Trial · NCT01208662
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
NCT01208662, Phase 3, Active not recruiting, Paul Richardson, MD; results first posted 2023-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65. Trials, record NCT01208662. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01208662
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
- NCT number
- NCT01208662
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 729 participants, actual
- Lead sponsor
- Paul Richardson, MD
- Conditions
- Multiple Myeloma
- Interventions
- Lenalidomide, Bortezomib, Dexamethasone, Autologous Stem Cell Transplant
- First posted
- 2010-09-24
- Last updated
- 2026-01-22
- Results first posted
- 2023-12-18
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression-Free Survival (PFS) | On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) PFS follow-up was 70 and 129 months. | PFS was estimated using the Kaplan-Meier (KM) method and defined as time from randomization to the earlier of disease progression (PD) as determined by central review or death from any cause (events). Patients who started non-protocol therapy (NPT) were censored at the date of NPT initiation if available or date treatment ended if date of NPT was missing. Deaths occurring beyond 1 year from the date last known progression-free are not counted as events and censored at date of last disease evaluation. Patients who had not started NPT, progressed, or died were censored at the date of last disease evaluation. PD was based upon the International Myeloma Working Group (IMWG) uniform response criteria. \[Kumar S, et al Lancet Oncol 2016;17(8):e328-e346\]. |
| Secondary | Partial Response (PR) Rate | Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort. | The PR rate is the percentage of participants achieving PR or better on treatment and was evaluated based on the IMWG criteria. PR was defined as \> 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by \> 90% or to \< 200mg per 24 hours. If the serum and urine M-protein are unmeasurable, a \> 50% decrease in the difference between involved and uninvolved free light chain levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, \>50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \> 30%. In addition to the above listed criteria, if present at baseline, a \> 50% reduction in the size of soft tissue plasmacytomas was also required. Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes. |
| Secondary | Very Good Partial Response (VGPR) Rate | Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 134 months in this study cohort. | The VGPR rate is the percentage of participants achieving VGPR or better on treatment and was evaluated based on IMWG criteria. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 hours. |
| Secondary | Complete Response (CR) Rate | Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 134 months in this study cohort. | The CR rate is the percentage of participants achieving CR or better on treatment and was evaluated based on IMWG criteria. CR was defined as the negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Confirmation with repeat bone marrow biopsy was not needed. |
| Secondary | Median Duration of Response: Partial Response (DOR PR) | On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) DOR PR follow-up was 62.9 and 122.9 months. | DOR PR was estimated using the KM method and defined as the time from documented best response as CR to documented disease progression per IMWG criteria. Patients who have not progressed or died were censored at the date last known progression-free. |
| Secondary | 5-Year Time to Progression (TTP) | On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median TTP follow-up was 70 months. The probability estimate is at 5 years. | TTP was estimated using the KM method and defined as time from randomization to time of documented IMWG disease progression or censoring time (time of last disease evaluation for those alive, time to death among those who died). Patients initiating non-protocol therapy prior to progression or death were censored at the date of non-protocol therapy in the TTP analysis. The 5-year TTP endpoint is a probability. |
| Secondary | 5-Year Overall Survival (OS) | In long-term follow-up, survival follow-up every 2 months until death. Median (maximum) OS follow-up was 76 and 129 months.The probability estimate is at 5 years. | OS was estimated using the KM method and defined as time from randomization to death due to any cause. Patients alive were censored at date last known alive. The 5-year OS endpoint is a probability. |
| Secondary | Grade 3 or Higher Treatment-Related Non-Hematologic Adverse Event (AE) Rate | AEs was assessed every cycle on treatment. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort. | Safety was evaluated throughout trial treatment, including ASCT, and through 30 days after receipt of the last dose of a trial drug. Treatment attribution and grade were based on the NCI CTCAE v4. The Grade 3 or Higher Treatment-Related Non-Hematologic AE Rate is percentage of participants who experienced any grade 3-5 treatment-related (possible, probable or definite attribution) non-hematologic adverse event based on CTCAEv4 as reported on case report forms. The difference in the rate of all grade 3 or higher toxicities was compared between the two groups using Fisher's exact test. |
| Secondary | 5-year Cumulative Incidence of Second Primary Malignancy (SPM) | 5 years | Second primary malignancy (SPM) is defined as the development of another new, unrelated cancer, regardless of treatment for previous malignancy attribution. The cumulative incidence of SPMs was estimated with death as a competing risk. SPMs were collected using an SAE form or MEDWATCH 3500A form, with intensity determined by using the NCI CTCAE version 4 as a guideline. |
| Secondary | Median Treatment Duration | Up to 134 months | Treatment duration estimated using the KM method is defined as the time from registration (C1) to the time off treatment (event) or censored at date of last treatment. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression-Free Survival (PFS) | On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) PFS follow-up was 70 and 129 months. | The analysis population is comprised of all randomized participants. | months | MEDIAN |
