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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414SMM2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2014-005139-14 | EudraCT Number |
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The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.
This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 3-arm (3 treatment groups), multicenter study of daratumumab in participants diagnosed with intermediate or high-risk Smoldering Multiple Myeloma (SMM [ie, early disease without any symptoms]). Participants will be randomized (assigned by chance) to one of 3 treatment groups (arm A [long intense], arm B [intermediate] and arm C [short intense]) to receive daratumumab. Each treatment group will investigate 1 of 3 dosing schedules of daratumumab. The study will include a 28-Day Screening Phase, a Treatment Phase of 1 to 20 treatment cycles (each cycle is 8 weeks in duration for total period of 8 to 160 weeks), and a Follow up Phase of 4-weeks from the last dose of study drug. For participants in Arm A (long intense) and Arm B (intermediate), there is a possibility to extend treatment with IV daratumumab (Q8W) after the end of Cycle 20 if, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade >=3 treatment related toxicity, and at least stable disease has been achieved. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w). The Follow-up Phase will continue until death, lost to follow up, consent withdrawal, or study end, whichever occurs first. The end of the study will occur approximately 7 years after the last participant enrolled receives a first dose of study drug. 'Disease assessment will be performed locally per Standard of Care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Long Intense) | Experimental |
| |
| Arm B (Intermediate) | Experimental |
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| Arm C (Short Intense) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daratumumab | Drug | 16 mg/kg administered by intravenous (IV) infusion once every week in Cycle 1, every other week in Cycle 2 and Cycle 3, every 4 weeks in Cycle 4 to Cycle 7, and from Cycle 8 to Cycle 20 on Day 1 of each cycle. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Complete Response (CR) by International Myeloma Working Group (IMWG) Criteria | Percentage of participants who achieved a CR by IMWG Criteria were reported. CR was defined as CR plus stringent complete Response (sCR) by IMWG criteria. Per IMWG criteria, CR response was defined as a negative immunofixation on the serum and urine, and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR was defined as CR plus normal free light chain (FLC) ratio, and absence of clonal plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. | From Cycle 1 Day 1 up to 1.58 years |
| Progressive Disease or Death Rate | Progressive disease (PD) or death rate were reported. PD or death rate per patient-year was defined as number of events (PD or death) divided by total progression-free survival (PFS) for all participants. | From Cycle 1 Day 1 up to 2.07 years |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease (MRD) Negative Rate | MRD negative rate were reported. The MRD negativity rate was defined as the percentage of participants with a CR or better response who had negative MRD (10^-4 and 10^-5) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates at any time after the randomization and prior to progressive disease, subsequent therapy. |
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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 |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39652826 | Derived | Landgren O, Chari A, Cohen YC, Spencer A, Voorhees PM, Sandhu I, Jenner MW, Smith D, Cavo M, van de Donk NWCJ, Beksac M, Moreau P, Goldschmidt H, Vieyra D, Sha L, Li L, Rousseau E, Dennis R, Carson R, Hofmeister CC. Efficacy and safety of daratumumab in intermediate/high-risk smoldering multiple myeloma: final analysis of CENTAURUS. Blood. 2025 Apr 10;145(15):1658-1669. doi: 10.1182/blood.2024025897. | |
| 33474705 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Long Intense) | Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| 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 29, 2021 | Dec 17, 2025 |
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| daratumumab | Drug | 16 mg/kg administered by IV infusion once every week in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and every 8 weeks after Cycle 20. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w). |
|
| daratumumab | Drug | 16 mg/kg administered by IV infusion once every week in Cycle 1 only. Treatment cycles are 8 weeks in length. |
|
| From Cycle 1 Day 1 up to 91.6 months |
