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Trial record 48 of 881 for:    LENALIDOMIDE

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01698801
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : December 3, 2014
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Lenalidomide
Drug: dexamethasone
Enrollment 26
Recruitment Details  
Pre-assignment Details This is an ongoing open-label, single arm, 5 year study consisting of a 28-day screening period followed by a treatment period where participants receive lenalidomide and dexamethasone until their disease progresses or the lenalidomide is discontinued for any reason. This report includes data up to the cut-off of 15 July 2014.
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Period Title: Treatment Phase
Started 26
Completed 15 [1]
Not Completed 11
Reason Not Completed
Adverse Event             4
Protocol Violation             1
Not specified             4
Withdrawal by Subject             1
Disease progression             1
[1]
Completed includes participants who continued to receive study medication and treatment is ongoing.
Period Title: Follow Up Phase
Started 11 [1]
Completed 6 [2]
Not Completed 5
Reason Not Completed
Withdrawal by Subject             1
Death             4
[1]
11 participants did not complete the study and moved into the follow up phase lasting up to 5 years.
[2]
Completed includes participants who remain in follow-up for up to 5 years from start of treatment
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population consisted of all participants enrolled independent of whether they received study treatment or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
74.2  (7.01)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
≤ 75 Years Old 14
> 75 Years Old 12
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
13
  50.0%
Male
13
  50.0%
Multiple Myeloma Stage before Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Stage I 7
Stage II 14
Stage III 5
[1]
Measure Description:

The International Staging System (ISS) divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels.

Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L);

Stage II: Neither stage I or III, meaning that either:

  • The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR
  • The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5

Stage III: Serum beta-2 microglobulin is greater than 5.5.

Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
0 = Fully Active 13
1= Restrictive but Ambulatory 7
2 = Ambulatory but Unable to Work 6
3 = Limited Self-Care 0
4 = Completely Disabled 0
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
1.Primary Outcome
Title Overall Response Rate
Hide Description

Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.

CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Time Frame From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of participants
87.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.
Method Binomial test for dichotomized response
Comments [Not Specified]
Method of Estimation Estimation Parameter Overall dichotomized response rate
Estimated Value 87.5
Confidence Interval (2-Sided) 95%
74.269 to 100
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Response
Hide Description

Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).

CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.

Time Frame From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: months
1.97
(0.9 to 13.8)
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.
Time Frame From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(10.550 to NA)
[1]
The median duration of response based on Kaplan-Meier estimate had not been reached by the 15 July 2014 data cut-off date.
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.
Time Frame From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
The median time to progression free survival based on Kaplan-Meier estimate had not been reached by the 15 July 2014 data cut-off date.
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Time Frame From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: months
17.71 [1] 
(17.710 to NA)
[1]
OS data are interim at data cutoff, with only 3 events in the study treatment phase (median follow-up 14.2 mos)
6.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
Time Frame From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
Any adverse event 26
TEAE related to study drug 25
TEAE related to Lenalidomide 25
TEAE related to Dexamethasone 20
Grade 3-4 adverse event 18
Grade 3-4 adverse event related to any study drug 15
Grade 3-4 adverse event related to Lenalidomide 15
Grade 3-4 adverse event related to Dexamethasone 4
Serious TEAE 11
Serious TEAE related to any study drug 8
Serious TEAE related to Lenalidomide 8
Serious TEAE related to Dexamethasone 3
TEAE leading to discontinuation of either drug 4
TEAE leading to discontinuation of lenalidomide 4
TEAE leading to discontinuation of dexamethasone 2
Related TEAE discontinuation of either drug 4
Related TEAE discontinuation of lenalidomide 4
Related TEAE discontinuation of dexamethasone 0
Time Frame From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description

Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle

Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 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   11/26 (42.31%) 
Blood and lymphatic system disorders   
THROMBOCYTOPENIA  1  1/26 (3.85%) 
Cardiac disorders   
CARDIAC FAILURE ACUTE  1  1/26 (3.85%) 
CORONARY ARTERY STENOSIS  1  1/26 (3.85%) 
Gastrointestinal disorders   
LOWER GASTROINTESTINAL HAEMORRHAGE  1  1/26 (3.85%) 
Hepatobiliary disorders   
HEPATIC FUNCTION ABNORMAL  1  1/26 (3.85%) 
Infections and infestations   
PNEUMONIA  1  1/26 (3.85%) 
URINARY TRACT INFECTION  1  1/26 (3.85%) 
Metabolism and nutrition disorders   
TUMOUR LYSIS SYNDROME  1  1/26 (3.85%) 
Nervous system disorders   
PRESYNCOPE  1  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders   
INTERSTITIAL LUNG DISEASE  1  1/26 (3.85%) 
PNEUMONIA ASPIRATION  1  1/26 (3.85%) 
Skin and subcutaneous tissue disorders   
TOXIC SKIN ERUPTION  1  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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   26/26 (100.00%) 
Blood and lymphatic system disorders   
ANAEMIA  1  8/26 (30.77%) 
NEUTROPENIA  1  7/26 (26.92%) 
THROMBOCYTOPENIA  1  6/26 (23.08%) 
LEUKOPENIA  1  6/26 (23.08%) 
LYMPHOPENIA  1  4/26 (15.38%) 
Eye disorders   
CATARACT  1  3/26 (11.54%) 
Gastrointestinal disorders   
CONSTIPATION  1  8/26 (30.77%) 
STOMATITIS  1  3/26 (11.54%) 
DENTAL CARIES  1  3/26 (11.54%) 
NAUSEA  1  2/26 (7.69%) 
VOMITING  1  2/26 (7.69%) 
ABDOMINAL PAIN UPPER  1  2/26 (7.69%) 
DIARRHOEA  1  2/26 (7.69%) 
General disorders   
OEDEMA PERIPHERAL  1  6/26 (23.08%) 
MALAISE  1  4/26 (15.38%) 
FACE OEDEMA  1  2/26 (7.69%) 
Hepatobiliary disorders   
HEPATIC FUNCTION ABNORMAL  1  3/26 (11.54%) 
Infections and infestations   
NASOPHARYNGITIS  1  11/26 (42.31%) 
UPPER RESPIRATORY TRACT INFECTION  1  3/26 (11.54%) 
GASTROENTERITIS  1  2/26 (7.69%) 
Injury, poisoning and procedural complications   
HEAD INJURY  1  3/26 (11.54%) 
CONTUSION  1  3/26 (11.54%) 
Fall  1  2/26 (7.69%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  2/26 (7.69%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  2/26 (7.69%) 
WEIGHT DECREASED  1  2/26 (7.69%) 
BLOOD CREATININE INCREASED  1  2/26 (7.69%) 
BLOOD UREA INCREASED  1  2/26 (7.69%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  3/26 (11.54%) 
HYPOPHOSPHATAEMIA  1  3/26 (11.54%) 
DIABETES MELLITUS  1  2/26 (7.69%) 
HYPERURICAEMIA  1  2/26 (7.69%) 
HYPOALBUMINAEMIA  1  2/26 (7.69%) 
HYPONATRAEMIA  1  2/26 (7.69%) 
Musculoskeletal and connective tissue disorders   
MUSCULAR WEAKNESS  1  3/26 (11.54%) 
BACK PAIN  1  3/26 (11.54%) 
MUSCLE SPASMS  1  2/26 (7.69%) 
MYALGIA  1  2/26 (7.69%) 
Nervous system disorders   
DYSGEUSIA  1  4/26 (15.38%) 
HYPOAESTHESIA  1  2/26 (7.69%) 
Psychiatric disorders   
INSOMNIA  1  6/26 (23.08%) 
Respiratory, thoracic and mediastinal disorders   
HICCUPS  1  4/26 (15.38%) 
DYSPNOEA  1  2/26 (7.69%) 
Skin and subcutaneous tissue disorders   
RASH  1  13/26 (50.00%) 
DRY SKIN  1  5/26 (19.23%) 
RASH MACULO-PAPULAR  1  3/26 (11.54%) 
URTICARIA  1  2/26 (7.69%) 
PRURITUS  1  3/26 (11.54%) 
ERYTHEMA  1  2/26 (7.69%) 
Vascular disorders   
HYPERTENSION  1  3/26 (11.54%) 
HYPOTENSION  1  2/26 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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.
Disclosure agreements varied; the Investigators shall not disclose any material/information disclosed by the Sponsor (Celgene KK) with the clinical trial or information obtained by conducting the clinical trial to third parties without Sponsor’s prior written approval.
Results Point of Contact
Name/Title: Senior Manager, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01698801     History of Changes
Other Study ID Numbers: CC-5013-MM-025
First Submitted: October 1, 2012
First Posted: October 3, 2012
Results First Submitted: November 25, 2014
Results First Posted: December 3, 2014
Last Update Posted: November 8, 2018