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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414MMY3007 | Other Identifier | Janssen Research and Development, LLC | |
| 2014-002272-88 | EudraCT Number |
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The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).
The study consists of 3 phases: Screening Phase (within 21 days prior to randomization), Treatment Phase (Cycle 1 Day 1 to discontinuation of all study treatment), and Follow-up Phase (from discontinuation of all study treatment up to death, lost to follow up, withdrawal of consent, or the study ends, whichever occurs first). Treatment phase will include 2 treatments (Treatment A: participants will receive Velcade MelphalanPrednisone (VMP) alone and Treatment B: participants will receive daratumumab in combination with VMP).Two interim analyses are planned. The first will be to evaluate safety after a total of approximately 100 participants have been treated for at least 2 cycles or discontinued the study treatment. The second will be to evaluate cumulative interim safety and efficacy data, and will be performed when approximately 216 PFS events have been accumulated. The final OS analysis will occur when approximately 382 deaths have occurred. Efficacy will be primarily measured by comparison of PFS between the two treatment arms. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A (VMP Alone) | Active Comparator | Participants will receive velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 , orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. |
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| Treatment Arm B (D-VMP) | Experimental | Participants will receive velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 mg/kg as IV infusion, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. On days when daratumumab is given, dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute, and prednisone 60 mg/m2 once daily will be given on Days 2-4. Following amendment 7, participants will have the option to switch to daratumumab subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velcade | Drug | Participants will receive velcade 1.3 mg/m^2, as subcutaneous injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS: duration from date of randomization to progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum M-component (absolute increase >=0.5 grams per deciliter [g/dL]); Urine M-component (absolute increase >=200 milligrams [mg]/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow Plasma cells (PC) percentage (%) (absolute % >=10%); Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. | From randomization (Day -3) up to 2.4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (>=) 50 percentage (%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California City | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42085642 | Derived | Bahlis N, Facon T, San-Miguel J, Usmani SZ, Dimopoulos MA, Moreau P, Zweegman S, Perrot A, Manier S, Chari A, Raje N, Orlowski RZ, Goldschmidt H, Basu S, Hulin C, Weisel K, Mohty M, Leleu X, Plesner T, Jakubowiak A, Cook G, Quach H, Venner CP, Cavo M, Ngo M, Bolyard K, Carson R, Borgsten F, Mateos MV, Kumar SK. Infections in patients receiving daratumumab for newly diagnosed multiple myeloma: a pooled analysis of MAIA and ALCYONE. Blood Adv. 2026 Jul 14;10(13):4541-4550. doi: 10.1182/bloodadvances.2025019323. | |
| 40220771 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Velcade, Melphalan and Prednisone (VMP) | Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab. |
| 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 | Feb 14, 2018 | Nov 21, 2018 |
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| Melphalan | Drug | Participants will receive melphalan 9 mg/m^2, orally, once daily on Days 1 to 4 of each cycle up to Cycle 9. |
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| Prednisone | Drug | Participants will receive prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. |
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| Daratumumab IV | Drug | Participants will receive daratumumab 16 mg/kg as intravenous infusion, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study . |
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| Dexamethasone | Drug | Participants administered with dexamethasone 20 mg IV or PO is given 1 hour or less prior to daratumumab administration as pre medication and prednisone substitute. |
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| Daratumumab SC | Drug | Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or until the end of study. Following amendment 7, participants can switch from daratumumab IV to daratumumab SC. |
|
| From randomization (Day -3) up to 2.4 years |
| Percentage of Participants With Very Good Partial Response (VGPR) or Better | VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. | From randomization (Day -3) up to 2.4 years |
| Percentage of Participants With Complete Response (CR) or Better | CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. | From randomization (Day -3) up to 2.4 years |
| Percentage of Participants With Stringent Complete Response (sCR) | sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; <5% plasma cells (PCs) in bone marrow. | From randomization (Day -3) up to 2.4 years |
| Percentage of Participants With Negative Minimal Residual Disease (MRD) | The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). | From randomization (Day -3) up to 8.3 years |
| Overall Survival (OS) | Overall Survival (OS) was measured from the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. | From randomization (Day -3) up to 8.3 years |
| Progression Free Survival on Next Line of Therapy (PFS2) | Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment. | From randomization (Day -3) up to 8.3 years |
| Time to Disease Progression (TTP) | TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase >=0.5 g/dL); Urine M-component (absolute increase >=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % >=10%); Bone marrow PC %: absolute % >10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. | From randomization (Day -3) up to 2.4 years |
