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Trial record 2 of 495 for:    LENALIDOMIDE AND every 28 days

A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00478777
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : November 3, 2011
Last Update Posted : November 3, 2011
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsed or Refractory Multiple Myeloma
Interventions Drug: Lenalidomide
Drug: dexamethasone
Enrollment 150
Recruitment Details A total of 150 participants in 37 sites in Germany were enrolled when lenalidomide became commercially available in Germany. Study completion (end of study) was the time point when participants discontinued study drug and could switch to commercial lenalidomide.
Pre-assignment Details  
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
Period Title: Overall Study
Started 150
Safety and Full Analysis Set (FAS) 144 [1]
Completed 73 [2]
Not Completed 77
Reason Not Completed
Adverse Event             29
Lack of Efficacy             23
Withdrawal by Subject             4
Death             3
Protocol Violation             3
Lost to Follow-up             3
Physician Decision             1
Intolerance of therapy             1
Lack of compliance             1
Lymphocytes infusion             1
End of therapy             2
Not treated with lenalidomide             6
[1]
6 enrolled participants did not receive lenalidomide.
[2]
10 participants had >= 6 months and 63 participants < 6 months treatment prior to study termination.
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
Overall Number of Baseline Participants 144
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants
64.7  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
Female
68
  47.2%
Male
76
  52.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 144 participants
White 142
Other 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 144 participants
144
1.Primary Outcome
Title Kaplan Meier Estimate for Time to Disease Progression
Hide Description

Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease.

Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

Time Frame up to 827 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis dataset
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
Overall Number of Participants Analyzed 144
Median (95% Confidence Interval)
Unit of Measure: days
214.0
(146 to 281)
2.Secondary Outcome
Title Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
Hide Description

Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD).

CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline.

Time Frame Up to 827 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
Overall Number of Participants Analyzed 144
Measure Type: Number
Unit of Measure: participants
Complete response (CR) 6
Partial response (PR) 97
Stable disease (SD) 30
Progressive disease (PD) 3
Not evaluable (NE) 8
CR + PR 103
CR + PR + SD 133
3.Secondary Outcome
Title Participants With Treatment-emergent Adverse Experiences (TEAEs)
Hide Description

Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.

National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.

