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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003328-22 | EudraCT Number | ||
| 56022473MDS2002 | Other Identifier | Janssen Research & Development, LLC |
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The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).
This is a multicenter, randomized (study drug assigned by chance), open-label (participants and researchers are aware of the treatment participants are receiving) study to evaluate the safety and efficacy of talacotuzumab or daratumumab. Approximately 60 participants (30 to receive talacotuzumab and 30 to receive daratumumab) will be enrolled and then assigned randomly on a 1:1 basis to receive either talacotuzumab or daratumumab. The study consists of: a Screening Phase of up to 28 days during which participant eligibility will be reviewed and approved by the sponsor prior to randomization, a Treatment Phase that will extend from the first dose on Cycle 1 Day 1 until study drug discontinuation, and a Post-treatment Follow up Phase beginning once the participant discontinues talacotuzumab or daratumumab. Study drugs will continue to be administered until disease progression, lack of response, unacceptable toxicity, withdrawal of consent, or study end. Safety will be monitored throughout the study. The talacotuzumab arm of the study is closed for enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talacotuzumab | Experimental | Participants will receive talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 for all cycles. Each treatment cycle is of 28 days. The talacotuzumab arm of the study is closed for enrollment. |
|
| Daratumumab | Experimental | Participants will receive daratumumab 16 mg/kg IV on Days 1, 8, 15, and 22 for Cycles 1 and 2; on Days 1 and 15 for Cycles 3 to 6; and on Day 1 for all subsequent cycles. Each treatment cycle is of 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talacotuzumab | Drug | Talacotuzumab 9 mg/kg will be administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks | Percentage of participants who achieved RBC TI lasting at least 8 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 24 Weeks | Percentage of participants who achieved RBC TI lasting at least 24 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization. | Up to 2 years |
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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 |
|---|---|---|---|---|---|---|
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States | ||
| University of Pennsylvania Abramson Cancer Center |
Due to serious infusion-related reaction (IRR) event that occurred in first participant enrolled in talacotuzumab arm, no further participants were enrolled in this arm.
Out of 34 enrolled participants, 33 participants received daratumumab and 1 participant received talacotuzumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Talacotuzumab | Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV). |
| FG001 | Daratumumab | Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days. |
| 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 | Dec 13, 2018 | Jan 20, 2020 |
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| Daratumumab | Drug | Daratumumab 16 mg/kg will be administered as an IV infusion. |
|
|
| Time to Transfusion Independence (TI) |
Time to transfusion independence (TI) was defined as time to the start of the TI interval. TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization. |
| Up to 2 years |
| Duration of Transfusion Independence (TI) | Duration of TI was reported. TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization. | Up to 2 years |
| Percentage of Participants Who Met IWG Criteria for Transfusion Reduction | Percentage of participants who met IWG criteria for transfusion reduction were reported. IWG criteria for transfusion reduction: at least 4 units reduction in RBC transfusions in the best 8-week interval. The best 8-week interval was a post-baseline 8-week interval where the participant had the fewest post-baseline RBC transfusion units. | Up to 2 years |
| Percentage of Participants With at Least One Dose of Myeloid Growth Factors Usage | Percentage of participants with Myeloid Growth Factors (MGF) usage (who had used at least 1 dose of MGF) were reported. | Up to 2 years |
| Percentage of Participants With Hematologic Improvement (HI) Per IWG 2006 by Investigator Assessment | Percentage of participants with HI per International Working Group (IWG) 2006 by investigator assessment were reported. Response criteria per IWG 2006 for HI: Erythroid response (pretreatment, less than [<]11 gram per deciliter [g/dL]) - hemoglobin increase by greater than or equal to (>=)1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hb of <=9 g/dL pretreatment counted in the RBC transfusion response evaluation; Platelet response (pretreatment, <100*10^9/L) - absolute increase of >=30*10^9/L for participants starting with >20*10^9/L platelets. Increase from <20*10^9/L to >20*10^9/L and by at least 100 percent (%); Neutrophil response (pretreatment, <1*10^9/L) - at least 100% increase and an absolute increase >0.5*10^9/L. | Up to 2 years |