| Time to Response | Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required. | From randomization (Day -3) up to 2.4 years |
| Duration of Response (DOR) | DOR: participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase>=0.5 g/dL); Urine M-component (absolute increase>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%>=10%); Bone marrow PC's %: absolute%>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | From first documentation of response up to 2.4 years |
| Time to Next Treatment (TNT) | Time to next treatment is defined as the time from randomization to the start of the next-line treatment. Kaplan-Meier method was used for the analysis. | From randomization (Day -3) up to 8.3 years |
| Percentage of Participants With Best M-protein Response | Percentage of participants with Best M- protein response of 100% reduction and >=90% to < 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC). | Up to 2.4 years |
| Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score | The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values for function and GHS scale indicated deterioration in quality of life or functioning and positive values indicate improvement. | Baseline (Day -24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48 |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Global Health Scale | The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values for function and GHS scale indicated deterioration in quality of life or functioning and positive values indicate improvement. | Baseline (Day -24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48 |
| Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS) | EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. | Baseline (Day- 24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48 |
| Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score | EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm. | Baseline (Day -24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48 |
| Corona |
| California |
| United States |
| Fountain Valley | California | United States |
| Los Angeles | California | United States |
| Hialeah | Florida | United States |
| Orange Park | Florida | United States |
| Chicago | Illinois | United States |
| Springfield | Missouri | United States |
| Cleveland | Ohio | United States |
| Fredericksburg | Virginia | United States |
| Buenos Aires | Argentina |
| Ciudad Autonoma Buenos Aires | Argentina |
| Córdoba | Argentina |
| Santa Fe | Argentina |
| Adelaide | Australia |
| Bendigo | Australia |
| Camperdown | Australia |
| Geelong | Australia |
| Gosford | Australia |
| Greenslopes | Australia |
| Hobart | Australia |
| North Adelaide | Australia |
| Parkville | Australia |
| Antwerp | Belgium |
| Brussels | Belgium |
| Charleroi | Belgium |
| Ghent | Belgium |
| Kortrijk | Belgium |
| Roeselare | Belgium |
| Turnhout | Belgium |
| Yvoir | Belgium |
| Barretos | Brazil |
| Cuiaba - Mount | Brazil |
| Fortaleza | Brazil |
| Goiânia | Brazil |
| Natal | Brazil |
| Porto Alegre | Brazil |
| Ribeirão Preto | Brazil |
| Rio de Janeiro | Brazil |
| São Paulo | Brazil |
| Pleven | Bulgaria |
| Plovdiv | Bulgaria |
| Sofia | Bulgaria |
| Varna | Bulgaria |
| Vratsa | Bulgaria |
| Zadar | Croatia |
| Zagreb | Croatia |
| Brno | Czechia |
| Hradec Králové | Czechia |
| Olomouc | Czechia |
| Ostrava-Poruba | Czechia |
| Prague | Czechia |
| Tbilisi | Georgia |
| Berlin | Germany |
| Dortmund | Germany |
| Karlsruhe | Germany |
| Potsdam | Germany |
| Saarbrücken | Germany |
| Stuttgart | Germany |
| Würzburg | Germany |
| Athens | Greece |
| Athens Attica | Greece |
| Pátrai | Greece |
| Thessaloniki | Greece |
| Budapest | Hungary |
| Debrecen | Hungary |
| Kaposvár | Hungary |
| Pécs | Hungary |
| Chiba | Japan |
| Hitachi | Japan |
| Kanazawa | Japan |
| Kawasaki | Japan |
| Kobe | Japan |
| Kurume | Japan |
| Matsuyama | Japan |
| Nagoya | Japan |
| Narita | Japan |
| Ohgaki | Japan |
| Okayama | Japan |
| Osaka | Japan |
| Sendai | Japan |
| Shibukawa | Japan |
| Shibuya City | Japan |
| Tachikawa | Japan |
| Toyohashi | Japan |
| Skopje | North Macedonia |
| Bialystok | Poland |
| Bydgoszcz | Poland |
| Chorzów | Poland |
| Gdansk | Poland |
| Legnica | Poland |
| Lublin | Poland |
| Opole | Poland |
| Słupsk | Poland |
| Warsaw | Poland |
| Warszawa Ul | Poland |
| Wroclaw | Poland |
| Lisbon | Portugal |
| Porto | Portugal |
| Brasov | Romania |
| Bucharest | Romania |
| Iași | Romania |
| Arkhangelsk | Russia |
| Dzerzhinsk | Russia |
| Nizhny Novgorod | Russia |
| Ryazan | Russia |
| Saint Petersburg | Russia |
| Saratov | Russia |
| Sochi | Russia |
| Volgograd | Russia |
| Yekaterinburg | Russia |
| Belgrade | Serbia |
| Kamenitz | Serbia |
| Niš | Serbia |
| Novi Sad | Serbia |
| Zemun | Serbia |
| Busan | South Korea |
| Gyeonggi-do | South Korea |
| Hwasun | South Korea |
| Incheon | South Korea |
| Seongnam | South Korea |
| Seoul | South Korea |
| Andalucía | Spain |
| Badalona | Spain |
| Barcelona | Spain |
| Córdoba | Spain |
| Girona | Spain |
| Madrid | Spain |
| Marañón | Spain |
| Murcia | Spain |
| Ourense | Spain |
| Pamplona | Spain |
| Salamanca | Spain |
| San Cristóbal de La Laguna | Spain |
| Seville | Spain |
| Toledo | Spain |
| Valencia | Spain |
| Zaragoza | Spain |
| Altındağ | Turkey (Türkiye) |
| Ankara | Turkey (Türkiye) |
| Aydin | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| Kayseri | Turkey (Türkiye) |
| Samsun | Turkey (Türkiye) |
| Tekirdağ | Turkey (Türkiye) |
| Cherkassy | Ukraine |
| Dnipro | Ukraine |
| Ivano-Frankivsk | Ukraine |
| Kharkiv | Ukraine |
| Khmelnitskiy | Ukraine |
| Lviv | Ukraine |
| Zaporizhzhia | Ukraine |
| Birmingham | United Kingdom |
| Cambridge | United Kingdom |
| Colchester | United Kingdom |
| Harlow | United Kingdom |
| Leicester | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Woolwich | United Kingdom |
| Derived |
| Mateos MV, San-Miguel J, Cavo M, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Yoon SS, Iosava G, Fujisaki T, Garg M, Ngo M, Katz EG, Krevvata M, Bolyard K, Carson R, Borgsten F, Dimopoulos MA. Bortezomib, melphalan, and prednisone with or without daratumumab in transplant-ineligible patients with newly diagnosed multiple myeloma (ALCYONE): final analysis of an open-label, randomised, multicentre, phase 3 trial. Lancet Oncol. 2025 May;26(5):596-608. doi: 10.1016/S1470-2045(25)00018-X. Epub 2025 Apr 9. |
| 34344638 | Derived | Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Yoon SS, Iosava G, Fujisaki T, Garg M, Iida S, Blade J, Ukropec J, Pei H, Van Rampelbergh R, Kudva A, Qi M, San-Miguel J. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):785-798. doi: 10.1016/j.clml.2021.06.005. Epub 2021 Jun 18. |
| 34289038 | Derived | Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101. |
| 34269818 | Derived | San-Miguel J, Avet-Loiseau H, Paiva B, Kumar S, Dimopoulos MA, Facon T, Mateos MV, Touzeau C, Jakubowiak A, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE. Blood. 2022 Jan 27;139(4):492-501. doi: 10.1182/blood.2020010439. |
| 34078314 | Derived | Knop S, Mateos MV, Dimopoulos MA, Suzuki K, Jakubowiak A, Doyen C, Lucio P, Nagy Z, Usenko G, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Losava G, Fujisaki T, Garg M, Wang J, Wroblewski S, Kudva A, Gries KS, Fastenau J, San-Miguel J, Cavo M. Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial. BMC Cancer. 2021 Jun 2;21(1):659. doi: 10.1186/s12885-021-08325-2. |
| 31836199 | Derived | Mateos MV, Cavo M, Blade J, Dimopoulos MA, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Krevvata M, Chen Y, Wang J, Kudva A, Ukropec J, Wroblewski S, Qi M, Kobos R, San-Miguel J. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. Lancet. 2020 Jan 11;395(10218):132-141. doi: 10.1016/S0140-6736(19)32956-3. Epub 2019 Dec 10. |
| 29231133 | Derived | Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Jakubowiak A, Knop S, Doyen C, Lucio P, Nagy Z, Kaplan P, Pour L, Cook M, Grosicki S, Crepaldi A, Liberati AM, Campbell P, Shelekhova T, Yoon SS, Iosava G, Fujisaki T, Garg M, Chiu C, Wang J, Carson R, Crist W, Deraedt W, Nguyen H, Qi M, San-Miguel J; ALCYONE Trial Investigators. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018 Feb 8;378(6):518-528. doi: 10.1056/NEJMoa1714678. Epub 2017 Dec 12. |
| FG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Velcade, Melphalan and Prednisone (VMP) | Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab. |
| BG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
| 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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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Stage of Disease (ISS) | The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<) 3.5 milligrams per liter (mg/L) and albumin greater than or equal to (>=) 3.5 grams per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/L. | Count of Participants | Participants |
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| Time from multiple myeloma (MM) diagnosis | Time from multiple myeloma (MM) diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group. | Mean | Standard Deviation | Months |
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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 | |||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) | PFS: duration from date of randomization to progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum M-component (absolute increase >=0.5 grams per deciliter [g/dL]); Urine M-component (absolute increase >=200 milligrams [mg]/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow Plasma cells (PC) percentage (%) (absolute % >=10%); Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. | Intent-to-treat (ITT) population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization (Day -3) up to 2.4 years |
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| Secondary | Overall Response Rate (ORR) | The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (>=) 50 percentage (%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Number | Percentage of participants | From randomization (Day -3) up to 2.4 years |
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| Secondary | Percentage of Participants With Very Good Partial Response (VGPR) or Better | VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Number | Percentage of participants | From randomization (Day -3) up to 2.4 years |
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| Secondary | Percentage of Participants With Complete Response (CR) or Better | CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Number | Percentage of participants | From randomization (Day -3) up to 2.4 years |
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| Secondary | Percentage of Participants With Stringent Complete Response (sCR) | sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; <5% plasma cells (PCs) in bone marrow. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Number | Percentage of participants | From randomization (Day -3) up to 2.4 years |
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| Secondary | Percentage of Participants With Negative Minimal Residual Disease (MRD) | The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Number | Percentage of participants | From randomization (Day -3) up to 8.3 years |
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| Secondary | Overall Survival (OS) | Overall Survival (OS) was measured from the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization (Day -3) up to 8.3 years |
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| Secondary | Progression Free Survival on Next Line of Therapy (PFS2) | Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization (Day -3) up to 8.3 years |
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| Secondary | Time to Disease Progression (TTP) | TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase >=0.5 g/dL); Urine M-component (absolute increase >=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % >=10%); Bone marrow PC %: absolute % >10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization (Day -3) up to 2.4 years |
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| Secondary | Time to Response | Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required. | Response-evaluable population: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening, must receive at least one component of study treatment and have adequate post-baseline disease assessments. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this endpoint. | Posted | Median | Full Range | Months | From randomization (Day -3) up to 2.4 years |
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| Secondary | Duration of Response (DOR) | DOR: participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase>=0.5 g/dL); Urine M-component (absolute increase>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%>=10%); Bone marrow PC's %: absolute%>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | Response-evaluable set: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must have received at least one component of study treatment and have adequate post-baseline disease assessments. Here 'N'(overall number of participants analyzed) signifies number of participants evaluable for this endpoint. | Posted | Median | 95% Confidence Interval | Months | From first documentation of response up to 2.4 years |
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| Secondary | Time to Next Treatment (TNT) | Time to next treatment is defined as the time from randomization to the start of the next-line treatment. Kaplan-Meier method was used for the analysis. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization (Day -3) up to 8.3 years |
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| Secondary | Percentage of Participants With Best M-protein Response | Percentage of participants with Best M- protein response of 100% reduction and >=90% to < 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC). | Response-evaluable set: participants have confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must receive at least one component of study treatment, have adequate post-baseline disease assessments. Here, 'n' (number analyzed) signifies number of participants analyzed for each specified category. | Posted | Number | Percentage of participants | Up to 2.4 years |
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| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score | The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values for function and GHS scale indicated deterioration in quality of life or functioning and positive values indicate improvement. | ITT population: participants randomized into the study; classified according to assigned treatment group, regardless actual treatment received. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Day -24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48 |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Global Health Scale | The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values for function and GHS scale indicated deterioration in quality of life or functioning and positive values indicate improvement. | ITT population: participants randomized into the study; classified according to assigned treatment group, regardless actual treatment received. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Day -24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48 |
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| Secondary | Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS) | EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. | ITT population: participants randomized into the study; classified according to assigned treatment group, regardless actual treatment received. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively. n=0 indicated that no participant was available for assessment at specified timepoint. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day- 24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48 |
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| Secondary | Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score | EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm. | ITT population: participants randomized into the study; classified according to assigned treatment group, regardless actual treatment received. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively. n=0 indicated that no participant was available for assessment at specified timepoint. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day -24), Months 3, 6, 9, 12 ,18, 24, 30, 36, 42 and 48 |
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| Post-Hoc | Progression Free Survival at Data Cutoff Date of 24 June 2019 | PFS: duration from date of randomization to PD/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum M-component (absolute increase >=0.5 g/dL); Urine M-component (absolute increase >=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow PC %(absolute % >=10%); Bone marrow PC %: absolute % >10 %; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder. | ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received. | Posted | Median | 95% Confidence Interval | Months | From randomization (Day -3) up to 4.4 years |
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All cause mortality: From randomization (Day -3) up to 8.3 years; Serious and Other AEs: From start of treatment (Day 1) up to 30 days after last dose of study treatment (up to 8.2 years)
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety population defined as participants who had received at least 1 administration of any study treatment (partial or complete) and were analyzed according to treatment actually 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 | Velcade, Melphalan and Prednisone (VMP) | Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab. | 217 | 356 | 117 | 354 | 331 | 354 |
