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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003554-33 | EudraCT Number |
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Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.
This is a phase 3 multicenter, open-label, randomized study in participants with relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior therapies.
Participants receive the treatment determined by randomization for a maximum of approximately 5 years, up to 30 days prior to the final analysis data cutoff (DCO) date or until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). No crossover between the treatment arms is allowed.
This was an open-label study. However, the assessment of response and disease progression for the primary analysis was determined by an Independent Review Committee (IRC) in a blinded manner. Sensitivity analyses of response and disease progression were determined centrally by the sponsor using a validated computer algorithm (Onyx Response Computational Assessment [ORCA]) in a blinded manner.
Following progression or discontinuation of study drug(s), participants will have 1 follow-up visit (30 days [+3} after last dose of all study drug[s]). After disease progression, data on survival status and subsequent antimyeloma therapy will be gathered at long-term follow-up (LTFU) visits every 12 weeks (+/-2 weeks) until the Final Analysis DCO.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kd - Carfilzomib and Dexamethasone | Active Comparator | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. |
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| KdD - Carfilzomib, Dexamethasone and Daratumumab | Experimental | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg was further continued on Cycles 7+: day 1 only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Commercially available oral and IV formulas were obtained by investigative sites. Amgen supplied IV or PO dexa for some countries (Poland, Hungry, Romania, Bulgaria, Korea). Dosage modification rules applied based on participant age (participants > 75 years were given lower doses), dexa-related toxicities, and discontinuation of carfilzomib. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) | Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). The duration of PFS was right censored for participants who met any of the following conditions: 1. no baseline/post-baseline disease assessments; 2. started a new anti myeloma therapy before documentation of progressive disease or death; 3. progressive disease or death immediately after more than 70 days without disease assessment visit or; 4. alive without documentation of disease progression before the analysis trigger date (PA DCO); 5. lost to follow-up or withdrawn consent. | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only) | Overall response rate was defined as the percentage of participants in each treatment group who achieve partial response (PR) or better per the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) as their best response. Complete Response (CR): No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-component with urine M-component <100 mg/24 hours. Partial Response (PR): ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. 95% CIs for proportions were estimated using the Clopper-Pearson method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute | Boca Raton | Florida | 33486 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34046887 | Background | Quach H, Nooka A, Samoylova O, Venner CP, Kim K, Facon T, Spencer A, Usmani SZ, Grosicki S, Suzuki K, Delimpasi S, Weisel K, Obreja M, Zahlten-Kumeli A, Mateos MV. Carfilzomib, dexamethasone and daratumumab in relapsed or refractory multiple myeloma: results of the phase III study CANDOR by prior lines of therapy. Br J Haematol. 2021 Aug;194(4):784-788. doi: 10.1111/bjh.17541. Epub 2021 May 28. No abstract available. | |
| 34180331 |
| 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 were randomized in 1:2 ratio to arms KD vs KdD after being stratified by 1) International Staging System (ISS) stage (Stage 1-2 vs Stage 3) at screening, 2) prior proteasome inhibitor exposure (yes/no), 3) number of prior lines of therapy (1 vs ≥ 2), and 4) prior cluster differentiation antigen 38 (CD38) antibody therapy (yes/no).
