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Trial record 59 of 791 for:    LENALIDOMIDE AND cells

Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00553644
Recruitment Status : Completed
First Posted : November 5, 2007
Results First Posted : February 20, 2014
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Mantle Cell Lymphoma
Interventions Drug: Bortezomib
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Enrollment 53
Recruitment Details Between November 2007 and July 2011, 54 participants were recruited to this study.
Pre-assignment Details One participant was deemed ineligible and removed for all analyses; therefore, 53 participants were analyzed.
Arm/Group Title Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Hide Arm/Group Description

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO

Period Title: Overall Study
Started 53
Completed 25
Not Completed 28
Reason Not Completed
Adverse Event             17
Withdrawal by Subject             4
Physician Decision             1
Alternative therapy             6
Arm/Group Title Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Hide Arm/Group Description

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO

Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 53 participants
67
(39 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
9
  17.0%
Male
44
  83.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants
53
1.Primary Outcome
Title Number of Participants With an Overall Response Defined as Complete Response and Partial Response
Hide Description

Response is assessed by investigator according to International Working Group (IWG) criteria.

A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.

Time Frame Duration of treatment (assessed up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO

Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: participants
21
2.Secondary Outcome
Title Incidence of Adverse Events
Hide Description Number of participants who experienced a maximum grade 3, 4 or 5 adverse event. The grading scales found in the revised NCI CTCAE version 4.0 was utilized for adverse event reporting
Time Frame Duration of Treatment (up to 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO

Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: participants
Grade 2 4
Grade 3 29
Grade 4 17
Grade 5 1
3.Secondary Outcome
Title Time to Progression
Hide Description Time to progression (TTP) is defined as the time from study entry until progression or death due to any cause. The median TTP with 95% CI was estimated using the Kaplan-Meier method.
Time Frame Assessed up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO

Overall Number of Participants Analyzed 53
Median (95% Confidence Interval)
Unit of Measure: years
0.58
(0.29 to 1.15)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is defined as the time from study entry until death. The median OS with 95% CI was estimated using the Kaplan-Meier method..
Time Frame Assessed up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Hide Arm/Group Description:

