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Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carfilzomib once-weekly | Active Comparator | Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using once-weekly carfilzomib 56 mg/m2 |
|
| Carfilzomib twice-weekly | Active Comparator | Carfilzomib, lenalidomide, dexamethasone (KRd) regimen using twice-weekly carfilzomib 27 mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib | Drug | Once weekly IV over 30 minutes on day 1, 8 and 15 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 day 1 and 56 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC) | ORR 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) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to < 200 mg/24-hours. The ORR 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method. | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimate of Progression-free Survival (PFS) Rate at 12 Months | PFS rate was defined as the percentage of participants without disease progression or death due to any cause at 12 months. The PFS rate at 12 months was estimated using the Kaplan-Meier method by Klein and Moeschberger (1997). 95% CIs were estimated using the method by Kalbfleisch and Prentice (1980). PFS data was censored for participants who met any one of the following: 1. no baseline/no post-baseline disease assessments; 2. starting new anti-myeloma therapy before documentation of progressive disease (PD) or death; 3. PD or death immediately after more than 1 consecutively missed disease assessment visit (PD or death immediately after > 63 days without disease assessment visit); 4. alive without documentation of PD; 5. lost to follow-up or withdrawn consent. |
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Inclusion Criteria:
Multiple myeloma with documented relapse or progression after most recent myeloma treatment. Subjects refractory to the most recent line of therapy are eligible, unless last treatment contained proteasome inhibitor (PI) or lenalidomide and dexamethasone. Refractory is defined as disease that is nonresponsive or progresses within 60 days of last therapy.
Subjects must have at least PR to at least 1 line of prior therapy.
Subjects must have received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation maintenance therapy will be considered as 1 line of therapy).
Prior therapy with a PI or the combination of lenalidomide and dexamethasone are allowed if the patient had at least a PR to the most recent treatment with a PI or lenalidomide and dexamethasone, neither PI or lenalidomide and dexamethasone containing treatment were ceased due to toxicity, the patient has not relapsed within 60 days of discontinuation of the PI or lenalidomide and dexamethasone containing treatment. A history of prior neuropathy is permitted if this was not grade 3, grade 4 or grade 2 with pain and if not resolved within the 14 days before enrollment, is less than or equal to grade 2 without pain. Patients are permitted to have received single agent lenalidomide as maintenance therapy within 60 days of enrollment.
Previous treatment with a lenalidomide and dexamethasone containing regimen is allowed, as long as the subject did not progress during the first 3 months after initiating lenalidomide and dexamethasone containing therapy.
Measurable disease with at least 1 of the following assessed within 21 days prior to randomization:
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 ≤ 2
Other inclusion criteria may apply
Exclusion Criteria:
Waldenström macroglobulinemia.
Multiple myeloma of Immunoglobulin M (IgM) subtype.
Plasma cell leukemia (> 2.0 × 10^9 /L circulating plasma cells by standard differential).
Uncontrolled hypertension, defined as a subject whose blood pressure is greater than or equal to 160 mmHg systolic or greater than or equal to 100 mmHg diastolic when taken in accordance with the European Society of Hypertension/European Society of Cardiology 2018 guidelines (Section 12.10; Williams et al, 2018).
Active congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization.
Calculated or measured creatinine clearance < 30 mL/min (calculation must be based on the Cockcroft and Gault formula) within 28 days prior to randomization.
Other exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert A Moss Oncology | Fountain Valley | California | 92708 | United States | ||
| Rocky Mountain Cancer Centers Denver Midtown |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39024542 | Derived | Dimopoulos MA, Coriu D, Delimpasi S, Spicka I, Upchurch T, Fang B, Talpur R, Faber E, Beksac M, Leleu X. A.R.R.O.W.2: once- vs twice-weekly carfilzomib, lenalidomide, and dexamethasone in relapsed/refractory multiple myeloma. Blood Adv. 2024 Oct 8;8(19):5012-5021. doi: 10.1182/bloodadvances.2024013101. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Participants with relapsed or refractory multiple myeloma were randomized in a 1:1 ratio to receive once-weekly or twice-weekly carfilzomib. Randomization was stratified by original International Staging System (ISS) stage at the time of study entry (stage 1 or 2 versus stage 3), prior lenalidomide treatment (yes versus no), prior proteasome inhibitor treatment (yes versus no), and prior anti-CD38 exposure (yes versus no).