| Percentage of Participants With Complete Remission (CR) and Marrow CR | Percentage of participants with CR and marrow CR were reported. CR per International Working Group (IWG) 2006 Response criteria: Bone marrow - less than or equal to (<=)5% myeloblasts with normal maturation of all cell lines, persistent dysplasia noted; Peripheral blood - hemoglobin >=11 g/dL; platelets >=100*10^9/L; neutrophils >=1.0*10^9/L; blasts, 0%. Marrow CR: Bone marrow - <=5% myeloblasts and decrease by >=50% over pretreatment; Peripheral blood - if HI responses, they were noted in addition to marrow CR. | Up to 2 years |
| Percentage of Participants With Partial Remission (PR) | Percentage of participants with PR were reported. PR per International Working Group (IWG) 2006 Response criteria: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by >=50% over pretreatment but still >5%, cellularity and morphology not relevant. | Up to 2 years |
| Percentage of Participants With Cytogenetic Response | Percentage of participants with cytogenetic response were reported. Cytogenetic response per International Working Group (IWG) 2006 Response criteria: Complete - disappearance of the chromosomal abnormality without appearance of new ones; Partial - at least 50% reduction of the chromosomal abnormality. | Up to 2 years |
| Overall Survival | The overall survival was defined as the time from the date of first dose of study drug to date of death from any cause. Median overall survival was estimated by using the Kaplan-Meier method. | Up to 2 years |
| Time to Progression to Acute Myeloid Leukemia (AML) | Time to progression to acute myeloid leukemia was reported. Disease progression as per IWG response criteria: For participants with: <5% blasts: >=50% increase in blasts to >5% blasts; 5%-10% blasts: >=50% increase to >10% blasts; 10%-20% blasts: >=50% increase to >20% blasts; 20%-30% blasts: >=50% increase to >30% blasts. Any of the following: >=50% decrement from maximum remission/response in granulocytes or platelets; reduction in hemoglobin by >=2 g/dL; transfusion dependence. | Up to 2 years |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ZNA Stuivenberg | Antwerp | 2060 | Belgium |
| Az Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| AZ Turnhout | Turnhout | 2300 | Belgium |
| Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna | Bologna | 40138 | Italy |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50134 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora | Milan | 20122 | Italy |
| Istituto Clinico Humanitas | Rozzano | 20089 | Italy |
| UMCG | Groningen | 9713 GZ | Netherlands |
| Erasmus MC | Rotterdam | 3075 EA | Netherlands |
| Haga ziekenhuis | The Hague | 2545 CH | Netherlands |
| City Clinical Hospital # 40 | Moscow | 129301 | Russia |
| Nizhniy Novgorod Region Clinical Hospital | Nizhny Novgorod | 603126 | Russia |
| Saint Petersburg City Hospital #15 | Saint Petersburg | 123182 | Russia |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp. Univ. de La Princesa | Madrid | 28006 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46026 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Talacotuzumab | Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV). |
| BG001 | Daratumumab | Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks | Percentage of participants who achieved RBC TI lasting at least 8 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization. | Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 2 years |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 24 Weeks | Percentage of participants who achieved RBC TI lasting at least 24 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Transfusion Independence (TI) | Time to transfusion independence (TI) was defined as time to the start of the TI interval. TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization. | ITT population who achieved TI for at least 8 weeks. As less number of participants were evaluable for this outcome measure (OM), the results were not summarized. Hence, participant wise data is reported. | Posted | Number | Weeks | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Transfusion Independence (TI) | Duration of TI was reported. TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization. | ITT population who achieved TI for at least 8 weeks. As less number of participants were evaluable for this outcome measure (OM), the results were not summarized. Hence, participant wise data is reported. | Posted | Number | Weeks | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Met IWG Criteria for Transfusion Reduction | Percentage of participants who met IWG criteria for transfusion reduction were reported. IWG criteria for transfusion reduction: at least 4 units reduction in RBC transfusions in the best 8-week interval. The best 8-week interval was a post-baseline 8-week interval where the participant had the fewest post-baseline RBC transfusion units. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Dose of Myeloid Growth Factors Usage | Percentage of participants with Myeloid Growth Factors (MGF) usage (who had used at least 1 dose of MGF) were reported. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hematologic Improvement (HI) Per IWG 2006 by Investigator Assessment | Percentage of participants with HI per International Working Group (IWG) 2006 by investigator assessment were reported. Response criteria per IWG 2006 for HI: Erythroid response (pretreatment, less than [<]11 gram per deciliter [g/dL]) - hemoglobin increase by greater than or equal to (>=)1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hb of <=9 g/dL pretreatment counted in the RBC transfusion response evaluation; Platelet response (pretreatment, <100*10^9/L) - absolute increase of >=30*10^9/L for participants starting with >20*10^9/L platelets. Increase from <20*10^9/L to >20*10^9/L and by at least 100 percent (%); Neutrophil response (pretreatment, <1*10^9/L) - at least 100% increase and an absolute increase >0.5*10^9/L. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Remission (CR) and Marrow CR | Percentage of participants with CR and marrow CR were reported. CR per International Working Group (IWG) 2006 Response criteria: Bone marrow - less than or equal to (<=)5% myeloblasts with normal maturation of all cell lines, persistent dysplasia noted; Peripheral blood - hemoglobin >=11 g/dL; platelets >=100*10^9/L; neutrophils >=1.0*10^9/L; blasts, 0%. Marrow CR: Bone marrow - <=5% myeloblasts and decrease by >=50% over pretreatment; Peripheral blood - if HI responses, they were noted in addition to marrow CR. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Partial Remission (PR) | Percentage of participants with PR were reported. PR per International Working Group (IWG) 2006 Response criteria: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by >=50% over pretreatment but still >5%, cellularity and morphology not relevant. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Cytogenetic Response | Percentage of participants with cytogenetic response were reported. Cytogenetic response per International Working Group (IWG) 2006 Response criteria: Complete - disappearance of the chromosomal abnormality without appearance of new ones; Partial - at least 50% reduction of the chromosomal abnormality. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Up to 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The overall survival was defined as the time from the date of first dose of study drug to date of death from any cause. Median overall survival was estimated by using the Kaplan-Meier method. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Progression to Acute Myeloid Leukemia (AML) | Time to progression to acute myeloid leukemia was reported. Disease progression as per IWG response criteria: For participants with: <5% blasts: >=50% increase in blasts to >5% blasts; 5%-10% blasts: >=50% increase to >10% blasts; 10%-20% blasts: >=50% increase to >20% blasts; 20%-30% blasts: >=50% increase to >30% blasts. Any of the following: >=50% decrement from maximum remission/response in granulocytes or platelets; reduction in hemoglobin by >=2 g/dL; transfusion dependence. | ITT population included all participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | Weeks | Up to 2 years |
|
|
Up to 2 years
Safety population included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Talacotuzumab | Participant received a single dose of talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV). | 0 | 1 | 1 | 1 | 1 | 1 |
| EG001 | Daratumumab | Participants received daratumumab 16 mg/kg IV weekly on Weeks 1 to 8 (on Days 1, 8, 15, and 22 for Cycles 1 and 2), every 2 weeks for Weeks 9 to 24 (on Days 1 and 15 for Cycles 3 to 6), and every 4 weeks thereafter (on Day 1 for all subsequent cycles). Each treatment cycle was 28 days. | 6 | 33 | 15 | 33 | 33 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Autoimmune Disorder | Immune system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Corona Virus Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Lung Infection Pseudomonal | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hepatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Laryngeal Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Thrombophlebitis Superficial | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Conjunctival Haemorrhage | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Campylobacter Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
Study objectives were not pursued in talacotuzumab arm; enrollment in this arm was stopped due to a serious infusion-related reaction after first dose in first participant assigned to talacotuzumab.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2018 | Jan 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C556306 | daratumumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| White |
|
| ITALY |
|
| NETHERLANDS |
|
| RUSSIAN FEDERATION |
|
| SPAIN |
|
| UNITED STATES |
|
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|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
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|
|
| Participants |
|
|