Relapsed or Refractory Multiple MyelomaPhase 2SELECTNCT04191616
Study of Early Relapsed, Lenalidomide-refractory Subjects Eligible for Carfilzomib Triplet
A Phase 2 study testing Carfilzomib, Dexamethasone and Pomalidomide in people with Relapsed or Refractory Multiple Myeloma, run by Amgen at 46 sites in 8 countries.
Trial summary
A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Carfilzomib, Dexamethasone and Pomalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 46 sitesin 8 countries
- Study dates
- 6 Aug 2020to 1 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent prior to initiation of any study specific activities or procedures.
- Male or female subjects age ≥ 18 years
- First or second relapse of multiple myeloma by IMWG criteria (subjects refractory to the most recent line of therapy, excluding carfilzomib, are eligible)
- Refractory to lenalidamide
- Measurable disease with at least 1 of the following assessed within 28 days prior to enrollment:
- IgG multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
Show all 12Show fewer
- IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL
- urine M-protein ≥ 200 mg per 24 hours
- in subjects without measurable serum or urine M-protein, serum-free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
- Must have at least a PR to at least 1 line of prior therapy
- Prior therapy with proteasome inhibitors is allowed. Subjects receiving prior carfilzomib therapy must have achieved at least a PR, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval from their last dose of carfilzomib
- ECOG PS of 0 to 2
Who cannot join
- Primary refractory multiple myeloma
- Waldenström macroglobulinemia
- Multiple myeloma of IgM subtype
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia ( greater than 2.0 × 109/L circulating plasma cells by differential). If automated differential shows ≥ 20% of other cells, obtain manual differential to identify other cells.
- Primary amyloidosis (patients with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met)
Show all 10Show fewer
- Previous diagnosis of amyloidosis associated with myeloma
- Myelodysplastic syndrome
- Toxicity requiring discontinuation of lenalidomide therapy
- Prior treatment with pomalidomide
Trial locations and contacts
46 sites in 8 countries.
46 sites in 8 countries
United States13 sites
Texas Oncology - Austin Midtown
Austin, Texas, 78705
United States Oncology Regulatory Affairs Corporate Office
Austin, Texas, 78705
US Oncology Research Investigational Products Center
Austin, Texas, 78705
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, 60415
Oncology Hematology Care Incorporated
Cincinnati, Ohio, 45236
Baylor Charles A Sammons Cancer Center at Dallas
Dallas, Texas, 75246
Rocky Mountain Cancer Centers Denver Midtown
Denver, Colorado, 80218
Texas Oncology, Fort Worth
Fort Worth, Texas, 76104
Yale Cancer Center
New Haven, Connecticut, 06510
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Minnesota Oncology Hematology PA
Saint Paul, Minnesota, 55102
Texas Oncology- Tyler
Tyler, Texas, 75702
France7 sites
CHU Grenoble Alpes
Grenoble, 38043
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille, 59037
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque
Pessac, 33604
Centre Hospitalier de Saint Quentin
Saint-Quentin, 02321
Clinique Sainte Anne
Strasbourg, 67000
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059
Greece7 sites
University General Hospital of Evros-Alexandroupolis District
Alexandroupoli, 68100
General Hospital Evangelismos
Athens, 10676
Alexandra Hospital
Athens, 11528
University Hospital of Ioannina
Ioannina, 45500
General University Hospital of Patras Panagia i Voithia
Pátrai, 26504
Theagenion Cancer Hospital of Thessaloniki
Thessaloniki, 54007
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki, 57010
Italy5 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, 60126
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce, 73100
Policlinico Universitario Agostino Gemelli
Roma, 00168
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
Torino, 10126
Spain5 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Clinico Universitario de Salamanca
Salamanca, Castille and León, 37007
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
Denmark4 sites
Aalborg Universitetshospital
Aalborg, 9000
Aarhus Universitetshospital
Aarhus N, 8200
Sjaellands Universitetshospital
Roskilde, 4000
Vejle Sygehus
Vejle, 7100
Germany4 sites
Klinikum Chemnitz gGmbH
Chemnitz, 09113
Asklepios Klinik Altona
Hamburg, 22763
Universitätsklinikum Münster
Münster, 48149
Universitatsklinikum Tubingen
Tübingen, 72076
About this study
Official title: An Open-label, Phase 2 Study Treating Subjects With First or Second Relapse of Multiple Myeloma With Carfilzomib, Pomalidomide, and Dexamethasone (KPd)
A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone
Read the detailed description
An Open-label, Phase 2 Study Treating Subjects with First or Second Relapse of Multiple Myeloma with Carfilzomib, Pomalidomide, and Dexamethasone (KPd)
This trial is designed to estimate the efficacy of a carfilzomib-based triplet in first or second relapse of multiple myeloma for subjects refractory to lenalidomide. The study is an open-label, phase 2 trial. Subjects may receive treatment until progression.