Participants were enrolled at 80 study centers in Europe, Japan, and the United States, and participated from 08 May 2019 to 31 March 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Twice-weekly Kyprolis (Carfilzomib) + Lenalidomide + Dexamethsone (KRd) 20/27 mg/m^2 | Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m^2 on Days 1 and 2 of Cycle 1 and 27 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2021 | Mar 25, 2024 |
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|
| Carfilzomib | Drug | Twice weekly IV over 10 minutes on day 1, 2, 8, 9, 15 and 16 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 27 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent. |
|
| Lenalidomide | Drug | Once daily orally 25 mg days 1 to 21 of each cycle. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent |
|
| Dexamethasone | Drug | Once daily orally or by IV 40 mg days 1, 8 and 15 of each cycle. Also day 22 of cycles 1 to 9. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent |
|
| 12 months |
| Percentage of Participants Who Reported Convenience as Measured by the Patient-reported Convenience With Carfilzomib-dosing Schedule Question | Patient-reported convenience was measured by the Patient-reported Convenience with Carfilzomib-dosing Schedule Question. The items in the questionnaire were categorized as 'Convenient', which included responses of 'Very Convenient' and 'Convenient', and 'Inconvenient' which included responses of 'Inconvenient' and 'Very Inconvenient'. The 95% CIs were estimated using the Clopper-Pearson method. | Day 28 of Cycle 4 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were AEs starting on or after the first dose of any study drug, and up to 30 days of the last dose of any study drug, excluding AEs reported after End of Study date. | Cycle 1 Day 1 up to end of Cycle 12 + 30 days, where each cycle was 28 days; median treatment duration (any study treatment) was 47.00 weeks in the twice-weekly KRd group and 47.14 weeks in the once-weekly KRd group |
| Time to Response (TTR) | TTR was defined as the time from randomization to the earliest date when confirmed sCR, CR, VGPR, or PR per IMWG-URC was first achieved. | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
| Kaplan-Meier Estimate of Duration of Response (DOR) | For participants who achieved a PR or better, i.e., sCR, CR, VGPR, or PR per IMWG-URC, the DOR was defined as the time from the earliest date when a PR or better was first achieved, and subsequently confirmed, to the earliest date of confirmed PD or death due to any cause. Median DOR was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. For those alive and who had not experienced PD by analysis time, DOR was censored for participants who met any one of the following: 1. no baseline/no post-baseline disease assessments; 2. starting new anti-myeloma therapy before documentation of PD or death; 3. PD or death immediately after more than 1 consecutively missed disease assessment visit (PD or death immediately after > 63 days without disease assessment visit); 4. alive without documentation of PD; 5. lost to follow-up or withdrawn consent. | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
| Kaplan-Meier Estimate of Time to Progression (TTP) | TTP was defined as the duration from randomization for the first documented disease progression per IMWG-UCR. Median TTP was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. TTP was censored for participants who had no confirmed PD at the last non non-evaluable (non-NE), post-baseline disease assessment or the earlier of the following, where applicable: 1. the last non-NE, post-baseline disease assessment prior to start of a new anti-myeloma treatment, or 2. the last non-NE, post-baseline assessment followed > 63 days later by disease progression; otherwise, at randomization. | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
| Kaplan-Meier Estimate of Overall Survival (OS) | OS was defined as the time from randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive or lost to follow-up or withdrawn consent from study by the analysis time were censored at the date on which the participant was last known to be alive. | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
| Percentage of Participants Who Achieved Minimal Residual Disease Negative Complete Response (MRD[-]CR) by Independent Review Committee (IRC) Per IMWG-URC | MRD[-]CR was defined as achievement of CR or better by IRC per IMWG-URC and achievement of MRD negativity as assessed by next generation sequencing method at a 10^-5 threshold over the duration of the study. The 95% CIs for percentages were estimated using the Clopper-Pearson method. | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
| Percentage of Participants With Minimal Residual Disease Negativity (MRD[-]) by IRC Per IMWG-URC at 12 Months | The percentage of participants with achievement of MRD[-] at 12 months (± 4 weeks) from randomization, as assessed by next generation sequencing method at a 10^-5 threshold. MRD negativity results from BM samples obtained at 8 to 13 months from randomization and prior to new anti-myeloma therapy or disease progression were considered in the calculation. The 95% CIs for percentages were estimated using the Clopper-Pearson method. | Cycle 1 Day 1 up to 12 months (cycle = 28 days) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ)-Core 30 (C30) Physical Functioning Scale | The QLQ-C30 physical function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the physical functioning score score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning. | Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose) |
