

Primary

Measure	Time frame
DLT	first cycle (28 days)

Secondary

Measure	Time frame
Efficacy (M-protein)	24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026