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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00420849




Registration number
NCT00420849
Ethics application status
Date submitted
9/01/2007
Date registered
11/01/2007
Date last updated
21/05/2012

Titles & IDs
Public title
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Scientific title
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Secondary ID [1] 0 0
2006-002517-12
Secondary ID [2] 0 0
CC-5013-MM-018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Dexamethasone

Experimental: Lenalidomide plus Dexamethasone - 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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.


Treatment: Drugs: Lenalidomide
Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles.

Treatment: Drugs: Dexamethasone
Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment
Timepoint [1] 0 0
up to 123 weeks
Secondary outcome [1] 0 0
Participants With Adverse Events of Special Interest: Peripheral Neuropathy
Timepoint [1] 0 0
up to 124 weeks
Secondary outcome [2] 0 0
Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)
Timepoint [2] 0 0
up to 124 weeks
Secondary outcome [3] 0 0
Participants With Adverse Events of Special Interest: Venous Thromboembolic Events
Timepoint [3] 0 0
up to 124 weeks
Secondary outcome [4] 0 0
Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)
Timepoint [4] 0 0
up to 124 weeks
Secondary outcome [5] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale
Timepoint [5] 0 0
Baseline (Day 0), Week 24
Secondary outcome [6] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale
Timepoint [6] 0 0
Baseline (Day 0), Week 24
Secondary outcome [7] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale
Timepoint [7] 0 0
Baseline (Day 0), Week 24
Secondary outcome [8] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale
Timepoint [8] 0 0
Baseline (Day 0), Week 24
Secondary outcome [9] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale
Timepoint [9] 0 0
Baseline (Day 0), Week 24
Secondary outcome [10] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
Timepoint [10] 0 0
Baseline (Day 0), Week 24
Secondary outcome [11] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale
Timepoint [11] 0 0
Baseline (Day 0), Week 24
Secondary outcome [12] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale
Timepoint [12] 0 0
Baseline (Day 0), Week 24
Secondary outcome [13] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale
Timepoint [13] 0 0
Baseline (Day 0), Week 24
Secondary outcome [14] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale
Timepoint [14] 0 0
Baseline (Day 0), Week 24
Secondary outcome [15] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale
Timepoint [15] 0 0
Baseline (Day 0), Week 24
Secondary outcome [16] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale
Timepoint [16] 0 0
Baseline (Day 0), Week 24
Secondary outcome [17] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale
Timepoint [17] 0 0
Baseline (Day 0), Week 24
Secondary outcome [18] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale
Timepoint [18] 0 0
Baseline (Day 0), Week 24
Secondary outcome [19] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale
Timepoint [19] 0 0
Baseline (Day 0), Week 24
Secondary outcome [20] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
Timepoint [20] 0 0
Baseline (Day 0), Week 24
Secondary outcome [21] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale
Timepoint [21] 0 0
Baseline (Day 0), Week 24
Secondary outcome [22] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
Timepoint [22] 0 0
Baseline (Day 0), Week 24
Secondary outcome [23] 0 0
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
Timepoint [23] 0 0
Baseline (Day 0), Week 24

Eligibility
Key inclusion criteria
* Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.
* Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to baseline.
* Females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or lactating females

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
587
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Mater Private Centre for Haematology & Oncology - South Brisbane
Recruitment postcode(s) [1] 0 0
QLD 4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Montlearstrasse 37
Country [2] 0 0
Ireland
State/province [2] 0 0
Dublin
Country [3] 0 0
Spain
State/province [3] 0 0
Salamanca
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Knight, MD
Address 0 0
Celgene Therapeutic Area Head
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Yong K, Alegre Amor A, Browne P, Cavenagh J, Dodds... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00420849