Time Frame up to 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
Overall Number of Participants Analyzed 144
Measure Type: Number
Unit of Measure: participants
>=1 TEAE 139
>=1 TEAE related to study drug 119
>=1 NCI CTCAE grade 3 or 4 TEAE 105
>=1 NCI CTCAE grade 3 or 4 TEAE related to drug 83
>=1 serious AE (SAE) 79
>=1 study drug related SAE 48
Discontinued due to TEAE 32
Discontinued due to TEAE related to study drug 21
TEAE leading to dose reduction 35
TEAE leading to dose interruption 64
Deaths 79
4.Secondary Outcome
Title Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria
Hide Description Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.
Time Frame up to 827 days
Hide Outcome Measure Data
Hide Analysis Population Description
Values for the free light chain concentrations were determined to be invalid.
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
All-Cause Mortality
Lenalidomide Plus Dexamethasone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Plus Dexamethasone
Affected / at Risk (%)
Total   79/144 (54.86%) 
Blood and lymphatic system disorders   
Anaemia  1  5/144 (3.47%) 
Neutropenia  1  4/144 (2.78%) 
Thrombocytopenia  1  3/144 (2.08%) 
Febrile neutropenia  1  2/144 (1.39%) 
Leukopenia  1  2/144 (1.39%) 
Pancytopenia  1  1/144 (0.69%) 
Cardiac disorders   
Cardiac failure  1  3/144 (2.08%) 
Atrial fibrillation  1  2/144 (1.39%) 
Tachyarrhythmia  1  2/144 (1.39%) 
Angina pectoris  1  1/144 (0.69%) 
Arrhythmia  1  1/144 (0.69%) 
Atrial flutter  1  1/144 (0.69%) 
Bundle branch block right  1  1/144 (0.69%) 
Extrasystoles  1  1/144 (0.69%) 
Myocardial infarction  1  1/144 (0.69%) 
Pericardial effusion  1  1/144 (0.69%) 
Ventricular fibrillation  1  1/144 (0.69%) 
Ventricular tachycardia  1  1/144 (0.69%) 
Congenital, familial and genetic disorders   
Epidermolysis bullosa  1  1/144 (0.69%) 
Factor VIII deficiency  1  1/144 (0.69%) 
Ear and labyrinth disorders   
Vertigo  1  3/144 (2.08%) 
Eye disorders   
Vision blurred  1  1/144 (0.69%) 
Gastrointestinal disorders   
Diarrhoea  1  5/144 (3.47%) 
Nausea  1  3/144 (2.08%) 
Haemorrhoidal haemorrhage  1  2/144 (1.39%) 
Vomiting  1  2/144 (1.39%) 
Abdominal pain upper  1  1/144 (0.69%) 
Anal haemorrhage  1  1/144 (0.69%) 
Diarrhoea haemorrhagic  1  1/144 (0.69%) 
Duodenitis  1  1/144 (0.69%) 
Gastrointestinal haemorrhage  1  1/144 (0.69%) 
Large intestinal perforation  1  1/144 (0.69%) 
Subileus  1  1/144 (0.69%) 
Tooth disorder  1  1/144 (0.69%) 
General disorders   
Pyrexia  1  14/144 (9.72%) 
General physical health deterioration  1  6/144 (4.17%) 
Asthenia  1  2/144 (1.39%) 
Multi-organ failure  1  2/144 (1.39%) 
Chills  1  1/144 (0.69%) 
Fatigue  1  1/144 (0.69%) 
Gait disturbance  1  1/144 (0.69%) 
Orthostatic intolerance  1  1/144 (0.69%) 
Pain  1  1/144 (0.69%) 
Immune system disorders   
Acute graft versus host disease in intestine  1  1/144 (0.69%) 
Graft versus host disease  1  1/144 (0.69%) 
Infections and infestations   
Pneumonia  1  8/144 (5.56%) 
Sepsis  1  6/144 (4.17%) 
Upper respiratory tract infection  1  2/144 (1.39%) 
Bronchitis  1  1/144 (0.69%) 
Febrile infection  1  1/144 (0.69%) 
Gastrointestinal infection  1  1/144 (0.69%) 
Herpes zoster  1  1/144 (0.69%) 
Infection  1  1/144 (0.69%) 
Lung infection  1  1/144 (0.69%) 
Respiratory tract infection  1  1/144 (0.69%) 
Tooth infection  1  1/144 (0.69%) 
Urinary tract infection  1  1/144 (0.69%) 
Urosepsis  1  1/144 (0.69%) 
Injury, poisoning and procedural complications   
Humerus fracture  1  3/144 (2.08%) 
Femoral neck fracture  1  1/144 (0.69%) 
Investigations   
Haemoglobin decreased  1  1/144 (0.69%) 
Platelet count decreased  1  1/144 (0.69%) 
Protein total increased  1  1/144 (0.69%) 
White blood cell count increased  1  1/144 (0.69%) 
Metabolism and nutrition disorders   
Hypercalcaemia  1  2/144 (1.39%) 
Hyperglycaemia  1  2/144 (1.39%) 
Dehydration  1  1/144 (0.69%) 
Diabetes mellitus  1  1/144 (0.69%) 
Electrolyte imbalance  1  1/144 (0.69%) 
Hyperkalaemia  1  1/144 (0.69%) 
Hypocalcaemia  1  1/144 (0.69%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/144 (2.08%) 
