Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Aggression

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

25 mg oral lenalidomide once daily on Days 1-21 every 28 days

lenalidomide

Lei Zhang, MD

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

* Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
* Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
* Partial Response(PR): \>50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
* Stable Disease(SD): Less than PR, but not progressive disease.
* Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.

Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.

For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.

Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

* Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.

Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

* Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.

Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

* Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
* Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
* Partial Response(PR): \>50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
* Stable Disease(SD): Less than PR, but not progressive disease.

Celgene

Treatment-emergent adverse events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0.

Age, Continuous

< 65 years

> = 65 years

Age, Customized

Gender

American Indian or Alaska Native

Asian/Pacific Islander

Black

Hispanic

White

Unspecified

Race/Ethnicity, Customized

Diffuse Large Cell Lymphoma

Follicular Lymphoma, Grade 3

Mantle Cell Lymphoma

Transformed Lymphoma

Non-Hodgkin's Lymphoma Diagnosis/Histopathology

Associate Director, Clinical Trial Disclosure

Complete Response (CR)

Complete Response Unconfirmed (CRu)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease

Participants Categorized by Best Response as Determined by Central Review

Duration of Response as Determined by Central Review

Time to Progression as Determined by Central Review

Progression-free Survival as Determined by Central Review

Tumor Control Rate or Proportion of Participants Who Experienced Stable Disease or Better (SD+PR+CRu+CR) was not analyzed. Overall Response Rate (PR+CRu+CR) is presented as the primary endpoint, and because it is a more widely accepted/used efficacy endpoint than tumor control rate, a decision was made not to analyze tumor control rate.

Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review

Overall Study

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

CC-5013 (lenalidomide) plus oral high-dose dexamethasone

Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.

CC-5013

Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

Robert Knight, MD

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.

Overall survival was calculated as the time from randomization to death from any cause.

The overall confirmed response that was maintained for ≥6 weeks. 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.

The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.

Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.

CC-5013/Dex

Placebo/Dex

Total

Age, Categorical

Sex: Female, Male

United States

Canada

Region of Enrollment

Analyses for efficacy had data cutoff dates of 07 Jun 2005 and a data cutoff date of 23 Jul 2008 for overall survival. Only safety data were collected for 6 subjects ongoing beyond the 23 Jul 2008 data cutoff date.

Robert Knight, M.D.

Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.

Time to Tumor Progression (TTP)

Overall Survival

Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.

Myeloma Response

Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)

Up to Unblinding (07 Jun 2005)

Extended Follow-up Cutoff (23 Jul 2008)

Final Follow-up

Doxorubicin

Liposomal doxorubicin

Vincristine

A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma

A Study of Doxil, Vincristine and Decadron (DVd) +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)

A Phase I Study of DVd +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)

Celgene Corporation

The planned doses for investigation are as follows: 5, 10, and 25 mg/day. Lenalidomide will be administered as a single daily dose for 4 weeks followed by a 2-week rest period. Dosing will be in the morning at approximately the same time each day, at least 1 hour before the morning meal. Patients will be assigned to dose level in the order of study entry. No dose adjustments or suspensions are allowed during the first cycle, except discontinuation for DLT

To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.

Identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment

Phase 1 Study OF CDC-501 in Patients With Solid Tumors

A Single-Center, Open-Label, Between-Patient, Dose-Escalation Phase 1 Study of CDC-501 In Patients With Solid Tumors

Symptoms and General Pathology

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .

Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Micronutrients

Hematinics

Vitamins

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

pemetrexed

Study will deteremine the MTD and evaluate the safety profile of oral lenalidomide on days 1-14 when combined with pemetrexed on day 1 of a 21 days cycle. Subjects will continue on study until documention of disease progression.

Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer

Prologue Research International

Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.

To determine the activity of lenalidomide in relapsed or refractory aggressive NHL.

Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)

A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) In Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.

CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.

Cru: Criteria for CR above but with 1 or more of the following:

* A residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)
* Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).

PR: 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.

Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.

SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).

PD was defined as

* ≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.
* Appearance of any new lesion during or at the end of therapy.

The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.

The duration of tumor control was calculated as the time from the first response assessment demonstrating at least stable disease to the first documentation of progressive disease or death due to NHL. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.

Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.

Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment.

The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.

The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:

* Grade 1 = Mild
* Grade 2 = Moderate
* Grade 3 = Severe
* Grade 4 = Life threatening
* Grade 5 = Death

A Serious AE is defined as 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 or constitutes an important medical event.

Missing

0 = fully active, no restrictions; 1 = restricted but ambulatory and capable of light work; 2 = ambulatory and capable of self care but unable to work.

Eastern Cooperative Oncology Group (ECOG) performance status

Stage I

Stage II

Stage III

Stage IV

I: The lymphoma is in only 1 lymph node area or 1 area of a single organ outside the lymph system.

II: The lymphoma is in 2 or more groups of lymph nodes on the same side of the diaphragm, or extends from a single group of node(s) into a nearby organ.

III: The lymphoma is found in lymph node areas on both sides of the diaphragm, or may also have spread into an area or organ next to the lymph nodes, the spleen, or both.

IV: The lymphoma has spread outside the lymph system into an organ that is not next to an involved node or has spread to bone marrow, liver, brain, spinal cord or the pleura.

Non-Hodgkin's Lymphoma (NHL) Stage

Follicular lymphoma grade 3

Diffuse large B-cell lymphoma

Mantle cell lymphoma

Transformed

NHL histology

NHL Duration

Low (0 to 1)

Low/Intermediate (2)

High/Intermediate (3)

High (4 to 5)

A clinical tool to aid in predicting the prognosis of patients with aggressive NHL. One point is assigned for each of the following risk factors:

* Age greater than 60 years
* Stage III or IV disease
* Elevated serum lactate dehydrogenase
* ECOG performance status of 2, 3, or 4 -\> 1 extranodal site

The sum of the points allotted correlates with the following risk groups:

Low risk (0-1 points): 5-year survival of 73% Low-intermediate risk (2 points): 5-year survival of 51% High-intermediate risk (3 points): 5-year survival of 43% High risk (4-5 points): 5-year survival of 26%

International Prognostic Index (IPI)

Intent to treat population includes all participants who received at least 1 dose of study drug.

Associate Director, Clinical Trials Disclosure

Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.

Percentage of Participants With Response

Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.

Percentage of Participants With Tumor Control

Intent to treat population with a response = CR, CRu or PR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma	NCT00413036	Lymphoma, Non-H...	lenalidomide	18 Years -	Celgene
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma	NCT00056160	Multiple Myelom...	CC-5013 Dexamethasone	18 Years -	Celgene
A Study of Doxil, Vincristine and Decadron (DVd) +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)	NCT00091624	Multiple Myelom...	CC-5013	18 Years -	Celgene Corporation
Phase 1 Study OF CDC-501 in Patients With Solid Tumors	NCT00046735	Neoplasms	Lenalidomide	18 Years -	Celgene
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma	NCT00413036	Lymphoma, Non-H...	lenalidomide	18 Years -	Celgene
Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome	NCT00044382	Myelodysplastic...	CC-5013	18 Years -	Celgene
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer	NCT00179699	Non-Small Cell ...	CC-5013 pemetrexed	18 Years -	Celgene
Phase 1 Study OF CDC-501 in Patients With Solid Tumors	NCT00046735	Neoplasms	Lenalidomide	18 Years -	Celgene
Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)	NCT00179660	Non-Hodgkins Ly...	Lenalidomide	18 Years -	Celgene
Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma	NCT00179673	Non-Hodgkins Ly...	Lenalidomide	18 Years -	Celgene
Study to Compare the Efficacy and Safety of Two CC-5013 Dose Regimens in Subjects With Metastatic Malignant Melanoma	NCT00055562	Melanoma Neoplasm Metast...	CC 5013	18 Years -	Celgene
Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma	NCT00065351	Multiple Myelom...	CC-5013	18 Years -	Celgene
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer	NCT00179699	Non-Small Cell ...	CC-5013 pemetrexed	18 Years -	Celgene

Spots Global Cancer Trial Database for cc5013

Every month we try and update this database with for cc5013 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cc5013

Every month we try and update this database with for cc5013 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cc5013 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.