This study was conducted at 102 centers. 569 participants were screened and 466 were enrolled. Primary analysis (PA) data cutoff (DCO): 14-Jul-2019. Final analysis (FA) DCO: 15-Apr-2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Kd - Carfilzomib and Dexamethasone | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 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 | Mar 17, 2021 | Apr 14, 2023 |
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| Daratumumab | Drug | Daratumumab was supplied as a concentrated solution for infusion in single-use vials. |
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| Carfilzomib | Drug | Carfilzomib for infusion was supplied as a lyophilized, sterile product in single-use vials. The lyophilized product was reconstituted with preservative-free sterile water for injection, the reconstituted solution contained carfilzomib 2 mg/mL. IV injections lasted approximately 30 minutes. Dose could be modified based on a >20% change in body weight or toxicity. |
|
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| From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
| Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee | MRD[-]CR at 12 months was defined as achievement of CR per IMWG-URC by IRC and MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) at the 12 months landmark (8 to 13 month window). | 12 Months (8- to 13-month window) |
| Overall Survival | Overall survival was defined as the time from randomization until death from any cause. Deaths collected via public source, after end of study were included. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive were censored at the date last known to be alive. | Up to 58 months after the first participant was enrolled (at FA DCO, a median of 40.29 weeks of treatment [any study drug] in the Kd group and 79.29 weeks of treatment [any study drug] in the KdD group; FA DCO was 15 Apr 2022) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events are defined as any adverse event with an onset after the administration of the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurs earlier. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal. Treatment-related adverse events are treatment-emergent adverse events considered related to at least one study drug by the investigator, including those with unknown relationship. | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks |
| Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only) | Duration of response (DOR) was defined as the time (in months) from first evidence of partial response (PR) or better per IMWG-URC by IRC to the earlier of disease progression or death due to any cause for participants with a best response of PR or better. For those who are alive and have not experienced disease progression at the time of data cutoff for analysis, duration of response was right-censored. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. | From Day 1 until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
| Kaplan-Meier Estimate for Time to Next Treatment (TTNT) | Time to next treatment was defined as the time (in months) from randomization to the initiation of subsequent non-protocol anti-cancer treatment for multiple myeloma. Time to next treatment for participants who do not start the subsequent treatment for multiple myeloma was censored at the date when the participant's information was last available. Medians of TTNT duration were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks |
| Kaplan-Meier Estimates for Time to Progression (TTP) as Assessed by the Independent Review Committee (PA DCO Only) | Time to progression was defined as the time (in months) from randomization to documented disease progression. Participants who did not have documented disease progression were censored at the date when data was last available. | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
| Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | Time to progression was defined as the time (in months) from randomization to documented disease progression. This outcome reports TTP as the percentage of participants who were event free (that is, they had not had disease progression) at the specified time frames. Independent Review Committee assessment for this outcome measure was not planned after the primary analysis. 95% CIs for event-free rates were estimated using the method by Kalbfleisch and Prentice (1980) with log-log transformation. | Randomization to Months 3, 6, 12, and 18 |
| Time to Overall Response as Assessed by the Independent Review Committee (PA DCO Only) | Time to overall response was defined as the time from randomization to the earliest date a response of partial response (PR) or better as per IMWG-URC is first achieved and subsequently confirmed for participants with a best response of PR or better. | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
| Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More | A measure of the persistence of the CR (includes strict CR) per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) for 12 months or more after achieving MRD[-]CR status. 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method. | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks |
| Percentage of Participants With a Complete Response (CR) as Assessed by the Independent Review Committee (PA DCO Only) | The percentage of participants in each treatment group who achieved stringent complete response (sCR) or CR per IMWG-URC, as assessed by the IRC, as their best response is presented. | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
| Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months | MRD[-] at 12-month was defined as achievement of MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) at the 12 months landmark (from 8 months to 13 months window). 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method. | 12 Months (8- to 13-month window) |
| Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. QLQ-C30 questionnaire was administered prior to dosing every 28 ± 7 days starting from cycle 1 day 1 through first follow-up visit (30 days [+3] after last dose of all study drugs). | Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO) |
| Emory University Winship Cancer Institute |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Chicago Medical Center - Multiple Myeloma Research Consortium | Chicago | Illinois | 60637-6613 | United States |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46845 | United States |
| Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi | 39401 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| New York Presbyterian Hospital, Weill Cornell Medical College | New York | New York | 10021 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Gabrail Cancer Center, LLC | Dover | Ohio | 44622 | United States |
| Charleston Oncology | Charleston | South Carolina | 29414 | United States |
| Baylor Charles A Sammons Cancer Center at Dallas | Dallas | Texas | 75246 | United States |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| St Vincents Hospital Sydney | St Leonards | New South Wales | 2065 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Womens Hospital | Herston | Queensland | 4029 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Epworth Healthcare | East Melbourne | Victoria | 3002 | Australia |
| St Vincents Hospital Melbourne | Fitzroy, VIC | Victoria | 3065 | Australia |
| Barwon Health, University Hospital Geelong | Geelong | Victoria | 3220 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Medizinische Universitaet Graz | Graz | 8036 | Austria |
| Landeskrankenhaus Salzburg | Salzburg | 5020 | Austria |
| Ziekenhuis Netwerk Antwerpen Stuivenberg | Antwerp | 2060 | Belgium |
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| Grand Hôpital de Charleroi | Charleroi | 6000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| 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 |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| Fakultni nemocnice Plzen | Pilsen | 304 60 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Centre Hospitalier Départemental les Oudairies | La Roche-sur-Yon | 85925 | France |
| Centre Hospitalier de Versailles - Hopital Andre Mignot | Le Chesnay | 78157 | France |
| Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez | Lille | 59037 | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | 44093 | France |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie | Poitiers | 86021 | France |
| Centre Hospitalier Universitaire de Nancy - Hopital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| General Hospital Evangelismos | Athens | 10676 | Greece |
| Alexandra Hospital | Athens | 11528 | Greece |
| General University Hospital of Patras Panagia i Voithia | Pátrai | 26504 | Greece |
| Theagenion Cancer Hospital of Thessaloniki | Thessaloniki | 54007 | Greece |
| Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz | Békéscsaba | 5600 | Hungary |
| Semmelweis Egyetem | Budapest | 1088 | Hungary |
| Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet | Budapest | 1097 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar | Szeged | 6725 | Hungary |
| 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 |
| Kyushu University Hospital | Fukuoka | Fukuoka | 812-8582 | Japan |
| Ogaki Municipal Hospital | Ogaki-shi | Gifu | 503-8502 | Japan |
| Gunma University Hospital | Maebashi | Gunma | 371-8511 | Japan |
| National Hospital Organization Shibukawa Medical Center | Shibukawa-shi | Gunma | 377-0280 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | Okayama-ken | 701-1192 | 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 |
| Tokushima Prefectural Central Hospital | Tokushima | Tokushima | 770-8539 | Japan |
| 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 |
| InterHem | Bialystok | 15-732 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie | Chorzów | 41-500 | Poland |
| Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli | Lublin | 20-090 | Poland |
| Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu | Poznan | 60-569 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | 02-776 | Poland |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | 50-367 | Poland |
| Policlinica de Diagnostic Rapid | Brasov | 500152 | Romania |
| Spitalul Clinic Colentina | Bucharest | 020125 | Romania |
| Fundeni Clinical Institute | Bucharest | 022328 | Romania |
| Coltea Clinical Hospital | Bucharest | 030171 | Romania |
| Bucharest Emergency University Hospital | Bucharest | 050098 | Romania |
| Profesor Dr Ion Chiricuta Institut of Oncology | Cluj-Napoca | 400124 | Romania |
| Spitalul Clinic Municipal Filantropia Craiova | Craiova | 200143 | Romania |
| SBHI of Nizhny Novgorod region Regional Clinical Hospital of Nizhny Novgorod na N A Semashko | Nizhny Novgorod | 603126 | Russia |
| SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov | Petrozavodsk | 185019 | Russia |
| State Budget Educational Institution of High Professional Skills Samara State Medical University | Samara | 443079 | Russia |
| Clinic of professional pathology and hematology | Saratov | 410028 | Russia |
| National Cancer Center | Goyang-si, Gyeonggi-do | 10408 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun, Jeollanam-do | 58128 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Hospital Clinico Universitario de Salamanca | Salamanca | Castilla León | 37007 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Cataluña | 08916 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Cataluña | 08036 | Spain |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Hacettepe Universitesi Tip Fakultesi | Ankara | 06100 | Turkey (Türkiye) |
| Ankara Universitesi Tip Fakultesi Cebeci Hastanesi | Ankara | 06590 | Turkey (Türkiye) |
| Ege University Faculty of Medicine | Izmir | 35040 | Turkey (Türkiye) |
