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Type(s) of Cancer
Multiple Myeloma
Study Phase
Phase 3
Study Completion Date
2025-11-30
NCT01863550Uploaded 04-28-2023
Access via NCI by Request
PDS UID: nci-data-519
Randomized Phase III Trial of Bortezomib, Lenalidomide, and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients With Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
Provider Information
Provider Data DescriptionThere are seven different submissions for PMID 32866432 from trial E1A11. This dataset, NCT01863550-D1, contains baseline, treatment, and efficacy data. Dataset NCT01863550-D2 contains treatment dose by cycle. Dataset NCT01863550-D3 contains information related to first dose modification. Dataset NCT01863550-D4 contains toxicity data reported by case report forms. Dataset NCT01863550-D5 contains adverse events submitted via expedited reporting. Dataset NCT01863550-D6 contains secondary primary cancers. Dataset NCT01863550-D7 contains patients reported quality-of-life data.
SponsorECOG-ACRIN Cancer Research Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. 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. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma
ConditionsPlasma Cell Myeloma
Intervention TypeDrug: Bortezomib
Drug: Carfilzomib
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Other: Quality-of-Life Assessment
Drug(s)Drug: Bortezomib
Drug: Dexamethasone
Drug: Lenalidomide
Drug: Carfilzomib
Total Enrolled1087
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm A (bortezomib, lenalidomide, dexamethasone) - Experimental
Arm B (carfilzomib, lenalidomide, dexamethasone) - Experimental
Arm C (lenalidomide) - Experimental
Arm D (lenalidomide) - Experimental
Secondary IDNCI-2012-02608
PubMed (PMID)32866432
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01863550-D1
Data DictionaryNCT01863550-D1-Data-Dictionary_1.pdf
DATANCT01863550-D1-Dataset_3.csv
OTHERREADME.pdf
Files: NCT01863550-D2
Data DictionaryNCT01863550-D2-Data-Dictionary_1.pdf
DATANCT01863550-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01863550-D3
Data DictionaryNCT01863550-D3-Data-Dictionary_1.pdf
DATANCT01863550-D3-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01863550-D4
Data DictionaryNCT01863550-D4-Data-Dictionary_1.pdf
DATANCT01863550-D4-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01863550-D5
Data DictionaryNCT01863550-D5-Data-Dictionary_1.pdf
DATANCT01863550-D5-Dataset_3.csv
OTHERREADME.pdf
Files: NCT01863550-D6
Data DictionaryNCT01863550-D6-Data-Dictionary_1.pdf
DATANCT01863550-D6-Dataset_2.csv
OTHERREADME.pdf
Files: NCT01863550-D7
Data DictionaryNCT01863550-D7-Data-Dictionary_1.pdf
DATANCT01863550-D7-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01863550-D8
Data DictionaryNCT01863550-D8-Data-Dictionary_0.pdf
DATANCT01863550-D8-Dataset.csv
OTHERREADME.pdf
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