Trial · NCT00689936
Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
NCT00689936, Phase 3, Completed, Celgene; results first posted 2017-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma. Trials, record NCT00689936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00689936
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma
- NCT number
- NCT00689936
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,623 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Multiple Myeloma
- Interventions
- Lenalidomide and low-dose dexamethasone, Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles, Melphalan, Prednisone and Thalidomide
- First posted
- 2008-06-04
- Last updated
- 2019-11-20
- Other registries' IDs
- eudract:2007-004823-39
- Results first posted
- 2017-08-11
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months. | PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). |
| Primary | Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months | PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). |
| Secondary | Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months | Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive. |
| Secondary | Percentage of Participants With an Objective Response Based on IRAC Review | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is 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; A PR is: ≥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 size of soft tissue plasmacytomas. |
| Secondary | Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is 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; A PR is: ≥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 size of soft tissue plasmacytomas. |
| Secondary | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months | Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. |
| Secondary | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis | Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months | Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. |
| Secondary | Time to First Response Based on the Review by the IRAC | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. |
| Secondary | Time to First Response Based on the Investigator Assessment at the Time of Final Analysis | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm. | The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. |
| Secondary | Kaplan Meier Estimates of Time to Treatment Failure (TTF) | From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months. | TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months. | The intent to treat (ITT) population included all participants who were randomized, independent of whether they received study treatment or not. | months | MEDIAN |
| PRIMARY | Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months | The intent to treat population included all participants who were randomized, independent of whether they received study treatment or not. | months | MEDIAN |
| SECONDARY | Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months | ITT population included all participants who were randomized, independent of whether they received study treatment or not. | months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response Based on IRAC Review | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | ITT population includes all participants who were randomized, independent of whether they received study treatment or not. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | ITT population includes all participants who were randomized, independent of whether they received study treatment or not. | percentage of participants | NUMBER |
| SECONDARY | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months | Study participants with at least a PR | months | MEDIAN |
| SECONDARY | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis | Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months | Study participants with at least a PR | months | MEDIAN |
| SECONDARY | Time to First Response Based on the Review by the IRAC | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm | Participants who had at least a PR. | months | MEDIAN |
| SECONDARY | Time to First Response Based on the Investigator Assessment at the Time of Final Analysis | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm. | Participants who had at least a PR. | months | MEDIAN |
| SECONDARY | Kaplan Meier Estimates of Time to Treatment Failure (TTF) | From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months. | ITT population includes participants who were randomized, independent of whether they received study treatment or not | months | MEDIAN |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group831
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | Lenalidomide and Low-Dose Dexamethasone (Rd) | 25.5 | 95% Confidence Interval 20.7 to 29.4 | months | |
| Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | Lenalidomide and Dexamethasone Rd18 | 20.7 | 95% Confidence Interval 19.4 to 22.0 | months | |
| Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) | Melphalan + Prednisone + Thalidomide (MPT) | 21.2 | 95% Confidence Interval 19.3 to 23.2 | months | |
| Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | Lenalidomide and Low-Dose Dexamethasone (Rd) | 26.0 | 95% Confidence Interval 20.7 to 29.7 | months | |
| Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | Lenalidomide and Dexamethasone Rd18 | 21.0 | 95% Confidence Interval 19.7 to 22.4 | months | |
| Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis | Melphalan + Prednisone + Thalidomide (MPT) | 21.9 | 95% Confidence Interval 19.8 to 23.9 | months | |
| Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | Lenalidomide and Low-Dose Dexamethasone (Rd) | 59.1 | 95% Confidence Interval 53.9 to 65.9 | months | |
| Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | Lenalidomide and Dexamethasone Rd18 | 62.3 | 95% Confidence Interval 53.6 to 68.7 | months | |
| Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) | Melphalan + Prednisone + Thalidomide (MPT) | 49.1 | 95% Confidence Interval 44.3 to 53.5 | months | |
| Percentage of Participants With an Objective Response Based on IRAC Review | Lenalidomide and Low-Dose Dexamethasone (Rd) | 75.1 | percentage of participants |
1 to 10 of 831Source ClinicalTrials.gov
See all 831 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Active Treatment Phase | STARTED | Lenalidomide and Low-Dose Dexamethasone (Rd) | 535 | |
| Active Treatment Phase | STARTED | Lenalidomide and Dexamethasone Rd18 | 541 | |
| Active Treatment Phase | STARTED | Melphalan + Prednisone + Thalidomide (MPT) | 547 | |
| Active Treatment Phase | Safety Population | Lenalidomide and Low-Dose Dexamethasone (Rd) | 532 | |
| Active Treatment Phase | Safety Population | Lenalidomide and Dexamethasone Rd18 | 540 | |
| Active Treatment Phase | Safety Population | Melphalan + Prednisone + Thalidomide (MPT) | 541 | |
| Active Treatment Phase | Untreated | Lenalidomide and Low-Dose Dexamethasone (Rd) | 3 | |
| Active Treatment Phase | Untreated | Lenalidomide and Dexamethasone Rd18 | 1 | |
| Active Treatment Phase | Untreated | Melphalan + Prednisone + Thalidomide (MPT) | 6 | |
| Active Treatment Phase | COMPLETED | Lenalidomide and Low-Dose Dexamethasone (Rd) | 0 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events2,115
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Lenalidomide and Low-Dose Dexamethasone (Rd) | 237 | 532 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Lenalidomide and Dexamethasone (Rd18) | 191 | 540 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Melphalan + Prednisone + Thalidomide (MPT) | 219 | 541 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Lenalidomide and Low-Dose Dexamethasone (Rd) | 66 | 532 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Lenalidomide and Dexamethasone (Rd18) | 59 | 540 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Melphalan + Prednisone + Thalidomide (MPT) | 92 | 541 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Lenalidomide and Low-Dose Dexamethasone (Rd) | 60 | 532 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Lenalidomide and Dexamethasone (Rd18) | 43 | 540 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Melphalan + Prednisone + Thalidomide (MPT) | 71 | 541 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Lenalidomide and Low-Dose Dexamethasone (Rd) | 194 | 532 |
1 to 10 of 2,115Source ClinicalTrials.gov
See all 2,115 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide and Low-Dose Dexamethasone (Rd) | ||
| Total, all-cause mortality | Lenalidomide and Dexamethasone (Rd18) | ||
| Total, all-cause mortality | Melphalan + Prednisone + Thalidomide (MPT) | ||
| Total, other adverse events | Lenalidomide and Low-Dose Dexamethasone (Rd) | 523 | 532 |
| Total, other adverse events | Lenalidomide and Dexamethasone (Rd18) | 532 | 540 |
| Total, other adverse events | Melphalan + Prednisone + Thalidomide (MPT) | 532 | 541 |
| Total, serious adverse events | Lenalidomide and Low-Dose Dexamethasone (Rd) | 378 | 532 |
| Total, serious adverse events | Lenalidomide and Dexamethasone (Rd18) | 308 | 540 |
| Total, serious adverse events | Melphalan + Prednisone + Thalidomide (MPT) | 270 | 541 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT00689936/registered?page=2