| Ondokuz Mayis Universitesi Tip Fakultesi | Samsun | 55139 | Turkey (Türkiye) |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| University College London Hospital | London | NW1 2PG | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Background |
| Siegel D, Weisel K, Zahlten-Kumeli A, Medhekar R, Ding B, Leleu X. Health-related quality of life outcomes from the CANDOR study in patients with relapsed or refractory multiple myeloma. Leuk Lymphoma. 2021 Dec;62(12):3002-3010. doi: 10.1080/10428194.2021.1941927. Epub 2021 Jun 26. |
| 34410635 | Background | Suzuki K, Min CK, Kim K, Lee JJ, Shibayama H, Ko PS, Huang SY, Li SS, Ding B, Khurana M, Iida S. Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial. Int J Hematol. 2021 Dec;114(6):653-663. doi: 10.1007/s12185-021-03204-9. Epub 2021 Aug 19. |
| 34871550 | Background | Usmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Gavriatopoulou M, Oriol A, Rabin N, Nooka A, Qi M, Beksac M, Jakubowiak A, Ding B, Zahlten-Kumeli A, Yusuf A, Dimopoulos M. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study. Lancet Oncol. 2022 Jan;23(1):65-76. doi: 10.1016/S1470-2045(21)00579-9. Epub 2021 Dec 3. |
| 35608261 | Background | Landgren O, Weisel K, Rosinol L, Touzeau C, Turgut M, Hajek R, Mollee P, Kim JS, Shu N, Hu X, Li C, Usmani SZ. Subgroup analysis based on cytogenetic risk in patients with relapsed or refractory multiple myeloma in the CANDOR study. Br J Haematol. 2022 Sep;198(6):988-993. doi: 10.1111/bjh.18233. Epub 2022 May 24. |
| 32682484 | Background | Dimopoulos M, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Yang H, Klippel Z, Zahlten-Kumeli A, Usmani SZ. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. Lancet. 2020 Jul 18;396(10245):186-197. doi: 10.1016/S0140-6736(20)30734-0. |
| 33112184 | Background | Leleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28. |
| 37163358 | Background | Usmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Shu X, Li C, Dimopoulos M. Final analysis of carfilzomib, dexamethasone, and daratumumab vs carfilzomib and dexamethasone in the CANDOR study. Blood Adv. 2023 Jul 25;7(14):3739-3748. doi: 10.1182/bloodadvances.2023010026. |
| 40087058 | Background | Weisel K, Mateos MV, Landgren O, Leleu X, Quach H, Bennett L, Talpes M, Majer I, Patel S, Usmani SZ. Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma Treated With Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone: An Analysis of Patient-Reported Outcomes From the Phase 3 CANDOR Trial. Clin Lymphoma Myeloma Leuk. 2025 Aug;25(8):590-605. doi: 10.1016/j.clml.2025.02.005. Epub 2025 Feb 19. |
| FG001 | KdD - Carfilzomib, Dexamethasone and Daratumumab | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only. |
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| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Kd - Carfilzomib and Dexamethasone | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. |
| BG001 | KdD - Carfilzomib, Dexamethasone and Daratumumab | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Frailty Status as Assessed by Investigator | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead. | Count of Participants | Participants |
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| Time from Initial Diagnosis to Randomization | Data was not available for some participants. | Mean | Standard Deviation | months |
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| Risk Group as Determined by Fluorescent in situ Hybridization (FISH) | The high-risk group consists of the genetic subtypes t(4; 14), t(14; 16), or deletion17p. The standard-risk group consists of participants without t(4; 14), t(14; 16), and deletion 17p. The unknown risk group is participants with FISH result not done, failed or quantity was not sufficient. | Count of Participants | Participants |
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| Stratification Factor: International Staging System (ISS) Stage per IxRS | The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group (a lower stage indicates less progressed disease): Stage I: β2-microglobulin (β2M) < 3.5 mg/L, albumin >= 3.5 g/dL Stage II: β2M < 3.5 mg/L and albumin < 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin Stage III: β2M ≥ 5.5 mg/L. Higher stages indicate more advanced disease and/or poorer prognosis. Data is the ISS result assessed at the time of randomization using an interactive voice/web response system (IxRS). | Count of Participants | Participants |
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| Stratification Factor: Lines of Prior Treatment per IxRS | Number of participants grouped by total number of prior regimens. Data reported are randomization stratification values. | Count of Participants | Participants |
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| Stratification Factor: Prior Proteasome Inhibitor Treatment per IxRS | The number of participants with prior proteasome inhibitor treatment assessed at the time of randomization per the IxRS. Data reported are randomization stratification values. | Count of Participants | Participants |
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| Stratification Factor: Prior CD38 Antibody Therapy per IxRS | The number of participants with prior CD38 antibody therapy assessed at the time of randomization per the IxRS. Data reported are randomization stratification values. | Count of Participants | Participants |
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| Geographic Regions | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) as Assessed by the Independent Review Committee (PA DCO Only) | Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC). The duration of PFS was right censored for participants who met any of the following conditions: 1. no baseline/post-baseline disease assessments; 2. started a new anti myeloma therapy before documentation of progressive disease or death; 3. progressive disease or death immediately after more than 70 days without disease assessment visit or; 4. alive without documentation of disease progression before the analysis trigger date (PA DCO); 5. lost to follow-up or withdrawn consent. | Intent to Treat Population | Posted | Count of Participants | Participants | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
