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NCT04191616: SELECT

Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet

Completed Phase 2 Results posted Last updated 4 September 2025
What this trial tests

Phase 2 trial testing Carfilzomib in Relapsed or Refractory Multiple Myeloma in 54 participants. Completed in 1 October 2024.

Timeline
6 August 2020
Primary endpoint
30 November 2022
1 October 2024

Quick facts

Lead sponsorAmgen
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment54
Start date6 August 2020
Primary completion30 November 2022
Estimated completion1 October 2024
Sites46 locations across Denmark, France, Italy, Greece, Estonia, Germany, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 99, any sex, with Relapsed or Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) Primary · 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 pe

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)57.745.4 – 69.3
Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC Secondary · 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).

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)3.80.7 – 11.6
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Secondary · 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.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)50
Number of Participants Achieving MRD[-] Response Secondary · 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.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)5
Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC Secondary · 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.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)0
Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC Secondary · 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.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)0
Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC Secondary · 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.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)20.39.2 – NA
Time to Response as Assessed by the IRC Secondary · 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.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)1.01 – 2
Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC Secondary · 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.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)11.16.5 – NA
Kaplan-Meier Estimate of Overall Survival (OS) Secondary · 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.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)17.611.2 – 23.5
Number of Participants With Best Overall Confirmed Response of CR or Better as Assessed by the IRC Secondary · From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks

The number of safety analysis set participants whose best overall response was sCR or CR per IMWG-URC over the duration of the study.

GroupValue95% CI
Carfilzomib With Pomalidomide and Dexamethasone (KPd)3

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality: from enrollment until the end of study or death date, whichever occurs later; Median (min, max) time on study was 15.2 (0.0, 47.0) months. Adverse events: 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 occurs earlier; Median (min, max) was 8.5 (1.0, 46.6) months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Carfilzomib With Pomalidomide and Dexamethasone (KPd)
Serious: 22/52 (42%)
Deaths: 37/54

Serious adverse events (28 terms)

ReactionSystemCarfilzomib With Pomalidom…
Acute kidney injuryRenal and urinary disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
NeutropeniaBlood and lymphatic system disorders
COVID-19Infections and infestations
COVID-19 pneumoniaInfections and infestations
InfectionInfections and infestations
PneumoniaInfections and infestations
SepsisInfections and infestations
Cerebrovascular accidentNervous system disorders
LeukopeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
Cardiac arrestCardiac disorders
Cardiac failureCardiac disorders
Cardiac failure chronicCardiac disorders
Left ventricular failureCardiac disorders
PyrexiaGeneral disorders
Clostridium difficile infectionInfections and infestations
Cytomegalovirus infectionInfections and infestations
Lower respiratory tract infectionInfections and infestations
Femoral neck fractureInjury, poisoning and procedural complications
Bone painMusculoskeletal and connective tissue disorders
OsteitisMusculoskeletal and connective tissue disorders
Confusional statePsychiatric disorders
Renal disorderRenal and urinary disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
Other adverse events (33 terms — click to expand)

ReactionSystemCarfilzomib With Pomalidom…
NeutropeniaBlood and lymphatic system disorders
AnaemiaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
FatigueGeneral disorders
Oedema peripheralGeneral disorders
DiarrhoeaGastrointestinal disorders
AstheniaGeneral disorders
PyrexiaGeneral disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
RashSkin and subcutaneous tissue disorders
HypertensionVascular disorders
NauseaGastrointestinal disorders
Muscle spasmsMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
COVID-19Infections and infestations
Upper respiratory tract infectionInfections and infestations
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
VomitingGastrointestinal disorders
HyperglycaemiaMetabolism and nutrition disorders
ParaesthesiaNervous system disorders
Respiratory tract infectionInfections and infestations
Bone painMusculoskeletal and connective tissue disorders
LeukopeniaBlood and lymphatic system disorders
Platelet count decreasedInvestigations
DehydrationMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
SyncopeNervous system disorders
InsomniaPsychiatric disorders
Acute kidney injuryRenal and urinary disorders
Dyspnoea exertionalRespiratory, thoracic and mediastinal disorders
Lower respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
Pain in extremityMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Acute kidney injury, Respiratory failure, Neutropenia, COVID-19, COVID-19 pneumonia, Infection, Pneumonia, Sepsis.

Data from ClinicalTrials.gov NCT04191616 adverse events section.

Sponsor's own description

A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Minimal Residual Disease in Multiple Myeloma: Current Landscape and Future Applications With Immunotherapeutic Approaches.
    Kostopoulos IV, Ntanasis-Stathopoulos I, Gavriatopoulou M, Tsitsilonis OE, et al · · 2020 · cited 42× · PMID 32537439 · DOI 10.3389/fonc.2020.00860
  2. The role of carfilzomib in relapsed/refractory multiple myeloma.
    Yee AJ. · · 2021 · cited 18× · PMID 34163580 · DOI 10.1177/20406207211019612
  3. Ikaros Proteins in Tumor: Current Perspectives and New Developments.
    Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440
  4. Pomalidomide- and dexamethasone-based regimens in the treatment of refractory/relapsed multiple myeloma.
    Fotiou D, Gavriatopoulou M, Terpos E, Dimopoulos MA. · · 2022 · cited 11× · PMID 35585966 · DOI 10.1177/20406207221090089
  5. An open-label phase 2 study treating patients with first or second relapse of multiple myeloma with carfilzomib, pomalidomide, and dexamethasone (KPd): SELECT study.
    Perrot A, Delimpasi S, Spanoudakis E, Frølund U, et al · · 2024 · cited 10× · PMID 38497533 · DOI 10.1080/10428194.2024.2322030
  6. Phase 1/2 study of carfilzomib, pomalidomide, and dexamethasone with and without daratumumab in relapsed multiple myeloma.
    Derman BA, Zonder J, Reece D, Cole C, et al · · 2023 · cited 6× · PMID 36763537 · DOI 10.1182/bloodadvances.2022008866
  7. Targeting the proteasome in cancer therapy: development and future opportunities in natural products.
    Zhao X, Liu S, Zeng X, Liao Y, et al · · 2026 · PMID 42158938 · DOI 10.3389/fphar.2026.1806787

Verify or expand the search:

Other trials of Carfilzomib

Trials testing the same drug.

Other recruiting trials for Relapsed or Refractory Multiple Myeloma

Currently open trials in the same condition.

Other Amgen trials

Trials by the same sponsor.

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