| Time to Next Treatment (TNT) for Active Myeloma | Time to next treatment (TNT) for active myeloma were reported. Time to next treatment was defined as the time from the date of randomization to the date of the first subsequent multiple myeloma treatment. Kaplan-Meier estimate was used. | From randomization (Day -5) up to the date of first subsequent antimyeloma treatment (up to 7.89 years) |
| Percentage of Participants Who Achieved Partial Response or Better Response (Stringent Complete Response [sCR] Plus Complete Response [CR] Plus Very Good Partial Response [VGPR] or a Partial Response [PR]) | Per IMWG criteria, CR: was defined as a negative immunofixation on serum and urine, and <5% plasma cells in bone marrow; sCR: CR plus normal FLC ratio, and absence of clonal plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hours; PR: >=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if serum and urine M-protein were not measurable, a decrease of >=50% in difference between involved and uninvolved FLC levels was required instead of M-protein criteria. If serum and urine M-protein were not measurable and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells was required in place of M-protein, provided baseline bone marrow plasma cells percentage was >=30%. | From start of the treatment (Cycle 1 Day 1) until confirmed PD, death, start of new anticancer therapy, withdrawal of consent, lost to follow-up, or end of the study, whichever occurred first (up to 7.89 years) |
| Progression Free Survival (PFS) | PFS: time from dates of randomization to initial documented PD per Sixty percent, bone marrow plasma cells (BMPC), Light chains, focal lesions per MRI, elevated Calcium, Renal failure, Anemia, Bone lesions (SLiM-CRAB) criteria, or date of death, whichever was first. SLiM-CRAB criteria: clonal BM PCs percentage (%): >=60%, Involved: uninvolved serum free LC ratio >=100, >1 focal lesion on MRI studies, calcium:>0.25 millimole/liter (mmol/L)(>1 mg/dL) higher than upper limit of normal or >2.75 mmol/L (>11 mg/dL); creatinine clearance <40 mL/min or serum creatinine >177 micromole/liter (>2 mg/dL); hemoglobin <10 g/dL(<6.5 mmol/L) or >2 g/dL(>1.25 mmol/L) lower than lower limit of normal;>1 osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-CT (PET-CT). Kaplan-Meier estimate was used. | From randomization (Day -5) until disease progression or death whichever occurred first (up to 7.89 years) |
| Percentage of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features | Percentage of participants with symptomatic multiple myeloma with adverse prognostic features were reported. The International Staging System (ISS) for multiple myeloma (MM) was based on serum beta-2 microglobulin (S beta-2M) and serum albumin; that is, participants progressed to symptomatic multiple myeloma (SymT MM) with stage III (S beta2M>= 5.5 mg/L) of ISS, Participants progressed to SymT MM with adverse cytogenetic characteristics (ACC), participants progressed to SymT MM with stage III of ISS or adverse cytogenetic characteristics. Adverse cytogenetic characteristics included Fluorescence in situ hybridization (FISH) findings of del(17p13), t(14;16), t(4;14), amp(1q21) or karyotype findings of t(4;14), del(17p) or a combination of these. | From start of treatment (Cycle 1 Day 1) until PD or prior to any subsequent anti-Multiple myeloma therapy (up to 7.89 years) |
| Number of Participants With Response to First Subsequent Multiple Myeloma Treatment | Response (IMWG Criteria) to first subsequent MM treatment: sCR: CR + normal FLC ratio and absence of clonal plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: a negative immunofixation on serum and urine, and <5% plasma cells in BM; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein <100mg/24 hours; PR:>=50% reduction of serum M-protein and >=90% reduction in urine M-protein in 24 hour or to <200 mg/24 hours; if serum and urine M-protein were not measurable, a decrease of >=50% difference between involved and uninvolved FLC levels was required instead of M-protein criteria. If serum and urine M-protein and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells was required instead of M-protein, provided bone marrow plasma cells percentage was >=30%. | From Cycle 1 Day 1 up to 7.89 years |
| Overall Survival | Overall Survival (OS) was defined as the time from the date of randomization to the date of death. Median OS was estimated by using the Kaplan-Meier method. | From randomization (Day -5) till death (up to 7.89 years) |
| Jacksonville |
| Florida |
| United States |
| West Palm Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| St Louis | Missouri | United States |