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| Secondary | Overall Response (OR) as Assessed by the Independent Review Committee (PA DCO Only) | Overall response rate was defined as the percentage of participants in each treatment group who achieve partial response (PR) or better per the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) as their best response. Complete Response (CR): No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-component with urine M-component <100 mg/24 hours. Partial Response (PR): ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline. 95% CIs for proportions were estimated using the Clopper-Pearson method. | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
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| Secondary | Minimal Residual Disease Negative Complete Response Rate (MRD[-]CR) at 12 Months as Assessed by the Independent Review Committee | MRD[-]CR at 12 months was defined as achievement of CR per IMWG-URC by IRC and MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) at the 12 months landmark (8 to 13 month window). | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 Months (8- to 13-month window) |
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| Secondary | Overall Survival | Overall survival was defined as the time from randomization until death from any cause. Deaths collected via public source, after end of study were included. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive were censored at the date last known to be alive. | Intent to Treat Population | Posted | Median | 95% Confidence Interval | months | Up to 58 months after the first participant was enrolled (at FA DCO, a median of 40.29 weeks of treatment [any study drug] in the Kd group and 79.29 weeks of treatment [any study drug] in the KdD group; FA DCO was 15 Apr 2022) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse events are defined as any adverse event with an onset after the administration of the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurs earlier. The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal. Treatment-related adverse events are treatment-emergent adverse events considered related to at least one study drug by the investigator, including those with unknown relationship. | Safety Population | Posted | Count of Participants | Participants | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks |
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| Secondary | Kaplan-Meier Estimate for Duration of Response (DOR) (PA DCO Only) | Duration of response (DOR) was defined as the time (in months) from first evidence of partial response (PR) or better per IMWG-URC by IRC to the earlier of disease progression or death due to any cause for participants with a best response of PR or better. For those who are alive and have not experienced disease progression at the time of data cutoff for analysis, duration of response was right-censored. Medians were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. | Participants who responded in the Intent to Treat Population | Posted | Median | 95% Confidence Interval | months | From Day 1 until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
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| Secondary | Kaplan-Meier Estimate for Time to Next Treatment (TTNT) | Time to next treatment was defined as the time (in months) from randomization to the initiation of subsequent non-protocol anti-cancer treatment for multiple myeloma. Time to next treatment for participants who do not start the subsequent treatment for multiple myeloma was censored at the date when the participant's information was last available. Medians of TTNT duration were estimated using the Kaplan-Meier method. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. | Intent to Treat Population | Posted | Median | 95% Confidence Interval | months | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks |
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| Secondary | Kaplan-Meier Estimates for Time to Progression (TTP) as Assessed by the Independent Review Committee (PA DCO Only) | Time to progression was defined as the time (in months) from randomization to documented disease progression. Participants who did not have documented disease progression were censored at the date when data was last available. | Intent to Treat Population | Posted | Median | 95% Confidence Interval | months | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
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| Secondary | Time to Progression (TTP): Percentage of Participants Who Had Not Had Disease Progression as Assessed by the Independent Review Committee at Months 3, 6, 12, and 18 (PA DCO Only) | Time to progression was defined as the time (in months) from randomization to documented disease progression. This outcome reports TTP as the percentage of participants who were event free (that is, they had not had disease progression) at the specified time frames. Independent Review Committee assessment for this outcome measure was not planned after the primary analysis. 95% CIs for event-free rates were estimated using the method by Kalbfleisch and Prentice (1980) with log-log transformation. | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Months 3, 6, 12, and 18 |
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| Secondary | Time to Overall Response as Assessed by the Independent Review Committee (PA DCO Only) | Time to overall response was defined as the time from randomization to the earliest date a response of partial response (PR) or better as per IMWG-URC is first achieved and subsequently confirmed for participants with a best response of PR or better. | Participants who responded in the Intent to Treat Population | Posted | Mean | Standard Deviation | months | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
