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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004203-41 | EudraCT Number | ||
| 54767414MMY2040 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | Experimental | Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4. |
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| D + Bortezomib + Melphalan + Prednisone (D-VMP) | Experimental | Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9. |
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| Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Experimental | Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug | Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts. |
| Measure | Description | Time Frame |
|---|---|---|
| D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg) per 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 is also required. | Up to 2 years 3 months |
| D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response | 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 <100 mg/24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% 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. | Up to 2 years and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Daratumumab | Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. | D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8 |
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Inclusion Criteria:
Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
Measurable, secretory disease as defined by any of the following:
Meets one of the sets of the following criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
During the study, during dose interruptions, and for 3 months after receiving the last dose of any component of the study treatment, a female participant must agree not to donate eggs (ova, oocytes) and male participants of reproductive potential must not donate semen or sperm during the study, during dose interruptions, or for 3 months after the last dose of any study drug
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 |
|---|---|---|---|---|---|---|
| Cancer Center of Central Connecticut - Southington | Southington | Connecticut | 06489-3237 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36882409 | Derived | Moreau P, Chari A, Oriol A, Martinez-Lopez J, Haenel M, Touzeau C, Ailawadhi S, Besemer B, de la Rubia Comos J, Encinas C, Mateos MV, Salwender H, Rodriguez-Otero P, Hulin C, Karlin L, Sureda Balari A, Bargay J, Benboubker L, Rosinol L, Tarantolo S, Terebelo H, Yang S, Wang J, Nnane I, Qi M, Kosh M, Delioukina M, Goldschmidt H. Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS. Blood Cancer J. 2023 Mar 7;13(1):33. doi: 10.1038/s41408-023-00805-x. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2022 | Nov 8, 2023 |
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| Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Experimental | Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study. |
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| Bortezomib | Drug | Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort. |
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| Lenalidomide | Drug | Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort. |
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| Dexamethasone | Drug | Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort. |
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| Melphalan | Drug | Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9. |
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| Prednisone | Drug | Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9. |
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| Carfilzomib | Drug | Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort. |
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| Percentage of Participants With Infusion-Related Reactions (IRRs) | Percentage of Participants with IRRs were reported. The administration-related systemic reactions are referred to as IRRs. | For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months |
| D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response | VGPR or better rate was defined as the percentage of participants who achieved VGPR or CR (including 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 <100 mg per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% 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 baseline up to 2 years 7 months |
| D-VRd Cohort: Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved a PR or better, IMWG criteria, during the study or during follow up. IMWG criteria for 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 is also required. | Up to 2 years and 3 months |
| Percentage of Participants With CR or Better Response | CR or better rate was defined as the percentage of participants with a CR or better response (that is, 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 FLC ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. | For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months |
| D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR) | DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | From baseline up to 2 years 7 months |
| Percentage of Participants With Anti-Daratumumab Antibodies | Percentage of participants with antibodies to daratumumab were reported. | For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months |
| Percentage of Participants With Anti-rHuPH20 Antibodies | Percentage of participants with antibodies to rHuPH20 were reported. | For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months |
| D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate | MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of <10^5. | Up to 2 years and 3 months |
| Mayo Clinic in Florida |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| UF Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | United States |
| Karmonos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Providence Cancer Center | Southfield | Michigan | 48075 | United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Nebraska Hematology and Oncology | Lincoln | Nebraska | 68506 | United States |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| NYU Winthrop | Mineola | New York | 11501 | United States |
| Mt. Sinai School of Medicine | New York | New York | 10029 | United States |
| Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
| Avera Medical Group - Oncology & Hematology | Sioux Falls | South Dakota | 57105 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84121 | United States |
| University of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic | Charlottesville | Virginia | 22903 | United States |
| Liga Norte Riograndense Contra O Cancer | Natal | 59062 000 | Brazil |
| Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo | Passo Fundo | 99010-090 | Brazil |
| Ministerio da Saude Instituto Nacional do Cancer | Rio de Janeiro | 20230 130 | Brazil |
| Clinica Sao Germano | São Paulo | 01455 010 | Brazil |
| SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo | São Paulo | 04037-002 | Brazil |
| Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE | São Paulo | 04039-004 | Brazil |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni Nemocnice Ostrava | Ostrava | 70852 | Czechia |
| Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie | Prague | 128 08 | Czechia |
| CHU de Nantes hotel Dieu | Nantes | 44093 | France |
| CHU de Bordeaux - Hospital Haut-Leveque | Pessac | 33604 | France |
| Centre hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| CHU Bretonneau | Tours | 37044 | France |
| CHU Nancy Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Klinikum Chemnitz gGmbH | Chemnitz | 09113 | Germany |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, | Tübingen | 72076 | Germany |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Carmel Medical Center | Haifa | 3436212 | Israel |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Kanazawa University Hospital | Kanazawa | 920 8641 | Japan |
| Matsuyama Red Cross Hospital | Matsuyama | 790-8524 | Japan |
| Nagoya City University Hospital | Nagoya | 467 8602 | Japan |
| Japanese Red Cross Medical Center | Shibuya City | 150-8935 | Japan |
| Inst. Cat. D'Oncologia-Badalona | Badalona | 08916 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Inst. Cat. Doncologia-H Duran I Reynals | Barcelona | 08908 | Spain |
| Hosp Univ Vall D Hebron | Barcelona | 8035 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Clinica Univ. de Navarra | Madrid | 28027 | Spain |
| Hosp. Univ. Ramon Y Cajal | Madrid | 28034 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Son Llatzer | Mallorca | 07198 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Univ. Dr. Peset | Valencia | 46017 | Spain |
| Heart of England NHS Foundation Trust | Birmingham | B9 5SS | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | CT1 3NG | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| FG001 | D + Bortezomib + Melphalan + Prednisone (D-VMP) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9. |
| FG002 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| FG003 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4. |
| BG001 | D + Bortezomib + Melphalan + Prednisone (D-VMP) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9. |
| BG002 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| BG003 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| BG004 | 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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| 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 | D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg) per 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 is also required. | All treated analysis set included all participants who have received at least 1 dose of study treatment. This primary outcome measure (OM) was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts only. | Posted | Number | 90% Confidence Interval | percentage of participants | Up to 2 years 3 months |
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| Primary | D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response | 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 <100 mg/24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% 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. | All treated analysis set included all participants who have received at least 1 dose of study treatment. This primary outcome measure (OM) was planned to be analyzed for D-VRd cohort only. | Posted | Number | 90% Confidence Interval | percentage of participants | Up to 2 years and 3 months |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Daratumumab | Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days. | Pharmacokinetics (PK) analysis set: participants who received at least 1 dose of daratumumab SC and had at least 1 PK sample value after first dose. 'N' (number of participants analyzed): participants evaluated for this OM; 'n' (number analyzed): participants analyzed at specific timepoints. The "0" in the number analyzed field indicates that no participant was evaluable for PK at that timepoint. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8 |
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| Secondary | Percentage of Participants With Infusion-Related Reactions (IRRs) | Percentage of Participants with IRRs were reported. The administration-related systemic reactions are referred to as IRRs. | All treated analysis set included all participants who have received at least 1 dose of study treatment. | Posted | Number | 90% Confidence Interval | percentage of participants | For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months |
| |||||||||||||||||||||||||||||||||
| Secondary | D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response | VGPR or better rate was defined as the percentage of participants who achieved VGPR or CR (including 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 <100 mg per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% 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. | All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts only. | Posted | Number | 90% Confidence Interval | percentage of participants | From baseline up to 2 years 7 months |
| |||||||||||||||||||||||||||||||||
| Secondary | D-VRd Cohort: Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved a PR or better, IMWG criteria, during the study or during follow up. IMWG criteria for 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 is also required. | All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VRd cohort only. | Posted | Number | 90% Confidence Interval | percentage of participants | Up to 2 years and 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR or Better Response | CR or better rate was defined as the percentage of participants with a CR or better response (that is, 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 FLC ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. | All treated analysis set included all participants who have received at least 1 dose of study treatment. | Posted | Number | 90% Confidence Interval | percentage of participants | For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months |
