Trial · NCT01080391
Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
NCT01080391, Phase 3, Completed, Amgen; results first posted 2015-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma. Trials, record NCT01080391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01080391
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
- NCT number
- NCT01080391
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 792 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Relapsed Multiple Myeloma
- Interventions
- Dexamethasone, Lenalidomide, Carfilzomib
- First posted
- 2010-03-04
- Last updated
- 2022-09-21
- Results first posted
- 2015-07-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months. | Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date). |
| Secondary | Overall Survival | From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group. | Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier. |
| Secondary | Overall Response Rate | From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months. | Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). |
| Secondary | Disease Control Rate | From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months. | Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria). |
| Secondary | Duration of Response | From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months. | Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS. |
| Secondary | Duration of Disease Control | From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months. | Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS. |
| Secondary | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores | Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18 | Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months. | ITT analysis set comprised of all randomized participants | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group. | ITT analysis set comprised of all randomized participants | months | MEDIAN |
| SECONDARY | Overall Response Rate | From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months. | ITT analysis set comprised of all randomized participants | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate | From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months. | ITT analysis set comprised of all randomized participants | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months. | The Intent to treat (ITT) population with participantant who achieved a best overall response of PR or better. | months | MEDIAN |
| SECONDARY | Duration of Disease Control | From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months. | The Intent to treat (ITT) population with participantants who achieved disease control. | months | MEDIAN |
| SECONDARY | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores | Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18 | ITT analysis set participants with a baseline value. | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Lenalidomide and Dexamethasone (Rd) | 17.6 | 95% Confidence Interval 15.0 to 20.6 | months | |
| Progression-free Survival (PFS) | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 26.3 | 95% Confidence Interval 23.3 to 30.5 | months | |
| Overall Survival | Lenalidomide and Dexamethasone (Rd) | 40.4 | 95% Confidence Interval 33.6 to 44.4 | months | |
| Overall Survival | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 48.3 | 95% Confidence Interval 42.4 to 52.8 | months | |
| Overall Response Rate | Lenalidomide and Dexamethasone (Rd) | 66.7 | 95% Confidence Interval 61.8 to 71.3 | percentage of participants | |
| Overall Response Rate | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 87.1 | 95% Confidence Interval 83.4 to 90.3 | percentage of participants | |
| Disease Control Rate | Lenalidomide and Dexamethasone (Rd) | 87.1 | 95% Confidence Interval 83.4 to 90.3 | percentage of participants | |
| Disease Control Rate | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 92.7 | 95% Confidence Interval 89.7 to 95.0 | percentage of participants | |
| Duration of Response | Lenalidomide and Dexamethasone (Rd) | 21.2 | 95% Confidence Interval 16.7 to 25.8 | months | |
| Duration of Response | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 28.6 | 95% Confidence Interval 24.9 to 31.3 | months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenalidomide and Dexamethasone (Rd) | 396 | |
| Overall Study | STARTED | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 396 | |
| Overall Study | Treated | Lenalidomide and Dexamethasone (Rd) | 389 | |
| Overall Study | Treated | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 392 | |
| Overall Study | COMPLETED | Lenalidomide and Dexamethasone (Rd) | 389 | |
| Overall Study | COMPLETED | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 392 | |
| Overall Study | NOT COMPLETED | Lenalidomide and Dexamethasone (Rd) | 7 | |
| Overall Study | NOT COMPLETED | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 4 |
Source ClinicalTrials.gov
Adverse events904
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 Dexamethasone (Rd) | 154 | 389 | |
| other | Anaemia | Blood and lymphatic system disorders | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 166 | 392 | |
| other | Leukopenia | Blood and lymphatic system disorders | Lenalidomide and Dexamethasone (Rd) | 22 | 389 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 33 | 392 | |
| other | Neutropenia | Blood and lymphatic system disorders | Lenalidomide and Dexamethasone (Rd) | 133 | 389 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 157 | 392 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Lenalidomide and Dexamethasone (Rd) | 94 | 389 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 115 | 392 | |
| other | Cataract | Eye disorders | Lenalidomide and Dexamethasone (Rd) | 36 | 389 | |
| other | Cataract | Eye disorders | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 39 | 392 |
1 to 10 of 904Source ClinicalTrials.gov
See all 904 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide and Dexamethasone (Rd) | ||
| Total, all-cause mortality | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | ||
| Total, other adverse events | Lenalidomide and Dexamethasone (Rd) | 358 | 389 |
| Total, other adverse events | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 370 | 392 |
| Total, serious adverse events | Lenalidomide and Dexamethasone (Rd) | 221 | 389 |
| Total, serious adverse events | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 256 | 392 |
Source ClinicalTrials.gov
Papers14
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 |
|---|
| Lenalidomide and Dexamethasone (Rd) vs Carfilzomib, Lenalidomide, and Dexamethasone (CRd): serious adverse events |
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/NCT01080391
GET https://conductscience.org/api/trials/v1/NCT01080391/results?page=2