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

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Oral 25mg daily on Days 1-21 every 28 days

Oral 25mg daily on Days 1-21 every 28 days.

CC-5013

Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.

Robert Knight, MD

The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

Open-Label, Single-Arm Study of the Safety and Efficacy of CC-5013 Monotherapy for Subjects With Multiple Myeloma: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010

An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;

Time to progression based on the myeloma response determination criteria developed by Bladé et al 1998 and is defined as the time from registration to the first documented progression. The progressive disease criteria included increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

Myeloma response determination criteria developed by Bladé et al 1998. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.

Duration of response based on the Myeloma response determination criteria developed by Bladé et al 1998 and defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on International Myeloma Working Group (IMWG) criteria.

Celgene

Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle

Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009

Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013

Lenalidomide 25mg (CC-5013)

Age, Continuous

> 65 years

≤ 65 years

Age, Customized

Sex: Female, Male

Asian/Pacific Islander

Black or African American

White

Hispanic

Race/Ethnicity, Customized

0 = Fully Active

1 = Restricted Activity

2 = Ambulatory; not able to work

3 = Limited Self Care

4 = Completely Disabled

Missing= Unspecified

Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient 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

Senior Manager, Clinical Trial Disclosure

Adverse Event (AE)

Adverse Event related to study drug

Adverse Event NCI CTC (Version2.0) Grade 3 or 4

Serious Adverse Event (SAE)

AE leading to discontinuation of study drug

AE leading to dose reduction/interruption

The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.

Number of Participants With Adverse Events (AE) During the Treatment Phase

Lenalidomide 25mg

Time to progression not analyzed per the sponsors decision.

Time to Progression

Myeloma Response Rate not analyzed per the sponsors decision.

Myeloma Response Rate

Duration of response not analyzed per the sponsors decision.

Duration of Response

≥ 1 Adverse Event (AE)

≥ 1 Serious Adverse Event (SAE)

≥ 1 AE leading to discontinuation of study drug

≥ 1 AE leading to dose reduction/interruption

Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.

Number of Participants With Adverse Events (AE) During the Extension Phase

Treatment Phase

Extension Phase

Spots Global Cancer Trial Database for A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial