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Trial record 14 of 495 for:    LENALIDOMIDE AND every 28 days

Lenalidomide Maintenance Therapy for Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01675141
Recruitment Status : Terminated (Original investigator left the NIH and the primary outcome was not reached)
First Posted : August 29, 2012
Results First Posted : May 12, 2017
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Dickran Kazandjian, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: Lenalidomide
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Period Title: Overall Study
Started 11
Completed 0
Not Completed 11
Reason Not Completed
Lenalidomide outside NIH             3
Withdrawal by Subject             3
Physician Decision             4
No treatment, per protocol             1
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  81.8%
>=65 years
2
  18.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
57.05  (8.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
2
  18.2%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  18.2%
White
5
  45.5%
More than one race
1
   9.1%
Unknown or Not Reported
1
   9.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Not Hispanic
9
  81.8%
Mexican, Cuban, Puerto Rican, Central/So. American
2
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts
Hide Description Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.
Time Frame participants were followed for the duration of their treatment, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description:

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Hide Description Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame 37 months and 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description:

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
11
 100.0%
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.
Time Frame participants were followed for the duration of their treatment, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description:

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(0.9 to NA)
[1]
The median and upper limit of 95% CI is NR (not reached). The median and upper limit were not reached because there was not enough follow up time to reach a median or upper limit.
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS is defined as the time from study entry until progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.
Time Frame participants were followed for the duration of their treatment, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description:

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 11
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(16.2 to NA)
[1]
The median and upper limit of 95% CI is NR (not reached). The median and upper limit were not reached because there was not enough follow up time to reach a median or upper limit.
5.Secondary Outcome
Title Natural Killer (NK) Cell Function and Activity
Hide Description Percent of target cell lysis by NK cells
Time Frame participants were followed for the duration of their treatment, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description:

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Changes in B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy
Hide Description Percent change in total number of B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy
Time Frame participants were followed for the duration of their treatment, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description:

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Expression of Cereblon (CRBN) and How it Relates to Natural Killer (NK) Cell Number and Activity
Hide Description Relative fold change in CRBN and correlation (R2) to NK cell number and activity.
Time Frame participants were followed for the duration of their treatment, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description:

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 37 months and 12 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide Maintenance Therapy for Multiple Myeloma
Hide Arm/Group Description

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

All-Cause Mortality
Lenalidomide Maintenance Therapy for Multiple Myeloma
Affected / at Risk (%)
Total   0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Maintenance Therapy for Multiple Myeloma
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide Maintenance Therapy for Multiple Myeloma
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  5/11 (45.45%)  11
Eye disorders   
Watering eyes  1  1/11 (9.09%)  1
Gastrointestinal disorders   
Constipation  1  2/11 (18.18%)  2
Diarrhea  1  2/11 (18.18%)  2
Hemorrhoids  1  1/11 (9.09%)  1
Vomiting  1  1/11 (9.09%)  1
General disorders   
Edema face  1  1/11 (9.09%)  2
Fatigue  1  2/11 (18.18%)  3
Fever  1  1/11 (9.09%)  1
Flu like symptoms  1  1/11 (9.09%)  1
Pain  1  1/11 (9.09%)  3
Infections and infestations   
Infections and infestations - Other, dental abscess  1  1/11 (9.09%)  1
Lung infection  1  1/11 (9.09%)  1
Sinusitis  1  1/11 (9.09%)  1
Skin infection  1  1/11 (9.09%)  1
Upper respiratory infection  1  2/11 (18.18%)  2
Injury, poisoning and procedural complications   
Fall  1  1/11 (9.09%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  2/11 (18.18%)  2
Alanine aminotransferase increased  1  4/11 (36.36%)  6
Alkaline phosphatase increased  1  4/11 (36.36%)  6
Aspartate aminotransferase increased  1  4/11 (36.36%)  9
Blood bilirubin increased  1  2/11 (18.18%)  3
CPK increased  1  3/11 (27.27%)  6
Creatinine increased  1  5/11 (45.45%)  11
Lymphocyte count decreased  1  8/11 (72.73%)  18
Neutrophil count decreased  1  8/11 (72.73%)  25
Platelet count decreased  1  4/11 (36.36%)  9
White blood cell decreased  1  10/11 (90.91%)  29
Metabolism and nutrition disorders   
Hypermagnesemia  1  1/11 (9.09%)  1
Hypernatremia  1  2/11 (18.18%)  3
Hyperuricemia  1  1/11 (9.09%)  1
Hypoalbuminemia  1  3/11 (27.27%)  4
Hypocalcemia  1  2/11 (18.18%)  2
Hypokalemia  1  2/11 (18.18%)  2
Hypomagnesemia  1  1/11 (9.09%)  1
Hypophosphatemia  1  4/11 (36.36%)  6
Musculoskeletal and connective tissue disorders   
Back pain  1  2/11 (18.18%)  2
Chest wall pain  1  1/11 (9.09%)  1
Myalgia  1  5/11 (45.45%)  5
Pain in extremity  1  1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, primary prostate cancer  1  1/11 (9.09%)  1
Nervous system disorders   
Dizziness  1  1/11 (9.09%)  1
Dysgeusia  1  1/11 (9.09%)  1
Paresthesia  1  1/11 (9.09%)  1
Peripheral sensory neuropathy  1  2/11 (18.18%)  2
Somnolence  1  1/11 (9.09%)  1
Psychiatric disorders   
Insomnia  1  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Postnasal drip  1  1/11 (9.09%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  4/11 (36.36%)  4
Pruritus  1  2/11 (18.18%)  2
Rash maculo-papular  1  2/11 (18.18%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dickran Kazandijian
Organization: National Cancer Institute
Phone: 301-451-2677
EMail: kazandijiandg@nih.gov
Layout table for additonal information
Responsible Party: Dickran Kazandjian, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01675141     History of Changes
Other Study ID Numbers: 120192
12-C-0192
First Submitted: August 25, 2012
First Posted: August 29, 2012
Results First Submitted: April 4, 2017
Results First Posted: May 12, 2017
Last Update Posted: February 2, 2018