Myeloma disease status will be monitored locally for response and progression per International Myeloma Working Group (IMWG) criteria (Kumar et al, 2016) every 28 ± 7 days from cycle 1 day 1 until confirmed progressive disease (PD), death, lost to follow-up, or withdrawal of full consent (whichever occurs first), regardless of cycle duration, dose delays or treatment discontinuation. Subjects with a suspected complete response (CR) or better will have a bone marrow for minimal residual disease (MRD) assessment at 12 and 24 months (± 4 weeks) from start of treatment (unless a MRD assessment was performed within 4 months before planned assessment).
Subjects who end study drug(s) without confirmed PD are required to complete disease response assessments and report new anti-myeloma treatment every 28 ± 7 days until first subsequent anti-myeloma treatment, death, lost to follow-up, withdrawal of full consent, confirmed PD, or end of study, whichever occurs first. Subjects who discontinue treatment and either start new anti-myeloma treatment or have PD will enter long-term follow-up every 12 weeks until death or end of study.
Approximately one-third of subjects enrolled in the study will be in first relapse and two-thirds in second relapse.
This study will enroll adults ≥ 18 years of age with first or second relapse multiple myeloma.
Eligible subjects will have relapsed multiple myeloma after receiving 1 or 2 prior lines of therapy.
Subjects must be refractory to lenalidomide. Subjects may not have received prior pomalidomide. Prior exposure to a proteasome inhibitor is allowed. Subjects previously exposed to carfilzomib must have responded with at least a partial response to carfilzomib, must not have discontinued carfilzomib due to toxicity, may not have relapsed while receiving or within 60 days of the last dose of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval since their last dose of carfilzomib.
Subjects must have measurable disease per IMWG consensus criteria, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2, and at least partial response to 1 line of therapy.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Carfilzomib, Dexamethasone, Pomalidomide
- Keywords
- Multiple Myeloma, RRMM, Open-label, First Relapse Multiple Myeloma, Second Relapse Multiple Myeloma, Refractory to Lenalidomide, Triplicate Treatment Regimen, Dexamethasone, Carfilzomib, Pomalidomide
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
Also called Kyprolis
Carfilzomib will be administered intravenously over 30 ± 5 minutes, on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression. A dose of 20 mg/m^2 will be administered on day 1 of cycle 1. All subsequent doses will be 56 mg/m^2. The frequency of carfilzomib administration will be reduced to day 1 and 15 per cycle starting with cycle 13 and continued until progression or end of study.
DexamethasoneDrug
Also called Decadron, Ozurdex, DexPak 6, 10, 13 Day, ReadySHarp, LoCort, Maxidex
Dexamethasone will be administered at least 30 minutes, but no more than 4 hours prior to carfilzomib on days of carfilzomib administration. Dexamethasone will be administered at a dose of 40 mg on days 1, 8, 15, and 22 of each 28-day cycle up to progression during cycles 1 to 12. Dexamethasone will be administered at a dose of 20 mg on days 1 and 15 of each 28-day cycle up to progression during cycles 13 onward. For subjects more than or equal to 75 years of age, the dose will be 20 mg during cycles 1 through 12 and 10 mg from cycles 13 onward.
PomalidomideDrug
Also called Pomalyst
Pomalidomide dose will be 4 mg per day orally on days 1 to 21 of each cycle until progression.
| Study group | Role | What they receive |
|---|---|---|
| Carfilzomib combined with pomalidomide and dexamethasone | Experimental | Carfilzomib, pomalidomide, and dexamethasone (KPd) Receives: Drug: Carfilzomib; Drug: Dexamethasone; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC)
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).
Measured: 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
Secondary outcomes (10)
Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC
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).
Measured: Day 1 cycle 1 to month 12 (8 to 13 month window)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Measured: 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
Number of Participants Achieving MRD[-] Response
MRD[-] response was defined as achievement of MRD[-] status using next generation sequencing (NGS) based method in the bone marrow at any time.