| Change From Baseline in EORTC QLQ-C30 Role Functioning Scale | The QLQ-C30 role function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the role functioning score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning. | Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose) |
| Patient-reported Treatment Satisfaction as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ) | The CTSQ measures treatment satisfaction in individuals with cancer and includes a domain for satisfaction with therapy. The satisfaction with therapy scores ranges from 0 to 100 points, with 100 points indicating greatest satisfaction. Analysis was based on ANCOVA model. The dependent variable of the models were the scale scores measured at each visit. The model included effects of intercept, scale score measured at cycle 2 day 1 visit, treatment arm, and randomization stratification factors. | Cycle 5 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose) |
| Denver |
| Colorado |
| 80218 |
| United States |
| Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut | Plainville | Connecticut | 06062 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| New York Oncology Hematology, PC | Albany | New York | 12208 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | United States |
| Texas Oncology-Denton | Denton | Texas | 76201 | United States |
| US Oncology Research Investigational Products Center | Fort Worth | Texas | 76177 | United States |
| Oncology Consultants PA | Houston | Texas | 77030 | United States |
| Texas Oncology | San Antonio | Texas | 78229 | United States |
| United States Oncology Regulatory Affairs Corporate Office | The Woodlands | Texas | 77380 | United States |
| Universitaetsklinikum Salzburg | Salzburg | 5020 | Austria |
| University Multiprofile Hospital for Active Treatment Sveti Georgi EAD | Plovdiv | 4002 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD | Sofia | 1431 | Bulgaria |
| Specialized Hospital for Active Treatment of Hematology Diseases EAD | Sofia | 1756 | Bulgaria |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Helsingin Yliopistollinen Keskussairaala | Helsinki | 00290 | Finland |
| Oulun Yliopistollinen Sairaala | Oulu | 90220 | Finland |
| Turun Yliopistollinen Keskussairaala | Turku | 20521 | Finland |
| Centre Hospitalier Universitaire de Nantes | Nantes | 44000 | France |
| Centre Hospitalier Universitaire Archet 2 | Nice | 06202 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital Pitie-Salpetriere | Paris | 75013 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie | Poitiers | 86021 | France |
| Centre Hospitalier Universitaire de Rennes | Rennes | 35033 | France |
| Institut de Cancerologie Strasbourg | Strasbourg | 67033 | France |
| Institut Universitaire du Cancer Toulouse Oncopole | Toulouse | 31059 | France |
| Centre Hospitalier Universitaire de Nancy - Hopital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Universitatsklinikum Koln | Cologne | 50924 | Germany |
| Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden | Dresden | 01307 | Germany |
| Universitatsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Johannes Gutenberg Universitaet Mainz | Mainz | 55131 | Germany |
| University Hospital of Alexandroupolis | Alexandroupoli | 68100 | Greece |
| General Hospital Evangelismos | Athens | 10676 | Greece |
| Agios Savvas Anticancer Hospital | Athens | 115 22 | Greece |
| 251 General Airforce Hospital | Athens | 11525 | Greece |
| Alexandra Hospital | Athens | 11528 | Greece |
| Metropolitan Hospital | Athens | 18547 | Greece |
| General University Hospital of Patras Panagia i Voithia | Pátrai | 26504 | Greece |
| Theagenion Cancer Hospital of Thessaloniki | Thessaloniki | 54007 | Greece |
| General Hospital of Thessaloniki Georgios Papanikolaou | Thessaloniki | 57010 | Greece |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Toyohashi Municipal Hospital | Toyohashi | Aichi-ken | 441-8570 | Japan |
| Tesshokai Kameda General Hospital | Kamogawa-shi | Chiba | 296-8602 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Fukuoka | 811-1395 | Japan |
| Ogaki Municipal Hospital | Ogaki-shi | Gifu | 503-8502 | Japan |
| National Hospital Organization Shibukawa Medical Center | Shibukawa-shi | Gunma | 377-0280 | Japan |
| Japanese Red Cross Society Himeji Hospital | Himeji-shi | Hyōgo | 670-8540 | Japan |
| Hyogo College of Medicine Hospital | Nishinomiya-shi | Hyōgo | 663-8501 | Japan |
| Hitachi Ltd Hitachi General Hospital | Hitachi-shi | Ibaraki | 317-0077 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
| National Hospital Organization Sendai Medical Center | Sendai | Miyagi | 983-8520 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | Okayama-ken | 701-1192 | Japan |
| Japanese Red Cross Osaka Hospital | Osaka | Osaka | 543-8555 | Japan |
| Kindai University Hospital | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Osaka University Hospital | Suita-shi | Osaka | 565-0871 | Japan |
| Saitama Medical Center | Kawagoe-shi | Saitama | 350-8550 | Japan |
