Trial · NCT01568866
Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
NCT01568866, Phase 3, Completed, Amgen; results first posted 2015-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients. Trials, record NCT01568866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01568866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients
- NCT number
- NCT01568866
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 929 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Multiple Myeloma
- Interventions
- Carfilzomib, Bortezomib, Dexamethasone
- First posted
- 2012-04-02
- Last updated
- 2022-11-14
- Other registries' IDs
- eudract:2012-000128-16
- Results first posted
- 2015-12-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively | Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored. |
| Secondary | Overall Survival | From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively. | Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive). Median overall survival was estimated using the Kaplan-Meier method. |
| Secondary | Overall Response | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. | Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR). sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein \<100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to \< 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. |
| Secondary | Duration of Response | From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively. | Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored. |
| Secondary | Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. | Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms. Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death. |
| Secondary | Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF) | Baseline and 24 weeks | A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%. For participants with LVEF \> 55% at baseline, a significant change was defined as a decrease in LVEF to \< 45%. |
| Secondary | Change From Baseline in Right Ventricular Fractional Area Change (FAC) | Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). | Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram. |
| Secondary | Change From Baseline in Pulmonary Artery Systolic Pressure (PASP) | Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). | Pulmonary artery pressure was measured using transthoracic echocardiogram. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively | Intent-to-treat population | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively. | Intent-to-treat population | months | MEDIAN |
| SECONDARY | Overall Response | Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively. | Intent-to-treat population with an overall response | months | MEDIAN |
| SECONDARY | Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group. | Safety population (all participants who received at least 1 dose of study treatment) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF) | Baseline and 24 weeks | Cardiopulmonary Safety Evaluable subgroup (all randomized participants who enrolled in the cardiopulmonary substudy with evaluable baseline echocardiogram scans per the central laboratory) and with both baseline and at least one post-baseline LVEF measurement within 24 weeks. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Right Ventricular Fractional Area Change (FAC) | Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). | Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit. | percent fractional area change | MEAN |
| SECONDARY | Change From Baseline in Pulmonary Artery Systolic Pressure (PASP) | Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group). | Cardiopulmonary Safety Evaluable subgroup with available PASP data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Bortezomib + DEX | 9.4 | 95% Confidence Interval 8.4 to 10.4 | months | |
| Progression-free Survival | Carfilzomib + DEX | 18.7 | 95% Confidence Interval 15.6 to NA | months | |
| Overall Survival | Bortezomib + DEX | 40.0 | 95% Confidence Interval 32.6 to 42.3 | months | |
| Overall Survival | Carfilzomib + DEX | 47.6 | 95% Confidence Interval 42.5 to NA | months | |
| Overall Response | Bortezomib + DEX | 62.6 | 95% Confidence Interval 58.0 to 67.0 | percentage of participants | |
| Overall Response | Carfilzomib + DEX | 76.9 | 95% Confidence Interval 72.8 to 80.7 | percentage of participants | |
| Duration of Response | Bortezomib + DEX | 10.4 | 95% Confidence Interval 9.3 to 13.8 | months | |
| Duration of Response | Carfilzomib + DEX | 21.3 | 95% Confidence Interval 21.3 to NA | months | |
| Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | Bortezomib + DEX | 32.0 | 95% Confidence Interval 27.7 to 36.3 | percentage of participants | |
| Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | Carfilzomib + DEX | 6.0 | 95% Confidence Interval 3.9 to 8.2 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bortezomib + DEX | 465 | |
| Overall Study | STARTED | Carfilzomib + DEX | 464 | |
| Overall Study | Received Treatment | Bortezomib + DEX | 456 | |
| Overall Study | Received Treatment | Carfilzomib + DEX | 463 | |
| Overall Study | COMPLETED | Bortezomib + DEX | 27 | |
| Overall Study | COMPLETED | Carfilzomib + DEX | 48 | |
| Overall Study | NOT COMPLETED | Bortezomib + DEX | 438 | |
| Overall Study | NOT COMPLETED | Carfilzomib + DEX | 416 |
Source ClinicalTrials.gov
Adverse events758
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 | Bortezomib | 129 | 456 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Carfilzomib | 196 | 463 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Bortezomib | 25 | 456 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Carfilzomib | 31 | 463 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Bortezomib | 26 | 456 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Carfilzomib | 27 | 463 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Bortezomib | 83 | 456 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Carfilzomib | 100 | 463 | |
| other | CATARACT | Eye disorders | Bortezomib | 17 | 456 | |
| other | CATARACT | Eye disorders | Carfilzomib | 32 | 463 |
1 to 10 of 758Source ClinicalTrials.gov
See all 758 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bortezomib | ||
| Total, all-cause mortality | Carfilzomib | ||
| Total, other adverse events | Bortezomib | 435 | 456 |
| Total, other adverse events | Carfilzomib | 446 | 463 |
| Total, serious adverse events | Bortezomib | 182 | 456 |
| Total, serious adverse events | Carfilzomib | 272 | 463 |
Source ClinicalTrials.gov
Papers21
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 |
|---|
| Bortezomib vs Carfilzomib: 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/NCT01568866
GET https://conductscience.org/api/trials/v1/NCT01568866/results?page=2