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO

Overall Number of Participants Analyzed 53
Median (95% Confidence Interval)
Unit of Measure: years
2.17
(1.15 to 4.58)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Hide Arm/Group Description lenalidomide: Given PO
All-Cause Mortality
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   24/53 (45.28%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/53 (1.89%)  1
Hemoglobin decreased  1  19/53 (35.85%)  23
Cardiac disorders   
Mobitz type I  1  1/53 (1.89%)  1
Eye disorders   
Diplopia  1  1/53 (1.89%)  1
Eye disorder  1  1/53 (1.89%)  1
Gastrointestinal disorders   
Abdominal pain  1  4/53 (7.55%)  4
Constipation  1  3/53 (5.66%)  3
Diarrhea  1  8/53 (15.09%)  8
Dry mouth  1  1/53 (1.89%)  1
Dysphagia  1  1/53 (1.89%)  1
Ear, nose and throat examination abnormal  1  2/53 (3.77%)  2
Ileus  1  1/53 (1.89%)  1
Nausea  1  9/53 (16.98%)  9
Oral pain  1  1/53 (1.89%)  1
Vomiting  1  6/53 (11.32%)  6
General disorders   
Disease progression  1  3/53 (5.66%)  3
Edema limbs  1  4/53 (7.55%)  4
Facial pain  1  1/53 (1.89%)  1
Fatigue  1  15/53 (28.30%)  18
Fever  1  6/53 (11.32%)  7
Infections and infestations   
Abdominal infection  1  1/53 (1.89%)  1
Conjunctivitis infective  1  1/53 (1.89%)  1
Infection  1  2/53 (3.77%)  2
Otitis externa  1  1/53 (1.89%)  1
Pneumonia  1  2/53 (3.77%)  2
Sepsis  1  2/53 (3.77%)  2
Upper respiratory infection  1  1/53 (1.89%)  1
Injury, poisoning and procedural complications   
Intraoperative complications  1  1/53 (1.89%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  1/53 (1.89%)  1
Alanine aminotransferase increased  1  5/53 (9.43%)  6
Alkaline phosphatase increased  1  5/53 (9.43%)  5
Aspartate aminotransferase increased  1  5/53 (9.43%)  5
Blood bilirubin increased  1  3/53 (5.66%)  4
Creatinine increased  1  7/53 (13.21%)  8
INR increased  1  1/53 (1.89%)  2
Leukocyte count decreased  1  11/53 (20.75%)  11
Lymphocyte count decreased  1  6/53 (11.32%)  8
Neutrophil count decreased  1  11/53 (20.75%)  12
Platelet count decreased  1  20/53 (37.74%)  24
Weight loss  1  2/53 (3.77%)  2
Metabolism and nutrition disorders   
Anorexia  1  6/53 (11.32%)  6
Blood glucose increased  1  5/53 (9.43%)  6
Blood uric acid increased  1  2/53 (3.77%)  3
Dehydration  1  3/53 (5.66%)  3
Serum albumin decreased  1  8/53 (15.09%)  8
Serum calcium decreased  1  11/53 (20.75%)  12
Serum calcium increased  1  1/53 (1.89%)  1
Serum glucose decreased  1  1/53 (1.89%)  1
Serum magnesium decreased  1  2/53 (3.77%)  2
Serum phosphate decreased  1  3/53 (5.66%)  3
Serum potassium decreased  1  3/53 (5.66%)  3
Serum potassium increased  1  2/53 (3.77%)  2
Serum sodium decreased  1  4/53 (7.55%)  4
Serum sodium increased  1  2/53 (3.77%)  2
Musculoskeletal and connective tissue disorders   
Back pain  1  3/53 (5.66%)  4
Muscle weakness  1  2/53 (3.77%)  2
Nervous system disorders   
Dizziness  1  4/53 (7.55%)  4
Dysgeusia  1  1/53 (1.89%)  2
Facial muscle weakness  1  1/53 (1.89%)  1
Headache  1  1/53 (1.89%)  1
Ischemia cerebrovascular  1  1/53 (1.89%)  1
Neuralgia  1  1/53 (1.89%)  1
Neurological disorder NOS  1  2/53 (3.77%)  2
Oculomotor nerve disorder  1  1/53 (1.89%)  1
Peripheral motor neuropathy  1  3/53 (5.66%)  3
Peripheral sensory neuropathy  1  6/53 (11.32%)  8
Speech disorder  1  1/53 (1.89%)  1
Syncope  1  3/53 (5.66%)  3
Trigeminal nerve disorder  1  1/53 (1.89%)  1
Psychiatric disorders   
Anxiety  1  1/53 (1.89%)  1
Confusion  1  1/53 (1.89%)  1