| SECONDARY | Partial Response (PR) Rate | Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort. | The analysis population is comprised of all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Very Good Partial Response (VGPR) Rate | Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 134 months in this study cohort. | The analysis population is comprised of all randomized participants. | percentage of patients | NUMBER |
| SECONDARY | Complete Response (CR) Rate | Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 134 months in this study cohort. | The analysis population is comprised of all randomized patients. | percentage of patients | NUMBER |
| SECONDARY | Median Duration of Response: Partial Response (DOR PR) | On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) DOR PR follow-up was 62.9 and 122.9 months. | The analysis population is comprised of all randomized participants who achieved PR. | months | MEDIAN |
| SECONDARY | 5-Year Time to Progression (TTP) | On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median TTP follow-up was 70 months. The probability estimate is at 5 years. | The analysis population is comprised of all randomized participants. | percent probability | NUMBER |
| SECONDARY | 5-Year Overall Survival (OS) | In long-term follow-up, survival follow-up every 2 months until death. Median (maximum) OS follow-up was 76 and 129 months.The probability estimate is at 5 years. | The analysis population is comprised of all randomized participants. | percent probability | NUMBER |
| SECONDARY | Grade 3 or Higher Treatment-Related Non-Hematologic Adverse Event (AE) Rate | AEs was assessed every cycle on treatment. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort. | The analysis population comprised of all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | 5-year Cumulative Incidence of Second Primary Malignancy (SPM) | 5 years | The analysis population is comprised of all randomized participants. | percentage of patients | NUMBER |
| SECONDARY | Median Treatment Duration | Up to 134 months | The analysis population is comprised of all randomized participants. | months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression-Free Survival (PFS) | RVD Alone | 46.2 | 95% Confidence Interval 38.1 to 53.7 | months | |
| Median Progression-Free Survival (PFS) | RVD Plus ASCT | 67.5 | 95% Confidence Interval 58.6 to NA | months | |
| Partial Response (PR) Rate | RVD Alone | 95 | 99.29% Confidence Interval 91.0 to 97.5 | percentage of participants | |
| Partial Response (PR) Rate | RVD Plus ASCT | 97.5 | 99.29% Confidence Interval 94.5 to 99.2 | percentage of participants | |
| Very Good Partial Response (VGPR) Rate | RVD Alone | 79.6 | 95% Confidence Interval 73.3 to 85.0 | percentage of patients | |
| Very Good Partial Response (VGPR) Rate | RVD Plus ASCT | 82.7 | 95% Confidence Interval 76.8 to 87.7 | percentage of patients | |
| Complete Response (CR) Rate | RVD Alone | 42.0 | 95% Confidence Interval 35.0 to 49.3 | percentage of patients | |
| Complete Response (CR) Rate | RVD Plus ASCT | 46.8 | 95% Confidence Interval 39.8 to 54.0 | percentage of patients | |
| Median Duration of Response: Partial Response (DOR PR) | RVD Alone | 38.9 | 95% Confidence Interval 30.8 to 45.6 | months | |
| Median Duration of Response: Partial Response (DOR PR) | RVD Plus ASCT | 56.4 | 95% Confidence Interval 47.4 to 75.8 | months |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction and Consolidation | STARTED | RVD Alone | 357 | |
| Induction and Consolidation | STARTED | RVD Plus ASCT | 365 | |
| Induction and Consolidation | STARTED | RVD Cycle 1 Only | 7 | |
| Induction and Consolidation | Randomized | RVD Alone | 357 | |
| Induction and Consolidation | Randomized | RVD Plus ASCT | 365 | |
| Induction and Consolidation | Randomized | RVD Cycle 1 Only | 0 | |
| Induction and Consolidation | Underwent Stem Cell Mobilization | RVD Alone | 324 | |
| Induction and Consolidation | Underwent Stem Cell Mobilization | RVD Plus ASCT | 330 | |
| Induction and Consolidation | Underwent Stem Cell Mobilization | RVD Cycle 1 Only | 0 | |
| Induction and Consolidation | COMPLETED | RVD Alone | 291 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events4,917
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 | Abcess | Infections and infestations | RVD Alone | 1 | 357 | |
| other | Abcess | Infections and infestations | RVD Plus ASCT | 0 | 365 | |
| other | Abcess | Infections and infestations | RVD Cycle 1 Only | 0 | 7 | |
| other | Abdominal crampy pains | Gastrointestinal disorders | RVD Alone | 0 | 357 | |
| other | Abdominal crampy pains | Gastrointestinal disorders | RVD Plus ASCT | 1 | 365 | |
| other | Abdominal crampy pains | Gastrointestinal disorders | RVD Cycle 1 Only | 0 | 7 | |
| other | Abdominal discomfort | Gastrointestinal disorders | RVD Alone | 8 | 357 | |
| other | Abdominal discomfort | Gastrointestinal disorders | RVD Plus ASCT | 20 | 365 | |
| other | Abdominal discomfort | Gastrointestinal disorders | RVD Cycle 1 Only | 0 | 7 | |
| other | Abdominal distension | Gastrointestinal disorders | RVD Alone | 26 | 357 |
1 to 10 of 4,917Source ClinicalTrials.gov
See all 4,917 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RVD Alone | 89 | 357 |
| Total, all-cause mortality | RVD Plus ASCT | 88 | 365 |
| Total, all-cause mortality | RVD Cycle 1 Only | 1 | 7 |
| Total, other adverse events | RVD Alone | 343 | 357 |
| Total, other adverse events | RVD Plus ASCT | 345 | 365 |
| Total, other adverse events | RVD Cycle 1 Only | 7 | 7 |
| Total, serious adverse events | RVD Alone | 279 | 357 |
| Total, serious adverse events | RVD Plus ASCT | 344 | 365 |
| Total, serious adverse events | RVD Cycle 1 Only | 4 | 7 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| RVD Alone vs RVD Plus ASCT: Subsequent Therapy Rate |
Source Trial comparisons
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01208662
GET https://conductscience.org/api/trials/v1/NCT01208662/results?page=2