| Hackensack | New Jersey | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Seattle | Washington | United States |
| Box Hill | Australia |
| Concord | Australia |
| Melbourne | Australia |
| Woodville South | Australia |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Toronto | Ontario | Canada |
| Brno | Czechia |
| Hradec Králové | Czechia |
| Prague | Czechia |
| Lille | France |
| Nantes | France |
| Paris | France |
| Pierre-Bénite | France |
| Rennes | France |
| Berlin | Germany |
| Chemnitz | Germany |
| Essen | Germany |
| Heidelberg | Germany |
| Mainz | Germany |
| München | Germany |
| Tübingen | Germany |
| Würzburg | Germany |
| Haifa | Israel |
| Jerusalem | Israel |
| Petah Tikva | Israel |
| Tel Aviv | Israel |
| Amsterdam | Netherlands |
| Rotterdam | Netherlands |
| Utrecht | Netherlands |
| Nizhny Novgorod | Russia |
| Petrozavodsk | Russia |
| Ryazan | Russia |
| Saint Petersburg | Russia |
| Ankara | Turkey (Türkiye) |
| Antalya | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| Samsun | Turkey (Türkiye) |
| Cardiff | United Kingdom |
| Nottingham | United Kingdom |
| Southampton | United Kingdom |
| Surrey | United Kingdom |
| Derived |
| Chari A, Munder M, Weisel K, Jenner M, Bygrave C, Petrucci MT, Boccadoro M, Cavo M, van de Donk NWCJ, Turgut M, Demirkan F, Karadogan I, Libby E, Kleiman R, Kuppens S, Bandekar R, Neff T, Heuck C, Qi M, Clemens PL, Goldschmidt H. Evaluation of Cardiac Repolarization in the Randomized Phase 2 Study of Intermediate- or High-Risk Smoldering Multiple Myeloma Patients Treated with Daratumumab Monotherapy. Adv Ther. 2021 Feb;38(2):1328-1341. doi: 10.1007/s12325-020-01601-w. Epub 2021 Jan 20. |
| 32024950 | Derived | Landgren CO, Chari A, Cohen YC, Spencer A, Voorhees P, Estell JA, Sandhu I, Jenner MW, Williams C, Cavo M, van de Donk NWCJ, Beksac M, Moreau P, Goldschmidt H, Kuppens S, Bandekar R, Clemens PL, Neff T, Heuck C, Qi M, Hofmeister CC. Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS). Leukemia. 2020 Jul;34(7):1840-1852. doi: 10.1038/s41375-020-0718-z. Epub 2020 Feb 5. |
| FG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| FG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
| Participants Who Entered Extension Phase |
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| Participants Switched: Daratumumab IV to SC |
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| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Long Intense) | Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| BG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| BG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Stage I: low risk, serum beta-2 microglobulin was less than 3.5 milligrams per liter (mg/L) and the albumin level was above 3.5 grams per deciliter (g/dL); Stage II: Neither stage I or III, meaning that either: The beta-2 microglobulin level was between 3.5 to 5.5 mg/L (with any albumin level), OR the albumin was below 3.5 g/dL while the beta-2 microglobulin was less than 3.5 mg/L; Stage III: High risk, serum beta-2 microglobulin is greater than 5.5 mg/L. | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kilograms (Kg) |
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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 | Percentage of Participants Who Achieved a Complete Response (CR) by International Myeloma Working Group (IMWG) Criteria | Percentage of participants who achieved a CR by IMWG Criteria were reported. CR was defined as CR plus stringent complete Response (sCR) by IMWG criteria. Per IMWG criteria, CR response was defined as a negative immunofixation on the serum and urine, and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR was defined as CR plus normal free light chain (FLC) ratio, and absence of clonal plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. | Response evaluable analysis set included participants who had measurable disease at baseline as per IMWG criteria (serum and urine, serum only, urine only, FLC) and received at least 1 dose of daratumumab treatment and had at least 1 post-baseline disease assessment. | Posted | Number | percentage of participants | From Cycle 1 Day 1 up to 1.58 years |
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| Primary | Progressive Disease or Death Rate | Progressive disease (PD) or death rate were reported. PD or death rate per patient-year was defined as number of events (PD or death) divided by total progression-free survival (PFS) for all participants. | Intent-to-treat (ITT) analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on interactive web response system (IWRS). | Posted | Number | events per patient-year | From Cycle 1 Day 1 up to 2.07 years |