Insomnia  1  2/53 (3.77%)  2
Renal and urinary disorders   
Renal failure  1  1/53 (1.89%)  1
Urogenital disorder  1  1/53 (1.89%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  2/53 (3.77%)  2
Cough  1  3/53 (5.66%)  3
Dyspnea  1  8/53 (15.09%)  9
Hypoxia  1  2/53 (3.77%)  2
Pleural effusion  1  2/53 (3.77%)  2
Pneumonitis  1  3/53 (5.66%)  3
Skin and subcutaneous tissue disorders   
Dry skin  1  3/53 (5.66%)  3
Hand-and-foot syndrome  1  1/53 (1.89%)  1
Petechiae  1  1/53 (1.89%)  1
Pruritus  1  2/53 (3.77%)  2
Rash desquamating  1  1/53 (1.89%)  1
Skin disorder  1  1/53 (1.89%)  1
Sweating  1  1/53 (1.89%)  1
Vascular disorders   
Hemorrhage  1  1/53 (1.89%)  1
Hypertension  1  1/53 (1.89%)  1
Hypotension  1  5/53 (9.43%)  6
Thrombosis  1  2/53 (3.77%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
Affected / at Risk (%) # Events
Total   48/53 (90.57%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  38/53 (71.70%)  200
Lymph node pain  1  2/53 (3.77%)  4
Cardiac disorders   
Cardiac pain  1  1/53 (1.89%)  1
Left ventricular failure  1  1/53 (1.89%)  1
Palpitations  1  1/53 (1.89%)  1
Sinus bradycardia  1  2/53 (3.77%)  5
Sinus tachycardia  1  1/53 (1.89%)  1
Ventricular trigeminy  1  1/53 (1.89%)  1
Ear and labyrinth disorders   
Hearing impaired  1  1/53 (1.89%)  1
Endocrine disorders   
Hypothyroidism  1  1/53 (1.89%)  1
Eye disorders   
Diplopia  1  1/53 (1.89%)  1
Dry eye syndrome  1  2/53 (3.77%)  12
Eye disorder  1  2/53 (3.77%)  2
Flashing vision  1  1/53 (1.89%)  3
Vision blurred  1  5/53 (9.43%)  11
Gastrointestinal disorders   
Abdominal distension  1  1/53 (1.89%)  2
Abdominal pain  1  8/53 (15.09%)  11
Ascites  1  1/53 (1.89%)  2
Colonic hemorrhage  1  1/53 (1.89%)  2
Constipation  1  20/53 (37.74%)  76
Diarrhea  1  22/53 (41.51%)  65
Dry mouth  1  2/53 (3.77%)  3
Dyspepsia  1  3/53 (5.66%)  4
Dysphagia  1  1/53 (1.89%)  3
Ear, nose and throat examination abnormal  1  2/53 (3.77%)  2
Esophagitis  1  1/53 (1.89%)  1
Flatulence  1  2/53 (3.77%)  3
Gastrointestinal disorder  1  3/53 (5.66%)  3
Nausea  1  18/53 (33.96%)  44
Oral pain  1  1/53 (1.89%)  1
Vomiting  1  10/53 (18.87%)  15
General disorders   
Chills  1  4/53 (7.55%)  7
Edema limbs  1  11/53 (20.75%)  19
Fatigue  1  37/53 (69.81%)  187
Fever  1  6/53 (11.32%)  7
Flu-like symptoms  1  1/53 (1.89%)  1
General symptom  1  1/53 (1.89%)  2
Localized edema  1  1/53 (1.89%)  2
Pain  1  2/53 (3.77%)  3
Immune system disorders   
Hypersensitivity  1  1/53 (1.89%)  2
Immune system disorder  1  1/53 (1.89%)  35
Infections and infestations   
Bronchitis  1  3/53 (5.66%)  5
Eye infection  1  2/53 (3.77%)  4
Lip infection  1  1/53 (1.89%)  1
Peripheral nerve infection  1  1/53 (1.89%)  1
Pharyngitis  1  1/53 (1.89%)  2
Pneumonia  1  4/53 (7.55%)  4
Rhinitis infective  1  1/53 (1.89%)  1
Sinusitis  1  4/53 (7.55%)  10
Skin infection  1  4/53 (7.55%)  5
Upper respiratory infection  1  3/53 (5.66%)  4
Urinary tract infection  1  1/53 (1.89%)  1
Injury, poisoning and procedural complications   
Bruising  1  1/53 (1.89%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  1/53 (1.89%)  2
Alanine aminotransferase increased  1  11/53 (20.75%)  21
Alkaline phosphatase increased  1  6/53 (11.32%)  11
Aspartate aminotransferase increased  1  11/53 (20.75%)  18
Blood bilirubin increased  1  3/53 (5.66%)  13
Creatinine increased  1  11/53 (20.75%)  17
INR increased  1  3/53 (5.66%)  5
Laboratory test abnormal  1  1/53 (1.89%)  2
Leukocyte count decreased  1  18/53 (33.96%)  106