Measured: 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
Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC
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.
Measured: Day 1 cycle 1 to month 12 (8 to 13 month window)
Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC
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.
Measured: Day 1 cycle 1 to month 26 (19 to 26 month window)
Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC
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.
Measured: From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
Time to Response as Assessed by the IRC
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.
Measured: From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC
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.
Measured: From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
Kaplan-Meier Estimate of Overall Survival (OS)
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.
Measured: From day 1 cycle 1 until the EOS; the mean duration of KPd treatment was 55.3 weeks.
Number of Participants With Best Overall Confirmed Response of CR or Better as Assessed by the IRC
The number of safety analysis set participants whose best overall response was sCR or CR per IMWG-URC over the duration of the study.
Measured: From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start6 Aug 2020
- Primary completion30 Nov 2022
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191616
- Sponsor's protocol ID
- 20180117
- Other IDs
- 2019-001169-34, 2019
- Acronym
- SELECT
- Status last verified
- Aug 2025
- First submitted
- 22 Nov 2019
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
Perrot A, Delimpasi S, Spanoudakis E, Frolund U, Belotti A, Oriol A, Moreau P, McFadden I, Xia Q, Arora M, Dimopoulos MA. An open-label phase 2 study treating patients with first or second relapse of multiple myeloma with carfilzomib, pomalidomide, and dexamethasone (KPd): SELECT study. Leuk Lymphoma. 2024 Jun;65(6):833-842. doi: 10.1080/10428194.2024.2322030. Epub 2024 Mar 18.
PubMed 38497533
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 2 Study Treating Subjects With First or Second Relapse of Multiple Myeloma With Carfilzomib, Pomalidomide, and Dexamethasone (KPd)
- ClinicalTrials.gov ID
- NCT04191616
- Acronym / sponsor ID
- SELECT / 20180117
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- Multiple Myeloma, RRMM, Open-label, First Relapse Multiple Myeloma, Second Relapse Multiple Myeloma, Refractory to Lenalidomide, Triplicate Treatment Regimen, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Posted 8 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone
Detailed description
An Open-label, Phase 2 Study Treating Subjects with First or Second Relapse of Multiple Myeloma with Carfilzomib, Pomalidomide, and Dexamethasone (KPd)
This trial is designed to estimate the efficacy of a carfilzomib-based triplet in first or second relapse of multiple myeloma for subjects refractory to lenalidomide. The study is an open-label, phase 2 trial. Subjects may receive treatment until progression.
Myeloma disease status will be monitored locally for response and progression per International Myeloma Working Group (IMWG) criteria (Kumar et al, 2016) every 28 ± 7 days from cycle 1 day 1 until confirmed progressive disease (PD), death, lost to follow-up, or withdrawal of full consent (whichever occurs first), regardless of cycle duration, dose delays or treatment discontinuation. Subjects with a suspected complete response (CR) or better will have a bone marrow for minimal residual disease (MRD) assessment at 12 and 24 months (± 4 weeks) from start of treatment (unless a MRD assessment was performed within 4 months before planned assessment).
Subjects who end study drug(s) without confirmed PD are required to complete disease response assessments and report new anti-myeloma treatment every 28 ± 7 days until first subsequent anti-myeloma treatment, death, lost to follow-up, withdrawal of full consent, confirmed PD, or end of study, whichever occurs first. Subjects who discontinue treatment and either start new anti-myeloma treatment or have PD will enter long-term follow-up every 12 weeks until death or end of study.
Approximately one-third of subjects enrolled in the study will be in first relapse and two-thirds in second relapse.
This study will enroll adults ≥ 18 years of age with first or second relapse multiple myeloma.
Eligible subjects will have relapsed multiple myeloma after receiving 1 or 2 prior lines of therapy.
Subjects must be refractory to lenalidomide. Subjects may not have received prior pomalidomide. Prior exposure to a proteasome inhibitor is allowed. Subjects previously exposed to carfilzomib must have responded with at least a partial response to carfilzomib, must not have discontinued carfilzomib due to toxicity, may not have relapsed while receiving or within 60 days of the last dose of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval since their last dose of carfilzomib.
Subjects must have measurable disease per IMWG consensus criteria, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2, and at least partial response to 1 line of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carfilzomib combined with pomalidomide and dexamethasone | Experimental | Drug: Carfilzomib, Drug: Dexamethasone, Drug: PomalidomideCarfilzomib, pomalidomide, and dexamethasone (KPd) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject has provided informed consent prior to initiation of any study specific activities or procedures.