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| Secondary | Minimal Residual Disease (MRD) Negative Rate | MRD negative rate were reported. The MRD negativity rate was defined as the percentage of participants with a CR or better response who had negative MRD (10^-4 and 10^-5) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates at any time after the randomization and prior to progressive disease, subsequent therapy. | ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. | Posted | Number | percentage of participants | From Cycle 1 Day 1 up to 91.6 months |
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| Secondary | Time to Next Treatment (TNT) for Active Myeloma | Time to next treatment (TNT) for active myeloma were reported. Time to next treatment was defined as the time from the date of randomization to the date of the first subsequent multiple myeloma treatment. Kaplan-Meier estimate was used. | ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Posted | Median | 90% Confidence Interval | months | From randomization (Day -5) up to the date of first subsequent antimyeloma treatment (up to 7.89 years) |
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| Secondary | Percentage of Participants Who Achieved Partial Response or Better Response (Stringent Complete Response [sCR] Plus Complete Response [CR] Plus Very Good Partial Response [VGPR] or a Partial Response [PR]) | Per IMWG criteria, CR: was defined as a negative immunofixation on serum and urine, and <5% plasma cells in bone marrow; sCR: CR plus normal FLC ratio, and absence of clonal plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hours; PR: >=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if serum and urine M-protein were not measurable, a decrease of >=50% in difference between involved and uninvolved FLC levels was required instead of M-protein criteria. If serum and urine M-protein were not measurable and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells was required in place of M-protein, provided baseline bone marrow plasma cells percentage was >=30%. | Response evaluable analysis set included participants who had measurable disease at baseline as per IMWG criteria (serum and urine, serum only, urine only, FLC) and received at least 1 dose of daratumumab treatment and had at least 1 post-baseline disease assessment. | Posted | Number | 90% Confidence Interval | percentage of participants | From start of the treatment (Cycle 1 Day 1) until confirmed PD, death, start of new anticancer therapy, withdrawal of consent, lost to follow-up, or end of the study, whichever occurred first (up to 7.89 years) |
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| Secondary | Progression Free Survival (PFS) | PFS: time from dates of randomization to initial documented PD per Sixty percent, bone marrow plasma cells (BMPC), Light chains, focal lesions per MRI, elevated Calcium, Renal failure, Anemia, Bone lesions (SLiM-CRAB) criteria, or date of death, whichever was first. SLiM-CRAB criteria: clonal BM PCs percentage (%): >=60%, Involved: uninvolved serum free LC ratio >=100, >1 focal lesion on MRI studies, calcium:>0.25 millimole/liter (mmol/L)(>1 mg/dL) higher than upper limit of normal or >2.75 mmol/L (>11 mg/dL); creatinine clearance <40 mL/min or serum creatinine >177 micromole/liter (>2 mg/dL); hemoglobin <10 g/dL(<6.5 mmol/L) or >2 g/dL(>1.25 mmol/L) lower than lower limit of normal;>1 osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-CT (PET-CT). Kaplan-Meier estimate was used. | ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. | Posted | Median | 90% Confidence Interval | months | From randomization (Day -5) until disease progression or death whichever occurred first (up to 7.89 years) |
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| Secondary | Percentage of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features | Percentage of participants with symptomatic multiple myeloma with adverse prognostic features were reported. The International Staging System (ISS) for multiple myeloma (MM) was based on serum beta-2 microglobulin (S beta-2M) and serum albumin; that is, participants progressed to symptomatic multiple myeloma (SymT MM) with stage III (S beta2M>= 5.5 mg/L) of ISS, Participants progressed to SymT MM with adverse cytogenetic characteristics (ACC), participants progressed to SymT MM with stage III of ISS or adverse cytogenetic characteristics. Adverse cytogenetic characteristics included Fluorescence in situ hybridization (FISH) findings of del(17p13), t(14;16), t(4;14), amp(1q21) or karyotype findings of t(4;14), del(17p) or a combination of these. | ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. | Posted | Number | percentage of participants | From start of treatment (Cycle 1 Day 1) until PD or prior to any subsequent anti-Multiple myeloma therapy (up to 7.89 years) |
