Trial · NCT01818752
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
NCT01818752, Phase 3, Completed, Amgen; results first posted 2017-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma. Trials, record NCT01818752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01818752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
- NCT number
- NCT01818752
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 955 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Multiple Myeloma
- Interventions
- Carfilzomib, Bortezomib, Melphalan, Prednisone
- First posted
- 2013-03-26
- Last updated
- 2019-08-26
- Other registries' IDs
- eudract:2012-005283-97
- Results first posted
- 2017-08-01
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 until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively. | Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression. Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner. |
| Secondary | Overall Survival (OS) | From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively. | Overall survival (OS) was 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 on the date the patient was last known to be alive. Median overall survival was estimated using the Kaplan-Meier method. |
| Secondary | Overall Response Rate | Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively. | Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). 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 | Complete Response Rate | Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively. | Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response. 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. |
| Secondary | Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups. | 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 | European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores | Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48 | The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL. |
| Secondary | Number of Participants With Adverse Events | From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups. | Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal. A serious adverse event is an adverse event that met 1 or more of the following criteria: * Death * Life-threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above. Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship. |
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 until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively. | The intent-to-treat population included all randomized participants. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively. | Intent-to-treat population | months | MEDIAN |
| SECONDARY | Overall Response Rate | Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively. | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate | Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively. | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups. | The safety population included all randomized participants who received at least 1 dose of any study treatment (i.e., carfilzomib, bortezomib, melphalan, or prednisone). | percentage of participants | NUMBER |
| SECONDARY | European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores | Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48 | Intent-to treat population with available data at each time point. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events | From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups. | Safety population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
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) | Bortezomib, Melphalan, Prednisone | 22.1 | 95% Confidence Interval 20.8 to 24.4 | months | |
| Progression-Free Survival (PFS) | Carfilzomib, Melphalan, Prednisone | 22.3 | 95% Confidence Interval 20.9 to 26.7 | months | |
| Overall Survival (OS) | Bortezomib, Melphalan, Prednisone | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Carfilzomib, Melphalan, Prednisone | NA | 95% Confidence Interval 31.5 to NA | months | |
| Overall Response Rate | Bortezomib, Melphalan, Prednisone | 78.8 | 95% Confidence Interval 74.9 to 82.4 | percentage of participants | |
| Overall Response Rate | Carfilzomib, Melphalan, Prednisone | 84.3 | 95% Confidence Interval 80.7 to 87.5 | percentage of participants | |
| Complete Response Rate | Bortezomib, Melphalan, Prednisone | 23.1 | 95% Confidence Interval 19.4 to 27.1 | percentage of participants | |
| Complete Response Rate | Carfilzomib, Melphalan, Prednisone | 25.9 | 95% Confidence Interval 22.1 to 30.1 | percentage of participants | |
| Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | Bortezomib, Melphalan, Prednisone | 35.1 | 95% Confidence Interval 30.8 to 39.6 | percentage of participants | |
| Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy | Carfilzomib, Melphalan, Prednisone | 2.5 | 95% Confidence Interval 1.3 to 4.4 | percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 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, Melphalan, Prednisone | 477 | |
| Overall Study | STARTED | Carfilzomib, Melphalan, Prednisone | 478 | |
| Overall Study | Received Treatment | Bortezomib, Melphalan, Prednisone | 470 | |
| Overall Study | Received Treatment | Carfilzomib, Melphalan, Prednisone | 474 | |
| Overall Study | COMPLETED | Bortezomib, Melphalan, Prednisone | 290 | |
| Overall Study | COMPLETED | Carfilzomib, Melphalan, Prednisone | 280 | |
| Overall Study | NOT COMPLETED | Bortezomib, Melphalan, Prednisone | 187 | |
| Overall Study | NOT COMPLETED | Carfilzomib, Melphalan, Prednisone | 198 |
Source ClinicalTrials.gov
Adverse events690
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, Melphalan, Prednisone | 143 | 470 | |
| other | Anaemia | Blood and lymphatic system disorders | Carfilzomib, Melphalan, Prednisone | 168 | 474 | |
| other | Leukopenia | Blood and lymphatic system disorders | Bortezomib, Melphalan, Prednisone | 39 | 470 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carfilzomib, Melphalan, Prednisone | 34 | 474 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bortezomib, Melphalan, Prednisone | 121 | 470 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carfilzomib, Melphalan, Prednisone | 121 | 474 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bortezomib, Melphalan, Prednisone | 91 | 470 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carfilzomib, Melphalan, Prednisone | 84 | 474 | |
| other | Abdominal distension | Gastrointestinal disorders | Bortezomib, Melphalan, Prednisone | 27 | 470 | |
| other | Abdominal distension | Gastrointestinal disorders | Carfilzomib, Melphalan, Prednisone | 10 | 474 |
1 to 10 of 690Source ClinicalTrials.gov
See all 690 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bortezomib, Melphalan, Prednisone | ||
| Total, all-cause mortality | Carfilzomib, Melphalan, Prednisone | ||
| Total, other adverse events | Bortezomib, Melphalan, Prednisone | 437 | 470 |
| Total, other adverse events | Carfilzomib, Melphalan, Prednisone | 437 | 474 |
| Total, serious adverse events | Bortezomib, Melphalan, Prednisone | 198 | 470 |
| Total, serious adverse events | Carfilzomib, Melphalan, Prednisone | 235 | 474 |
Source ClinicalTrials.gov
Papers3
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, Melphalan, Prednisone vs Carfilzomib, Melphalan, Prednisone: 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/NCT01818752
GET https://conductscience.org/api/trials/v1/NCT01818752/results?page=2