20 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response RatePrimary· From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.
CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
87.5
Time to ResponseSecondary· From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.
Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).
CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
1.97
0.9 – 13.8
Duration of ResponseSecondary· From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.
Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
NA
10.550 – NA
Progression Free Survival (PFS)Secondary· From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.
PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
NA
NA – NA
Overall Survival (OS)Secondary· From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months
The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
17.71
17.710 – NA
Number of Participants With Adverse EventsSecondary· From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks
An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Termin
Any adverse event
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
26
TEAE related to study drug
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
25
TEAE related to Lenalidomide
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
25
TEAE related to Dexamethasone
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
20
Grade 3-4 adverse event
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
18
Grade 3-4 adverse event related to any study drug
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
15
Grade 3-4 adverse event related to Lenalidomide
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
15
Grade 3-4 adverse event related to Dexamethasone
Group
Value
95% CI
Lenalidomide Plus Dexamethasone
4
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 8 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01698801.