Trial · NCT04191616
Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet
NCT04191616, Phase 2, Completed, Amgen; results first posted 2023-11-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet. Trials, record NCT04191616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04191616
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet
- NCT number
- NCT04191616
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- Carfilzomib, Dexamethasone, Pomalidomide
- First posted
- 2019-12-10
- Last updated
- 2025-09-04
- Other registries' IDs
- eudract:2019-001169-34
- Results first posted
- 2023-11-08
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) | From day 1 cycle 1 until the primary analysis (PA) data cutoff (DCO); the mean duration of KPd treatment as of the DCO was 42.0 weeks | Overall response was defined as the best overall confirmed response of: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. Assessment was by IRC per International Myeloma Working Group Uniform Response Criteria (IMWG-URC). The 90% confidence intervals were estimated using the Clopper-Pearson method (1994). |
| Secondary | Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC | Day 1 cycle 1 to month 12 (8 to 13 month window) | The MRD\[-\]CR rate was defined as the percentage of participants who reached MRD\[-\]CR at the 12 month landmark (8- to 13-month window). MRD\[-\]CR was defined as the achievement of CR (including sCR or better) per IMWG-URC by IRC assessment and MRD\[-\] status at a sensitivity of 10\^-5 using next-generation sequencing based method in the bone marrow. The 90% CIs were estimated using the Clopper-Pearson method (1994). |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From the first dose of any study treatment until the end of study or 30 days after the last dose of any study treatment, whichever occured earlier; Median (min, max) was 8.5 (1.0, 46.6) months | TEAEs were defined as events with onset on or after the administration of the first dose of any study treatment and within the end of study, or 30 days after the last dose of any study treatment, whichever one was earlier, excluding events reported after end of study date. |
| Secondary | Number of Participants Achieving MRD[-] Response | From day 1 cycle 1 until the end of study (EOS); the mean duration of KPd treatment as of the EOS was 55.3 weeks | MRD\[-\] response was defined as achievement of MRD\[-\] status using next generation sequencing (NGS) based method in the bone marrow at any time. |
| Secondary | Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC | Day 1 cycle 1 to month 12 (8 to 13 month window) | MRD\[-\]CR at the 12 months landmark was defined as achievement of CR (including sCR or better) per IMWG-URC by IRC and MRD\[-\] status at a sensitivity of 10\^-5 using NGS based method in the bone marrow at the 12 months landmark (from 8 months to 13 months window). Maintaining MRD\[-\]CR for at least 12 months (- 4 weeks) was considered as sustained. |
| Secondary | Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC | Day 1 cycle 1 to month 26 (19 to 26 month window) | Sustained MRD\[-\]CR at 24 months included participants that maintained MRD\[-\]CR for 12 months or more after achieving MRD\[-\]CR status at 12 months. |
| Secondary | Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | Disease response and progression were determined using IMWG-URC. Durations were calculated for responders. Medians and percentiles were estimated using the Kaplan-Meier method. 90% CIs for medians and percentiles were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. |
| Secondary | Time to Response as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | Durations were calculated for responders. Time to response was defined as the time from start of any study treatment date to the earliest date when confirmed sCR, CR, very good partial response (VGPR), or partial response (PR) was first achieved. |
| Secondary | Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | PFS was defined as time from start of treatment until progression or death from any cause. Medians and percentiles were estimated using the Kaplan-Meier method by Klein and Moeschberger (1997). 90% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. |
| Secondary | Kaplan-Meier Estimate of Overall Survival (OS) | From day 1 cycle 1 until the EOS; the mean duration of KPd treatment was 55.3 weeks. | OS was defined as the time from the start of treatment until death from any cause. Medians and percentiles were estimated using the Kaplan-Meier method. 90% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) | From day 1 cycle 1 until the primary analysis (PA) data cutoff (DCO); the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC | Day 1 cycle 1 to month 12 (8 to 13 month window) | The safety analysis set included all participants who received at least 1 dose of carfilzomib. The analysis was pre-specified until PA DCO only. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From the first dose of any study treatment until the end of study or 30 days after the last dose of any study treatment, whichever occured earlier; Median (min, max) was 8.5 (1.0, 46.6) months | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving MRD[-] Response | From day 1 cycle 1 until the end of study (EOS); the mean duration of KPd treatment as of the EOS was 55.3 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC | Day 1 cycle 1 to month 12 (8 to 13 month window) | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC | Day 1 cycle 1 to month 26 (19 to 26 month window) | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. Only participants who achieved a partial response or better were included in the analysis. | months | MEDIAN |
| SECONDARY | Time to Response as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. Only participants who achieved a partial response or better were included in the analysis. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC | From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Overall Survival (OS) | From day 1 cycle 1 until the EOS; the mean duration of KPd treatment was 55.3 weeks. | The safety analysis set included all participants who received at least 1 dose of carfilzomib. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 57.7 | 90% Confidence Interval 45.4 to 69.3 | percentage of participants | |
| Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 3.8 | 90% Confidence Interval 0.7 to 11.6 | percentage of participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 50 | Participants | ||
| Number of Participants Achieving MRD[-] Response | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 5 | Participants | ||
| Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 0 | Participants | ||
| Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 0 | Participants | ||
| Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 20.3 | 90% Confidence Interval 9.2 to NA | months | |
| Time to Response as Assessed by the IRC | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 1.0 | Full Range 1 to 2 | months | |
| Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 11.1 | 90% Confidence Interval 6.5 to NA | months | |
| Kaplan-Meier Estimate of Overall Survival (OS) | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 17.6 | 90% Confidence Interval 11.2 to 23.5 | months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-assignment Period | STARTED | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 54 | |
| Pre-assignment Period | COMPLETED | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 52 | |
| Pre-assignment Period | NOT COMPLETED | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 2 | |
| Treatment Period | STARTED | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 52 | |
| Treatment Period | Received Carfilzomib | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 52 | |
| Treatment Period | Received Pomalidomide | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 52 | |
| Treatment Period | Received Dexamethasone | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 52 | |
| Treatment Period | COMPLETED | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 0 | |
| Treatment Period | NOT COMPLETED | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 52 |
Source ClinicalTrials.gov
Adverse events61
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 | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 16 | 52 | |
| other | Leukopenia | Blood and lymphatic system disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 3 | 52 | |
| other | Neutropenia | Blood and lymphatic system disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 17 | 52 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 16 | 52 | |
| other | Diarrhoea | Gastrointestinal disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 9 | 52 | |
| other | Nausea | Gastrointestinal disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 7 | 52 | |
| other | Vomiting | Gastrointestinal disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 5 | 52 | |
| other | Asthenia | General disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 9 | 52 | |
| other | Fatigue | General disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 12 | 52 | |
| other | Oedema peripheral | General disorders | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 11 | 52 |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 37 | 54 |
| Total, other adverse events | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 48 | 52 |
| Total, serious adverse events | Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 22 | 52 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38497533 | BACKGROUND |
Source PubMed
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04191616
GET https://conductscience.org/api/trials/v1/NCT04191616/events?page=2