Lymphocyte count decreased  1  14/53 (26.42%)  49
Neutrophil count decreased  1  21/53 (39.62%)  156
Platelet count decreased  1  36/53 (67.92%)  203
Weight loss  1  8/53 (15.09%)  13
Metabolism and nutrition disorders   
Anorexia  1  16/53 (30.19%)  48
Blood glucose increased  1  13/53 (24.53%)  67
Blood uric acid increased  1  4/53 (7.55%)  16
Dehydration  1  2/53 (3.77%)  2
Serum albumin decreased  1  10/53 (18.87%)  27
Serum calcium decreased  1  9/53 (16.98%)  41
Serum phosphate decreased  1  6/53 (11.32%)  28
Serum potassium decreased  1  3/53 (5.66%)  4
Serum potassium increased  1  3/53 (5.66%)  6
Serum sodium decreased  1  8/53 (15.09%)  12
Serum sodium increased  1  1/53 (1.89%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/53 (5.66%)  20
Back pain  1  2/53 (3.77%)  7
Bone pain  1  3/53 (5.66%)  3
Muscle weakness  1  6/53 (11.32%)  9
Muscle weakness lower limb  1  1/53 (1.89%)  5
Musculoskeletal disorder  1  1/53 (1.89%)  1
Myalgia  1  3/53 (5.66%)  3
Pain in extremity  1  3/53 (5.66%)  7
Nervous system disorders   
Ataxia  1  3/53 (5.66%)  3
Cognitive disturbance  1  1/53 (1.89%)  1
Dizziness  1  14/53 (26.42%)  33
Dysgeusia  1  3/53 (5.66%)  6
Extrapyramidal disorder  1  2/53 (3.77%)  8
Headache  1  5/53 (9.43%)  9
Neuralgia  1  4/53 (7.55%)  13
Neurological disorder NOS  1  2/53 (3.77%)  3
Peripheral motor neuropathy  1  7/53 (13.21%)  13
Peripheral sensory neuropathy  1  33/53 (62.26%)  281
Sinus pain  1  1/53 (1.89%)  2
Trigeminal nerve disorder  1  1/53 (1.89%)  1
Psychiatric disorders   
Agitation  1  1/53 (1.89%)  1
Anxiety  1  1/53 (1.89%)  1
Confusion  1  1/53 (1.89%)  1
Depression  1  3/53 (5.66%)  5
Insomnia  1  5/53 (9.43%)  6
Psychosis  1  1/53 (1.89%)  1
Renal and urinary disorders   
Urinary frequency  1  1/53 (1.89%)  1
Urinary incontinence  1  1/53 (1.89%)  1
Urinary retention  1  1/53 (1.89%)  1
Urogenital disorder  1  1/53 (1.89%)  3
Reproductive system and breast disorders   
Testicular pain  1  1/53 (1.89%)  6
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  4/53 (7.55%)  4
Cough  1  15/53 (28.30%)  23
Dyspnea  1  20/53 (37.74%)  43
Epistaxis  1  2/53 (3.77%)  2
Pharyngolaryngeal pain  1  1/53 (1.89%)  1
Pleural effusion  1  1/53 (1.89%)  1
Pneumonitis  1  1/53 (1.89%)  2
Respiratory disorder  1  2/53 (3.77%)  2
Voice alteration  1  3/53 (5.66%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  1/53 (1.89%)  1
Dry skin  1  3/53 (5.66%)  5
Hand-and-foot syndrome  1  2/53 (3.77%)  5
Nail disorder  1  1/53 (1.89%)  1
Petechiae  1  1/53 (1.89%)  1
Pruritus  1  11/53 (20.75%)  34
Rash acneiform  1  1/53 (1.89%)  1
Rash desquamating  1  14/53 (26.42%)  27
Skin disorder  1  4/53 (7.55%)  5
Skin ulceration  1  1/53 (1.89%)  1
Sweating  1  6/53 (11.32%)  10
Vascular disorders   
Hypertension  1  2/53 (3.77%)  2
Hypotension  1  10/53 (18.87%)  16
Thrombosis  1  2/53 (3.77%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vicki Morrison, M.D.
Organization: Veterans Affairs Medical Center/University of Minnesota
EMail: morri002@umn.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00553644     History of Changes
Other Study ID Numbers: NCI-2009-00483
NCI-2009-00483 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000573827
CALGB 50501 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-50501 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 2007
First Posted: November 5, 2007
Results First Submitted: January 6, 2014
Results First Posted: February 20, 2014
Last Update Posted: October 30, 2018