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Trial record 58 of 494 for:    LENALIDOMIDE AND every 28 days

A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL). (RENEW)

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ClinicalTrials.gov Identifier: NCT01021423
Recruitment Status : Terminated (Terminated by sponsor due to new unpublished data that rendered the current design of the study no longer clinically relevant. There were no safety concerns.)
First Posted : November 30, 2009
Results First Posted : December 2, 2011
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
Interventions Drug: Lenalidomide
Other: Placebo
Enrollment 9
Recruitment Details  
Pre-assignment Details Randomization was stratified according to 1) the type of first-line induction chemotherapy (anthracycline-based, fludarabine-based, or rituximab-bendamustine combination therapy) and 2) the response to first-line induction chemotherapy (complete response or partial response).
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal. Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Period Title: Overall Study
Started 4 [1] 5 [2]
Completed 0 0
Not Completed 4 5
Reason Not Completed
Study terminated             4             5
[1]
One participant discontinued treatment (continued in the study) due to an AE
[2]
One participant discontinued treatment (continued in the study) due to disease progression
Arm/Group Title Lenalidomide Placebo Total
Hide Arm/Group Description Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal. Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal. Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
77.8  (4.65) 73.0  (6.89) 75.1  (6.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
1
  25.0%
2
  40.0%
3
  33.3%
Male
3
  75.0%
3
  60.0%
6
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
5
 100.0%
9
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Status = 0 4 3 7
Status = 1 0 2 2
[1]
Measure Description: Category 0 = Fully active, able to carry on all pre-diseases performance without restriction; Category 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g. light housework, office work).
Response of Mantle Cell Lymphoma (MCL) to chemotherapy at enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Complete response 3 1 4
Partial response 1 4 5
[1]
Measure Description: Participants' response to first-line chemotherapy. Response evaluation was as defined by 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007). Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description

PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir.

Study terminated prematurely. Analysis not conducted.

Time Frame up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Analysis not performed.
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival
Hide Description

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

Study terminated prematurely. Analysis not conducted.

Time Frame up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Analysis not performed.
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description

Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.

The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE.

Time Frame up to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants who received at least one dose of study drug
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Overall Number of Participants Analyzed 4 5
Measure Type: Number
Unit of Measure: participants
At least one TEAE 4 4
At least one TEAE related to study drug 3 2
At least one NCI CTC grade 3-4 TEAE 1 1
At least one NCI CTC grade 3-4 related to drug 1 1
At least one serious TEAE 1 0
At least one serious TEAE related to drug 1 0
TEAE leading to discontinuation of drug 1 0
Related TEAE leading to discontinuation of drug 1 0
TEAE leading to dose reduction or interruption 1 1
Related TEAE - dose reduction or interruption 1 1
4.Secondary Outcome
Title Time to Progression
Hide Description

Time to progression was defined as the time from the date of randomization until the first date of documented disease progression.

Study terminated prematurely. Analysis not conducted.

Time Frame up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Analysis not conducted.
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Analysis not conducted.
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Participants With a Tumor Response
Hide Description

Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).

Study terminated prematurely. Analysis not conducted.

Time Frame up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Analysis not conducted.
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description:
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Treatment emergent adverse events occurred during the treatment period, plus 30 days. Due to early termination, the longest experience was 245 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide Placebo
Hide Arm/Group Description Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal. Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
All-Cause Mortality
Lenalidomide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma  1  1/4 (25.00%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   4/5 (80.00%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/4 (25.00%)  1/5 (20.00%) 
Neutropenia  1  1/4 (25.00%)  0/5 (0.00%) 
Eye disorders     
Conjunctivitis  1  1/4 (25.00%)  0/5 (0.00%) 
Gastrointestinal disorders     
Constipation  1  1/4 (25.00%)  1/5 (20.00%) 
Abdominal pain upper  1  1/4 (25.00%)  0/5 (0.00%) 
Diarrhoea  1  1/4 (25.00%)  0/5 (0.00%) 
Dry mouth  1  1/4 (25.00%)  0/5 (0.00%) 
Flatulence  1  1/4 (25.00%)  0/5 (0.00%) 
Stomatitis  1  1/4 (25.00%)  0/5 (0.00%) 
General disorders     
Asthemia  1  0/4 (0.00%)  1/5 (20.00%) 
Chills  1  1/4 (25.00%)  0/5 (0.00%) 
Oedema peripheral  1  1/4 (25.00%)  0/5 (0.00%) 
Infections and infestations     
Herpes zoster  1  1/4 (25.00%)  0/5 (0.00%) 
Herpes zoster ophthalmic  1  1/4 (25.00%)  0/5 (0.00%) 
Nasopharyngitis  1  0/4 (0.00%)  1/5 (20.00%) 
Rhinitis  1  0/4 (0.00%)  1/5 (20.00%) 
Viral rash  1  1/4 (25.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  1/4 (25.00%)  0/5 (0.00%) 
Neck pain  1  1/4 (25.00%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/4 (25.00%)  0/5 (0.00%) 
Malignant melanoma  1  1/4 (25.00%)  0/5 (0.00%) 
Nervous system disorders     
Dysgeusia  1  1/4 (25.00%)  0/5 (0.00%) 
Headache  1  0/4 (0.00%)  1/5 (20.00%) 
Peripheral sensory neuropathy  1  1/4 (25.00%)  0/5 (0.00%) 
Psychiatric disorders     
Libido decrease  1  1/4 (25.00%)  0/5 (0.00%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  1/4 (25.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
Eczema  1  1/4 (25.00%)  0/5 (0.00%) 
Pruritis  1  0/4 (0.00%)  1/5 (20.00%) 
Rash  1  1/4 (25.00%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Study terminated early. Most analyses were not performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
  • Multicenter publication must include input from investigators and Celgene, agreement to be established before publication.
  • Multicenter publication has priority over subset (single center) publication, for duration of 1 year after study completion.
  • Individual investigators have publication right after multicenter publication is complete or 1 year after study completion, whichever is first. Celgene has the right to comment and right to ask delay of publication for up to 90 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT01021423     History of Changes
Other Study ID Numbers: CC-5013-MCL-003
First Submitted: November 25, 2009
First Posted: November 30, 2009
Results First Submitted: October 31, 2011
Results First Posted: December 2, 2011
Last Update Posted: February 14, 2012