- Male or female subjects age ≥ 18 years
- First or second relapse of multiple myeloma by IMWG criteria (subjects refractory to the most recent line of therapy, excluding carfilzomib, are eligible)
- Refractory to lenalidamide
- Measurable disease with at least 1 of the following assessed within 28 days prior to enrollment:
Key exclusion criteria (10 listed)
- Primary refractory multiple myeloma
- Waldenström macroglobulinemia
- Multiple myeloma of IgM subtype
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia ( greater than 2.0 × 109/L circulating plasma cells by differential). If automated differential shows ≥ 20% of other cells, obtain manual differential to identify other cells.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarfilzomibAlso: KyprolisCarfilzomib will be administered intravenously over 30 ± 5 minutes, on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression. A dose of 20 mg/m^2 will be administered on day 1 of cycle 1. All subsequent doses will be 56 mg/m^2. The frequency of carfilzomib administration will be reduced to day 1 and 15 per cycle starting with cycle 13 and continued until progression or end of study. | Drug | Carfilzomib combined with pomalidomide and dexamethasone |
| DexamethasoneAlso: Decadron, Ozurdex, DexPak 6, 10, 13 Day, ReadySHarp, LoCort, MaxidexDexamethasone will be administered at least 30 minutes, but no more than 4 hours prior to carfilzomib on days of carfilzomib administration. Dexamethasone will be administered at a dose of 40 mg on days 1, 8, 15, and 22 of each 28-day cycle up to progression during cycles 1 to 12. Dexamethasone will be administered at a dose of 20 mg on days 1 and 15 of each 28-day cycle up to progression during cycles 13 onward. For subjects more than or equal to 75 years of age, the dose will be 20 mg during cycles 1 through 12 and 10 mg from cycles 13 onward. | Drug | Carfilzomib combined with pomalidomide and dexamethasone |
| PomalidomideAlso: PomalystPomalidomide dose will be 4 mg per day orally on days 1 to 21 of each cycle until progression. | Drug | Carfilzomib combined with pomalidomide and dexamethasone |
Primary outcome
Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC)
Time frame: 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).
10 secondary outcomes
Percentage of Participants With a Minimal Residual Disease Negative Complete Response (MRD[-]CR) as Assessed by the IRC
Time frame: Day 1 cycle 1 to month 12 (8 to 13 month window)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 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
Number of Participants Achieving MRD[-] Response
Time frame: 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
Number of Participants With Sustained MRD[-]CR for at Least 12 Months as Assessed by the IRC
Time frame: Day 1 cycle 1 to month 12 (8 to 13 month window)
Number of Participants With Sustained MRD[-]CR at Month 24 as Assessed by the IRC
Time frame: Day 1 cycle 1 to month 26 (19 to 26 month window)
Kaplan-Meier Estimate of Duration of Response as Assessed by the IRC
Time frame: From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
Time to Response as Assessed by the IRC
Time frame: From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
Kaplan-Meier Estimate of Progression Free Survival (PFS) as Assessed by the IRC
Time frame: From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
Kaplan-Meier Estimate of Overall Survival (OS)
Time frame: From day 1 cycle 1 until the EOS; the mean duration of KPd treatment was 55.3 weeks.
Number of Participants With Best Overall Confirmed Response of CR or Better as Assessed by the IRC
Time frame: From day 1 cycle 1 until the PA DCO; the mean duration of KPd treatment as of the DCO was 42.0 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38497533Perrot A, Delimpasi S, Spanoudakis E, Frolund U, Belotti A, Oriol A, Moreau P, McFadden I, Xia Q, Arora M, Dimopoulos MA. An open-label phase 2 study treating patients with first or second relapse of multiple myeloma with carfilzomib, pomalidomide, and dexamethasone (KPd): SELECT study. Leuk Lymphoma. 2024 Jun;65(6):833-842. doi: 10.1080/10428194.2024.2322030. Epub 2024 Mar 18.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Relapsed or Refractory Multiple Myeloma
Active, not recruitingPhase 3
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
RecruitingPhase 2
Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carfilzomib, Dexamethasone and Pomalidomide in people with Relapsed or Refractory Multiple Myeloma, run by Amgen at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, France, Greece, Italy, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) As Assessed by the Independent Review Committee (IRC) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.