| |||||||||||||||||||||||||||||||||
| Secondary | D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR) | DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder. | Analysis population included number of responders (partial response or better) in each cohort. This secondary outcome measure was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts. | Posted | Median | Full Range | months | From baseline up to 2 years 7 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Daratumumab Antibodies | Percentage of participants with antibodies to daratumumab were reported. | Immunogenicity-evaluable analysis set was defined as all participants who received at least 1 dose administration of daratumumab SC and had at least 1 immunogenicity sample for detection of anti-daratumumab antibodies after the first dose. | Posted | Number | percentage of participants | For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-rHuPH20 Antibodies | Percentage of participants with antibodies to rHuPH20 were reported. | Immunogenicity-evaluable analysis set for rHuPH20 is defined as all participants who received at least one dose of daratumumab SC and had appropriate plasma samples for detection of antibodies to rHuPH20 (at least 1 sample after the start of the first dose of daratumumab SC). | Posted | Number | percentage of participants | For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate | MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of <10^5. | All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts only. | Posted | Number | 90% Confidence Interval | percentage of participants | Up to 2 years and 3 months |
|
For D-VRD Arm: Baseline up to 2 years 3 months; For D-VMP, D-Rd and D-Kd Arms: Baseline up to 2 years 7 months
All treated analysis set included all participants who received at least 1 dose of study treatment.
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 | Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) | Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4. | 1 | 67 | 19 | 67 | 67 | 67 |
| EG001 | D + Bortezomib + Melphalan + Prednisone (D-VMP) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9. | 3 | 67 | 30 | 67 | 67 | 67 |
| EG002 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. | 4 | 65 | 37 | 65 | 65 | 65 |
| EG003 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. | 5 | 66 | 22 | 66 | 66 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Ophthalmic Vein Thrombosis | Eye disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Campylobacter Gastroenteritis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Diarrhoea Infectious | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Enterobacter Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Infective Exacerbation of Chronic Obstructive Airways Disease | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pneumococcal Sepsis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Viral Pharyngitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Thoracic Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Body Temperature Increased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Respirovirus Test Positive | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Diabetic Metabolic Decompensation | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Adenocarcinoma Pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hepatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Plasma Cell Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Cerebellar Haematoma | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Cerebral Small Vessel Ischaemic Disease | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Incoherent | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Loss of Consciousness | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Thalamic Infarction | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Vith Nerve Paresis | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Uterine Prolapse | Reproductive system and breast disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Cardiac Ablation | Surgical and medical procedures | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Sleep Disorder | Psychiatric disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Rash Generalised | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V21.1&23.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GLOBAL MEDICAL HEAD | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2020 | Nov 8, 2023 | SAP_003.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 |
|---|---|
| C556306 | daratumumab |
| D000069286 | Bortezomib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D008558 | Melphalan |
| D011241 | Prednisone |
| C524865 | carfilzomib |
| 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 |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 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 |
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 |
|
| CZECH REPUBLIC |
|
| FRANCE |
|
| GERMANY |
|
| ISRAEL |
|
| JAPAN |
|
| SPAIN |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9. |
| OG002 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| OG003 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
|
|
| OG002 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| OG003 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
|
|
| OG001 |
| Daratumumab + Lenalidomide + Dexamethasone (D-Rd) |
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| OG002 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
|
|
|
|
| OG002 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| OG003 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
|
|
| OG001 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| OG002 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
|
|
| OG002 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| OG003 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
|
|
| OG002 | Daratumumab + Lenalidomide + Dexamethasone (D-Rd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
| OG003 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
|
|
| OG002 | Daratumumab + Carfilzomib + Dexamethasone (D-Kd) | Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 7 months. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|