| Tochigi Cancer Center | Utsunomiya | Tochigi | 320-0834 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| Japanese Red Cross Medical Center | Shibuya-ku | Tokyo | 150-8935 | Japan |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution | Kaunas | 50009 | Lithuania |
| Vilnius University Hospital Santaros Clinic Public Institution | Vilnius | 08661 | Lithuania |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Gelre Ziekenhuizen | Apeldoorn | 7334 DZ | Netherlands |
| Spaarne Gasthuis | Hoofddorp | 2134 TM | Netherlands |
| Spitalul Clinic Colentina | Bucharest | 020125 | Romania |
| Fundeni Clinical Institute | Bucharest | 022328 | Romania |
| Institutul Clinic Fundeni | Bucharest | 022328 | Romania |
| Spitalul Clinic Coltea | Bucharest | 030171 | Romania |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | 050098 | Romania |
| Institutul Oncologic Prof Dr Ion Chiricuta | Cluj-Napoca | 400015 | Romania |
| Institutul Regional de Oncologie Iasi | Iași | 700483 | Romania |
| Spitalul Clinic Dr Gavril Curteanu Oradea | Oradea | 410469 | Romania |
| Spitalul Clinic Judetean de Urgenta Sibiu | Sibiu | 550245 | Romania |
| Spitalul Clinic Municipal de Urgenta Timisoara | Timișoara | 300079 | Romania |
| Regional Clinical Hospital | Krasnoyarsk | 660022 | Russia |
| Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department | Moscow | 123182 | Russia |
| SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department | Moscow | 125284 | Russia |
| SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov | Petrozavodsk | 185019 | Russia |
| Federal centre of heart, blood and endocrinology Almazova | Saint Petersburg | 197341 | Russia |
| State Budget Educational Institution of High Professional Skills Samara State Medical University | Samara | 443079 | Russia |
| Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda | Bratislava | 851 07 | Slovakia |
| Hospital Universitari Son Espases | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | Castille and León | 37007 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Catalonia | 08916 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Falu Lasarett | Falun | 791 82 | Sweden |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 413 45 | Sweden |
| Hallands Sjukhus Halmstad | Halmstad | 301 85 | Sweden |
| Sunderby Sjukhus | Luleå | 971 80 | Sweden |
| Skanes Universitetssjukhus | Lund | 221 85 | Sweden |
| Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi | Ankara | 06560 | Turkey (Türkiye) |
| Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi | Ankara | 06590 | Turkey (Türkiye) |
| Istanbul Universitesi Istanbul Tip Fakultesi | Istanbul | 34093 | Turkey (Türkiye) |
| Bagcilar Medipol Mega Universite Hastanesi | Istanbul | 34214 | Turkey (Türkiye) |
| Istanbul Florence Nightingale Hastanesi | Istanbul | 34387 | Turkey (Türkiye) |
| Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi | Izmir | 35340 | Turkey (Türkiye) |
| Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi | Kayseri | 38039 | Turkey (Türkiye) |
| FG001 | Once-weekly KRd 20/56 mg/m^2 | Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m^2 on Day 1 of Cycle 1 and 56 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. |
| Received Carfilzomib |
|
| Completed 12 Cycles Carfilzomib |
|
| Received Lenalidomide |
|
| Received Dexamethasone |
|
| Safety Population | Participants were analyzed according to the treatment arm corresponding to the actual treatment received. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Twice-weekly KRd 20/27 mg/m^2 | Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m^2 on Days 1 and 2 of Cycle 1 and 27 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. |
| BG001 | Once-weekly KRd 20/56 mg/m^2 | Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m^2 on Day 1 of Cycle 1 and 56 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Original ISS Stage at Study Entry | ISS stage classification at study entry per interactive voice/web response system for randomization. Stage 1: serum beta-2 microglobulin < 3.5 mg/L and serum albumin ≥ 3.5 g/dL; Stage 2: serum beta-2 microglobulin < 3.5 mg/L and serum albumin < 3.5 g/dL or serum beta-2 microglobulin 3.5 - < 5.5 mg/L irrespective of the serum albumin; Stage 3: serum beta-2 microglobulin ≥ 5.5 mg/L. | Count of Participants | Participants |
| |||||||||||||||
| Prior Lenalidomide Treatment | Count of Participants | Participants |
| ||||||||||||||||
| Prior Proteasome Inhibitor Treatment | Count of Participants | Participants |
| ||||||||||||||||
| Prior Anti-CD38 Treatment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Response Rate (ORR) Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC) | ORR 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) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to < 200 mg/24-hours. The ORR 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
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| Secondary | Kaplan-Meier Estimate of Progression-free Survival (PFS) Rate at 12 Months | PFS rate was defined as the percentage of participants without disease progression or death due to any cause at 12 months. The PFS rate at 12 months was estimated using the Kaplan-Meier method by Klein and Moeschberger (1997). 95% CIs were estimated using the method by Kalbfleisch and Prentice (1980). PFS data was censored for participants who met any one of the following: 1. no baseline/no post-baseline disease assessments; 2. starting new anti-myeloma therapy before documentation of progressive disease (PD) or death; 3. PD or death immediately after more than 1 consecutively missed disease assessment visit (PD or death immediately after > 63 days without disease assessment visit); 4. alive without documentation of PD; 5. lost to follow-up or withdrawn consent. | The ITT analysis set included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