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| Secondary | Percentage of Participants Who Achieved and Maintained a Minimal Residual Disease Negative Complete Response (MRD[-]CR) for 12 Months or More | A measure of the persistence of the CR (includes strict CR) per International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) for 12 months or more after achieving MRD[-]CR status. 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method. | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of participants | PA DCO: the longest treatment duration as of the PA DCO was 102.3 weeks; FA DCO: the longest treatment duration as of the FA DCO was 236.3 weeks |
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| Secondary | Percentage of Participants With a Complete Response (CR) as Assessed by the Independent Review Committee (PA DCO Only) | The percentage of participants in each treatment group who achieved stringent complete response (sCR) or CR per IMWG-URC, as assessed by the IRC, as their best response is presented. | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the PA DCO date of 14 July 2019; the longest treatment duration as of the DCO was 102.3 weeks |
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| Secondary | Percentage of Participants Who Achieved Minimal Residual Disease Negative (MRD[-]) Status as Assessed by Next Generation Sequencing at 12 Months | MRD[-] at 12-month was defined as achievement of MRD[-] status as assessed by next-generation sequencing (NGS; at a 10^-5 level) at the 12 months landmark (from 8 months to 13 months window). 95% confidence intervals (CIs) for proportions were estimated using the Clopper-Pearson method. | Intent to Treat Population | Posted | Number | 95% Confidence Interval | percentage of participants | 12 Months (8- to 13-month window) |
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| Secondary | Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose | Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. QLQ-C30 questionnaire was administered prior to dosing every 28 ± 7 days starting from cycle 1 day 1 through first follow-up visit (30 days [+3] after last dose of all study drugs). | Intent to Treat Population | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO) |
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Treatment-emergent adverse events - any adverse events with an onset after the administration of the first dose of any study treatment and within the end of the study or 30 days of the last dose of any study treatment, whichever occurred earlier. The longest treatment duration as of the FA DCO was 236.3 weeks.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
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 | Kd - Carfilzomib and Dexamethasone | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. | 80 | 154 | 80 | 153 | 137 | 153 |
| EG001 | KdD - Carfilzomib, Dexamethasone and Daratumumab | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only. | 148 | 312 | 211 | 308 | 295 | 308 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Plasmacytosis | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Arteriospasm coronary | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Extrasystoles | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Thyroid mass | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diverticular perforation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Unevaluable event | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Hepatitis toxic | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
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| Acinetobacter infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Campylobacter infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Catheter site abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Gastroenteritis salmonella | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Meningitis pneumococcal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Picornavirus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombophlebitis septic | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Venous injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoglobin abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Medical observation | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stupor | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypomania | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial enlargement | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Microvascular coronary artery disease | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Herpes dermatitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Dural tear | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 25.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 25.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotonic urinary bladder | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dialysis hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | 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_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2019 | Jul 13, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C556306 | daratumumab |
| C524865 | carfilzomib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
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| OG001 | KdD - Carfilzomib, Dexamethasone and Daratumumab | Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only. |
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Carfilzomib was administered intravenously (IV) at 20 mg/m^2 in Cycle 1: days 1 and 2; at 56 mg/m^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16. Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days. Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only. |
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