| EG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). | 172 | 350 | 186 | 346 | 329 | 346 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Acute Coronary Syndrome | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Acute Left Ventricular Failure | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Angina Unstable | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Cardiac Failure Chronic | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Cardiovascular Insufficiency | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Sinus Node Dysfunction | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Stress Cardiomyopathy | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypertrophic Cardiomyopathy | Congenital, familial and genetic disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Abdominal Adhesions | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Abdominal Wall Haematoma | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Acute Abdomen | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Anal Haemorrhage | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Appendiceal Mucocoele | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Diverticular Perforation | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Femoral Hernia | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Gastric Dilatation | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Ileus Paralytic | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Oesophageal Rupture | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Oesophagitis Haemorrhagic | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Rectal Polyp | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Strangulated Hernia | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Abdominal Abscess | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Atypical Pneumonia | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Candida Sepsis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Clostridium Colitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cytomegalovirus Infection Reactivation | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Enterococcal Bacteraemia | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| H1n1 Influenza | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Herpes Zoster Disseminated | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Infected Fistula | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Infective Exacerbation of Chronic Obstructive Airways Disease | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Infective Myositis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection Bacterial | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Meningitis Pneumococcal | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Neutropenic Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pelvic Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumococcal Sepsis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumonia Streptococcal | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumonia Viral | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Postoperative Abscess | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pseudomembranous Colitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pulmonary Sepsis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Tuberculous Pleurisy | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Varicella Zoster Virus Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Vascular Device Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Chest Injury | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Heart Injury | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pelvic Bone Injury | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Traumatic Shock | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA V23.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA V23.0 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Troponin Increased | Investigations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Tumour Lysis Syndrome | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Adenocarcinoma of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Colorectal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hepatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Neuroendocrine Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Oesophageal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Prostatic Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Rectal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma of Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V23.0 | Non-systematic Assessment |
| |
| Autonomic Nervous System Imbalance | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Haemorrhage Intracranial | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Parkinson's Disease | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Peripheral Sensorimotor Neuropathy | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Prerenal Failure | Renal and urinary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Laryngeal Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Erythema Multiforme | Skin and subcutaneous tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Rash Vesicular | Skin and subcutaneous tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypovolaemic Shock | Vascular disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA V23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA V23.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V23.0 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Research and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2017 | Nov 21, 2018 | SAP_001.pdf |
| 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 |
|---|---|
| D000069286 | Bortezomib |
| D008558 | Melphalan |
| D011241 | Prednisone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
|
| Belgium |
|
| Brazil |
|
| Bulgaria |
|
| Croatia |
|
| Czech Republic |
|
| Georgia |
|
| Germany |
|
| Greece |
|
| Hungary |
|
| Italy |
|
| Japan |
|
| Poland |
|
| Portugal |
|
| Macedonia |
|
| Romania |
|
| Russia |
|
| Serbia |
|
| Korea, Republic of |
|
| Spain |
|
| Turkey |
|
| Ukraine |
|
| United Kingdom |
|
| United States |
|
| Stage II |
|
| Stage III |
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 |
| Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) |
Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
|
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
|
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Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.
| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
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| OG001 | Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) | Participants received Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). |
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