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Type(s) of Cancer
Multiple Myeloma
Study Phase
Phase 3
Study Completion Date
January 2019
NCT01169337Uploaded 04-01-2023
Access via NCI by Request
PDS UID: nci-data-514
Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma
Provider Information
Provider Data DescriptionThere are five submissions for PMID 31652094. This dataset, NCT01169337-D1, contains baseline, treatment, and efficacy data. Dataset NCT01169337-D2 contains treatment dosage. Dataset NCT01169337-D3 contains post-baseline toxicities. Dataset NCT01169337-D4 contains patient-reported outcome quality of life data. Dataset NCT01169337-D5 contains data on basis of progression.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase II/III trial studies how well lenalidomide works and compares it to observation in treating patients with asymptomatic high-risk asymptomatic (smoldering) multiple myeloma. Biological therapies such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether lenalidomide is effective in treating patients with high-risk smoldering multiple myeloma than observation alone.
ConditionsLight Chain Deposition Disease
Smoldering Multiple Myeloma
Intervention TypeOther: Clinical Observation
Drug: Lenalidomide
Other: Quality-of-Life Assessment
Drug(s)Drug: Lenalidomide
Total Enrolled226
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (lenalidomide) - Experimental
Arm B (observation) - Active Comparator
Secondary IDNCI-2011-02057
PubMed (PMID)31652094
Collaborator(s)N/A
Region(s)United States
Ireland
Puerto Rico
Age Range18 Years and older (Adult, Older Adult)
Files: NCT01169337-D1
Data DictionaryNCT01169337-D1-Data-Dictionary_0.pdf
DATANCT01169337-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01169337-D2
Data DictionaryNCT01169337-D2-Data-Dictionary_0.pdf
DATANCT01169337-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT01169337-D3
Data DictionaryNCT01169337-D3-Data-Dictionary_0.pdf
DATANCT01169337-D3-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01169337-D4
Data DictionaryNCT01169337-D4-Data-Dictionary_0.pdf
DATANCT01169337-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT01169337-D5
Data DictionaryNCT01169337-D5-Data-Dictionary_1.pdf
DATANCT01169337-D5-Dataset.csv
OTHERREADME.pdf
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