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| Secondary | Percentage of Participants Who Reported Convenience as Measured by the Patient-reported Convenience With Carfilzomib-dosing Schedule Question | Patient-reported convenience was measured by the Patient-reported Convenience with Carfilzomib-dosing Schedule Question. The items in the questionnaire were categorized as 'Convenient', which included responses of 'Very Convenient' and 'Convenient', and 'Inconvenient' which included responses of 'Inconvenient' and 'Very Inconvenient'. The 95% CIs were estimated using the Clopper-Pearson method. | The ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 of Cycle 4 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were AEs starting on or after the first dose of any study drug, and up to 30 days of the last dose of any study drug, excluding AEs reported after End of Study date. | The safety population included all randomized participants who received at least 1 dose of any study treatment (carfilzomib, lenalidomide, or dexamethasone). Participants were analyzed according to the treatment arm corresponding to the actual treatment received. | Posted | Count of Participants | Participants | Cycle 1 Day 1 up to end of Cycle 12 + 30 days, where each cycle was 28 days; median treatment duration (any study treatment) was 47.00 weeks in the twice-weekly KRd group and 47.14 weeks in the once-weekly KRd group |
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| Secondary | Time to Response (TTR) | TTR was defined as the time from randomization to the earliest date when confirmed sCR, CR, VGPR, or PR per IMWG-URC was first achieved. | The ITT population included all randomized participants. Data is presented for participants in the ITT population who achieved a confirmed response of PR or better. | Posted | Median | Full Range | months | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
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| Secondary | Kaplan-Meier Estimate of Duration of Response (DOR) | For participants who achieved a PR or better, i.e., sCR, CR, VGPR, or PR per IMWG-URC, the DOR was defined as the time from the earliest date when a PR or better was first achieved, and subsequently confirmed, to the earliest date of confirmed PD or death due to any cause. Median DOR was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. For those alive and who had not experienced PD by analysis time, DOR was censored for participants who met any one of the following: 1. no baseline/no post-baseline disease assessments; 2. starting new anti-myeloma therapy before documentation of PD or death; 3. PD or death immediately after more than 1 consecutively missed disease assessment visit (PD or death immediately after > 63 days without disease assessment visit); 4. alive without documentation of PD; 5. lost to follow-up or withdrawn consent. | The ITT population included all randomized participants. Data is presented for participants in the ITT population who achieved a confirmed response of PR or better. | Posted | Median | Full Range | months | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
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| Secondary | Kaplan-Meier Estimate of Time to Progression (TTP) | TTP was defined as the duration from randomization for the first documented disease progression per IMWG-UCR. Median TTP was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. TTP was censored for participants who had no confirmed PD at the last non non-evaluable (non-NE), post-baseline disease assessment or the earlier of the following, where applicable: 1. the last non-NE, post-baseline disease assessment prior to start of a new anti-myeloma treatment, or 2. the last non-NE, post-baseline assessment followed > 63 days later by disease progression; otherwise, at randomization. | The ITT population included all randomized participants. | Posted | Median | Full Range | months | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
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| Secondary | Kaplan-Meier Estimate of Overall Survival (OS) | OS was defined as the time from randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive or lost to follow-up or withdrawn consent from study by the analysis time were censored at the date on which the participant was last known to be alive. | The ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
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| Secondary | Percentage of Participants Who Achieved Minimal Residual Disease Negative Complete Response (MRD[-]CR) by Independent Review Committee (IRC) Per IMWG-URC | MRD[-]CR was defined as achievement of CR or better by IRC per IMWG-URC and achievement of MRD negativity as assessed by next generation sequencing method at a 10^-5 threshold over the duration of the study. The 95% CIs for percentages were estimated using the Clopper-Pearson method. | The ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks. |
