Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Lenalidomide

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle

40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle

dexamethasone

Toru Sasaki

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

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

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

Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.

CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).

CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.

Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.

PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.

The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.

Celgene

Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle

Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle

Lenalidomide Plus Dexamethasone

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Age, Continuous

≤ 75 Years Old

> 75 Years Old

Age, Customized

Sex: Female, Male

Stage I

Stage II

Stage III

The International Staging System (ISS) divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels.

Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L);

Stage II: Neither stage I or III, meaning that either:

* The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR
* The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5

Stage III: Serum beta-2 microglobulin is greater than 5.5.

Multiple Myeloma Stage before Study Entry

0 = Fully Active

1= Restrictive but Ambulatory

2 = Ambulatory but Unable to Work

3 = Limited Self-Care

4 = Completely Disabled

Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)

Eastern Cooperative Oncology Group (ECOG) Performance Status

The intent-to-treat (ITT) population consisted of all participants enrolled independent of whether they received study treatment or not.

Senior Manager, Clinical Trials Disclosure

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.

Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.

Overall Response Rate

Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug

Time to Response

Duration of Response

Progression Free Survival (PFS)

Overall Survival (OS)

Any adverse event

TEAE related to study drug

TEAE related to Lenalidomide

TEAE related to Dexamethasone

Grade 3-4 adverse event

Grade 3-4 adverse event related to any study drug

Grade 3-4 adverse event related to Lenalidomide

Grade 3-4 adverse event related to Dexamethasone

Serious TEAE

Serious TEAE related to any study drug

Serious TEAE related to Lenalidomide

Serious TEAE related to Dexamethasone

TEAE leading to discontinuation of either drug

TEAE leading to discontinuation of lenalidomide

TEAE leading to discontinuation of dexamethasone

Related TEAE discontinuation of either drug

Related TEAE discontinuation of lenalidomide

Related TEAE discontinuation of dexamethasone

Safety population includes all participants who received at least one dose of study drug.

Number of Participants With Adverse Events

Treatment Phase

Follow Up Phase

Spots Global Cancer Trial Database for A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial