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Type(s) of Cancer
Multiple Myeloma
Study Phase
Phase 3
Study Completion Date
2016-07-01
NCT00644228Uploaded 08-21-2019
Access via NCI by Request
PDS UID: nci-data-360
A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant
Provider Information
Provider Data DescriptionThe dataset NCT00644228-D2-Dataset.csv will allow users to reproduce safety analyses included in the aforementioned publication, which compared toxicity between bortezomib, lenalidomide and low dose dexamethasone versus lenalidomide and low dose dexamethasone induction therapy for the treatment of patients with newly diagnosed multiple myeloma in the SWOG phase III trial, S0777.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
ConditionsDS Stage I Multiple Myeloma
DS Stage II Multiple Myeloma
DS Stage III Multiple Myeloma
Intervention TypeDrug: Bortezomib
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug(s)Drug: Dexamethasone
Drug: Lenalidomide
Drug: Bortezomib
Total Enrolled525
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (dexamethasone and lenalidomide) - Active Comparator
Arm II (dexamethasone, lenalidomide, bortezomib) - Experimental
Secondary IDNCI-2009-00798
PubMed (PMID)28586789
28017406
22689675
Collaborator(s)N/A
Region(s)United States
Puerto Rico
Saudi Arabia
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00644228-D2
Data DictionaryNCT00644228-D2-Data-Dictionary.pdf
DATANCT00644228-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00644228-D1
Data DictionaryNCT00644228-D1-Data-Dictionary.pdf
DATANCT00644228-D1-Dataset.csv
OTHERREADME.pdf
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