Status:
COMPLETED
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Lead Sponsor:
Celgene Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose dexamethasone. Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Pregnant or lactating females
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
587 Patients enrolled
Trial Details
Trial ID
NCT00420849
Start Date
November 1 2006
End Date
November 1 2009
Last Update
May 21 2012
Active Locations (5)
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1
The Mater Private Centre for Haematology & Oncology
South Brisbane, Australia, QLD 4101
2
Wilhelminenspital
Vienna, Montlearstrasse 37, Austria, 1160
3
St James's Hospital
Dublin, Ireland
4
H. Clínico de Salamanca
Salamanca, Spain