Bone pain  1  2/144 (1.39%) 
Muscle spasms  1  2/144 (1.39%) 
Arthritis  1  1/144 (0.69%) 
Osteolysis  1  1/144 (0.69%) 
Pain in extremity  1  1/144 (0.69%) 
Pathological fracture  1  1/144 (0.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Multiple myeloma  1  6/144 (4.17%) 
Colon cancer  1  1/144 (0.69%) 
Colon adenoma  1  1/144 (0.69%) 
Leukaemia plasmacytic  1  1/144 (0.69%) 
Squamous cell carcinoma of skin  1  1/144 (0.69%) 
Tumour pain  1  1/144 (0.69%) 
Nervous system disorders   
Syncope  1  3/144 (2.08%) 
Dizziness  1  2/144 (1.39%) 
Grand mal convulsion  1  1/144 (0.69%) 
Headache  1  1/144 (0.69%) 
Neurological symptom  1  1/144 (0.69%) 
Neuromyopathy  1  1/144 (0.69%) 
Syncope vasovagal  1  1/144 (0.69%) 
Tremor  1  1/144 (0.69%) 
Psychiatric disorders   
Confusional state  1  2/144 (1.39%) 
Depression  1  1/144 (0.69%) 
Disorientation  1  1/144 (0.69%) 
Mental disorder due to a general medical condition  1  1/144 (0.69%) 
Psychotic disorder  1  1/144 (0.69%) 
Renal and urinary disorders   
Renal failure  1  4/144 (2.78%) 
Renal failure acute  1  3/144 (2.08%) 
Renal impairment  1  1/144 (0.69%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  4/144 (2.78%) 
Dyspnoea  1  3/144 (2.08%) 
Respiratory failure  1  2/144 (1.39%) 
Pleural effusion  1  1/144 (0.69%) 
Pulmonary oedema  1  1/144 (0.69%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/144 (0.69%) 
Vascular disorders   
Thrombosis  1  3/144 (2.08%) 
Hypotension  1  2/144 (1.39%) 
Circulatory collapse  1  1/144 (0.69%) 
Deep vein thrombosis  1  1/144 (0.69%) 
Subclavian vein thrombosis  1  1/144 (0.69%) 
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 5%
Lenalidomide Plus Dexamethasone
Affected / at Risk (%)
Total   129/144 (89.58%) 
Blood and lymphatic system disorders   
Leukopenia  1  28/144 (19.44%) 
Thromboyctopenia  1  25/144 (17.36%) 
Anaemia  1  15/144 (10.42%) 
Lymphopenia  1  14/144 (9.72%) 
Neutropenia  1  12/144 (8.33%) 
Gastrointestinal disorders   
Diarrhoea  1  22/144 (15.28%) 
Constipation  1  20/144 (13.89%) 
Nausea  1  9/144 (6.25%) 
General disorders   
Fatigue  1  33/144 (22.92%) 
Oedema peripheral  1  19/144 (13.19%) 
Pyrexia  1  18/144 (12.50%) 
Infections and infestations   
Nasopharyngitis  1  12/144 (8.33%) 
Urinary tract infection  1  9/144 (6.25%) 
Investigations   
Haemoglobin decreased  1  13/144 (9.03%) 
C-reactive protein increased  1  12/144 (8.33%) 
Metabolism and nutrition disorders   
Hyperglycaemia  1  9/144 (6.25%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  35/144 (24.31%) 
Back pain  1  13/144 (9.03%) 
Arthralgia  1  12/144 (8.33%) 
Pain in extremity  1  11/144 (7.64%) 
Muscular weakness  1  9/144 (6.25%) 
Bone pain  1  8/144 (5.56%) 
Nervous system disorders   
Dizziness  1  17/144 (11.81%) 
Tremor  1  15/144 (10.42%) 
Polyneuropathy  1  14/144 (9.72%) 
Paraesthesia  1  8/144 (5.56%) 
Psychiatric disorders   
Insomnia  1  15/144 (10.42%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  9/144 (6.25%) 
Cough  1  8/144 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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. It 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. In this case, Celgene has the right to comment and right to ask delay of publication for 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
Publications of Results:
Weisel, Katja Christina, et. al. Speed of Response with Lenalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma: First Results of the MM-019 Compassionate Use Protocol. 14th Congress of the European Hematology Association, June 2009. Haematologica 2009; 94(Suppl 2):160 abs.0397. http://www.eventure-online.com/eventure/publicAbstractView.do?id=101710&congressId=2432
Layout table for additonal information
Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT00478777     History of Changes
Other Study ID Numbers: CC-5013-MM-019
2006-004532-73 ( EudraCT Number )
First Submitted: May 23, 2007
First Posted: May 25, 2007
Results First Submitted: September 26, 2011
Results First Posted: November 3, 2011
Last Update Posted: November 3, 2011