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| Secondary | Percentage of Participants With Minimal Residual Disease Negativity (MRD[-]) by IRC Per IMWG-URC at 12 Months | The percentage of participants with achievement of MRD[-] at 12 months (± 4 weeks) from randomization, as assessed by next generation sequencing method at a 10^-5 threshold. MRD negativity results from BM samples obtained at 8 to 13 months from randomization and prior to new anti-myeloma therapy or disease progression were considered in the calculation. The 95% CIs for percentages were estimated using the Clopper-Pearson method. | The ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 Day 1 up to 12 months (cycle = 28 days) |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ)-Core 30 (C30) Physical Functioning Scale | The QLQ-C30 physical function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the physical functioning score score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning. | The ITT population included all randomized participants. Participants with data available at each time point are presented. All participants in the overall number of participants analyzed contributed to the data in the endpoint. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose) |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Role Functioning Scale | The QLQ-C30 role function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the role functioning score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning. | The ITT population included all randomized participants. Participants with data available at each time point are presented. All participants in the overall number of participants analyzed contributed to the data in the endpoint. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose) |
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| Secondary | Patient-reported Treatment Satisfaction as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ) | The CTSQ measures treatment satisfaction in individuals with cancer and includes a domain for satisfaction with therapy. The satisfaction with therapy scores ranges from 0 to 100 points, with 100 points indicating greatest satisfaction. Analysis was based on ANCOVA model. The dependent variable of the models were the scale scores measured at each visit. The model included effects of intercept, scale score measured at cycle 2 day 1 visit, treatment arm, and randomization stratification factors. | The ITT population included all randomized participants. Participants with data available at each time point are presented. | Posted | Least Squares Mean | Standard Error | Score on a scale | Cycle 5 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose) |
|
All-cause mortality was collected from enrollment to End of Study; median study duration was 12.0 months. AEs were collected from first dose of study drug to last dose of study drug + 30 days; median treatment duration (any study treatment) was 11.8 months.
All-cause mortality was collected for all participants enrolled/randomized in the study and is presented according to the randomized treatment arm. Serious AEs and other AEs were collected for all participants in the safety population who received at least one dose of study drug. Participants in the safety population were analyzed according to the treatment arm corresponding to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Twice-weekly KRd 20/27 mg/m^2 | Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m^2 on Days 1 and 2 of Cycle 1 and 27 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. | 22 | 226 | 75 | 231 | 190 | 231 |
| EG001 | Once-weekly KRd 20/56 mg/m^2 | Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m^2 on Day 1 of Cycle 1 and 56 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. | 26 | 228 | 84 | 223 | 182 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinobronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 26.0 | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Amplified musculoskeletal pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cryoglobulinaemia | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2023 | Mar 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| D019046 | Bone Marrow Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C524865 | carfilzomib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Stage 3 |
|
| No |
|
| No |
|
| No |
|
Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m^2 on Day 1 of Cycle 1 and 56 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. |
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Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m^2 on Day 1 of Cycle 1 and 56 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
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| OG001 | Once-weekly KRd 20/56 mg/m^2 | Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m^2 on Day 1 of Cycle 1 and 56 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. |
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|
Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m^2 on Day 1 of Cycle 1 and 56 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles. |
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Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m^2 on Day 1 of Cycle 1 and 56 mg/m^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
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