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| Secondary | Number of Participants With Response to First Subsequent Multiple Myeloma Treatment | Response (IMWG Criteria) to first subsequent MM treatment: sCR: CR + normal FLC ratio and absence of clonal plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: a negative immunofixation on serum and urine, and <5% plasma cells in BM; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein <100mg/24 hours; PR:>=50% reduction of serum M-protein and >=90% reduction in urine M-protein in 24 hour or to <200 mg/24 hours; if serum and urine M-protein were not measurable, a decrease of >=50% difference between involved and uninvolved FLC levels was required instead of M-protein criteria. If serum and urine M-protein and serum free light assay was also not measurable, >=50% reduction in bone marrow plasma cells was required instead of M-protein, provided bone marrow plasma cells percentage was >=30%. | ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure. Only those who received first line of therapy were analyzed. | Posted | Count of Participants | Participants | From Cycle 1 Day 1 up to 7.89 years |
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| Secondary | Overall Survival | Overall Survival (OS) was defined as the time from the date of randomization to the date of death. Median OS was estimated by using the Kaplan-Meier method. | ITT analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on IWRS. | Posted | Median | 90% Confidence Interval | months | From randomization (Day -5) till death (up to 7.89 years) |
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All-Cause Mortality: From randomization (Day -5) up to 7.89 years; Serious Adverse Events and Other Adverse Events: From Cycle 1 Day 1 up to 7.89 years
All Cause Mortality: All randomized participants; Serious Adverse Events and Other Adverse Events: Safety analysis set included participants who had received at least 1 administration of daratumumab (partial or complete).
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 | Arm A (Long Intense) | Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). | 7 | 41 | 20 | 41 | 38 | 41 |
| EG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). | 5 | 41 | 14 | 41 | 41 | 41 |
| EG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). | 4 | 41 | 4 | 40 | 32 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Babesiosis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Stress Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Haemangioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cervical Radiculopathy | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Prepuce Redundant | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Oral Pruritus | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Eye Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Taste Disorder | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Throat Tightness | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Skin Burning Sensation | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 25.1 | 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 withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Sciences Group Leader Onc | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2017 | Dec 17, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D000075122 | Smoldering 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 |
| D011230 | Precancerous Conditions |
| D006942 | Hypergammaglobulinemia |
Not provided
Not provided
| ID | Term |
|---|---|
| C556306 | daratumumab |
Not provided
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 |
|
| Canada |
|
| France |
|
| Germany |
|
| Israel |
|
| Italy |
|
| Netherlands |
|
| Russian Federation |
|
| Turkey |
|
| United Kingdom |
|
| United States |
|
| Stage II |
|
| Stage III |
|
| Arm B (Intermediate) |
Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
|
|
| OG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
|
|
| OG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
|
|
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
|
|
| OG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
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| OG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
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| OG001 | Arm B (Intermediate) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
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Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years). |
| OG002 | Arm C (Short Intense) | Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years). |
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