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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414MMY2002 | Other Identifier | Janssen Research & Development, LLC | |
| 2013-000752-18 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor [PI] and immunomodulatory drug [IMiD]) or are double refractory to a PI and an IMiD.
This is an open-label (identity of assigned study drug will be known) study of daratumumab for the treatment of participants with multiple myeloma who have received at least 3 prior lines of therapy including a PI and an IMiD or whose disease is double refractory to both a PI and an IMiD. Up to approximately 150 participants are to be enrolled. The study includes screening, treatment, and follow-up phases. Participants will receive daratumumab by intravenous infusion (28-day cycles) until disease progression, unacceptable toxicity, or other protocol-defined reasons. For all study drug administrations, participants will receive pre- and post-infusion medications for the prevention of infusion related reactions. Follow-up will continue until death, loss to follow up, consent withdrawal for study participation, or study end, whichever occurs first. The study will consist of 2 sequential parts (Part 1 and Part 2). The purpose of Part 1 is to select a dose and schedule for Part 2 of the study. Assessment of tumor response and disease progression will be conducted according to IMWG response criteria. Serial pharmacokinetic blood samples and a pharmacogenomic blood sample will be collected. Safety will be monitored throughout the study. At the end of the study, participants who are benefiting from treatment with daratumumab will have the option to continue treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | During Stage 1 of Part 1, participants will be randomized to receive daratumumab treatment regimens in Group A and Group B. If in Stage 1, 1 or both of the treatment groups is considered to be ineffective and/or not well tolerated, then that treatment group will be terminated. Participants in Group B will be given the option to cross over to Group A if the investigator deems it in the best interest of the participants. |
|
| Part 2 | Experimental | Based on the Part 1 response rate, Group A or B daratumumab treatment will be selected as the treatment regimen for participants enrolled in Part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab 16 mg/kg (Part 1) | Drug | Daratumumab 16 mg/kg administered at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter by intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response | Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; 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 < 100mg/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 the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. | Up to 14.4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be >=0.5 g/dL) and/or; urine M-component (the absolute increase must be >=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder. |
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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 |
|---|---|---|---|---|---|---|
| Duarte | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37022569 | Derived | Li X, Dosne AG, Perez Ruixo C, Perez Ruixo JJ. Pharmacodynamic-Mediated Drug Disposition (PDMDD) Model of Daratumumab Monotherapy in Patients with Multiple Myeloma. Clin Pharmacokinet. 2023 May;62(5):761-777. doi: 10.1007/s40262-023-01232-8. Epub 2023 Apr 6. | |
| 32470437 | Derived | Usmani SZ, Nahi H, Plesner T, Weiss BM, Bahlis NJ, Belch A, Voorhees PM, Laubach JP, van de Donk NWCJ, Ahmadi T, Uhlar CM, Wang J, Feng H, Qi M, Richardson PG, Lonial S. Daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma: final results from the phase 2 GEN501 and SIRIUS trials. Lancet Haematol. 2020 Jun;7(6):e447-e455. doi: 10.1016/S2352-3026(20)30081-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daratumumab 8 mg/kg | Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity. |
| FG001 | Daratumumab 16 mg/kg | Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Daratumumab 8 mg/kg (Part 1) | Drug | Daratumumab 8 mg/kg every 4 weeks (Q4W) continuously by intravenous infusion |
|
| Methylprednisolone | Drug | Administered in prophylactic doses intravenously (or equivalent in accordance with local standards) prior to and after study drug administration. Intravenous administration is preferred, but oral steroids may be substituted |
|
| Acetaminophen | Drug | 650 to 1000 mg administered in prophylactic doses by mouth prior to study drug administration. |
|
| Diphenhydramine | Drug | 25 to 50 mg administered in prophylactic doses by mouth (or equivalent in accordance with local standards) prior to and after study drug administration. |
|
| Daratumumab (Part 2) | Drug | Based on the Part 1 response rate, Group A or B treatment will be selected as the treatment regimen for participants enrolled in Part 2. |
|
| Up to 14.4 Months |
| Overall Survival | Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. | Approximately up to 3 years |
| Percentage of Participants With Clinical Benefit | Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: >=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas. | Up to 14.4 Months |
| Time to Response | Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). | Up to 14.4 Months |
| Progression Free Survival | Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first. | Up to 14.4 Months |
| Time to Disease Progression | Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression. | Up to 14.4 Months |
| Los Angeles |
| California |
| United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Louisville | Kentucky | United States |
| Detroit | Michigan | United States |
| New Brunswick | New Jersey | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Portland | Oregon | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Madison | Wisconsin | United States |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Halifax | Nova Scotia | Canada |
| Montreal | Quebec | Canada |
| Barcelona | Spain |
| Salamanca | Spain |
| Valencia | Spain |
| 30536810 | Derived | Adams HC 3rd, Stevenaert F, Krejcik J, Van der Borght K, Smets T, Bald J, Abraham Y, Ceulemans H, Chiu C, Vanhoof G, Usmani SZ, Plesner T, Lonial S, Nijhof I, Lokhorst HM, Mutis T, van de Donk NWCJ, Sasser AK, Casneuf T. High-Parameter Mass Cytometry Evaluation of Relapsed/Refractory Multiple Myeloma Patients Treated with Daratumumab Demonstrates Immune Modulation as a Novel Mechanism of Action. Cytometry A. 2019 Mar;95(3):279-289. doi: 10.1002/cyto.a.23693. Epub 2018 Dec 11. |
| 29445583 | Derived | Usmani SZ, Khan I, Chiu C, Foureau D, Druhan LJ, Rigby K, Casneuf T, Sasser AK. Deep sustained response to daratumumab monotherapy associated with T-cell expansion in triple refractory myeloma. Exp Hematol Oncol. 2018 Feb 7;7:3. doi: 10.1186/s40164-018-0096-7. eCollection 2018. |
| 27307294 | Derived | Nijhof IS, Casneuf T, van Velzen J, van Kessel B, Axel AE, Syed K, Groen RW, van Duin M, Sonneveld P, Minnema MC, Zweegman S, Chiu C, Bloem AC, Mutis T, Lokhorst HM, Sasser AK, van de Donk NW. CD38 expression and complement inhibitors affect response and resistance to daratumumab therapy in myeloma. Blood. 2016 Aug 18;128(7):959-70. doi: 10.1182/blood-2016-03-703439. Epub 2016 Jun 15. |
| 26778538 | Derived | Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, Bahlis NJ, Belch A, Krishnan A, Vescio RA, Mateos MV, Mazumder A, Orlowski RZ, Sutherland HJ, Blade J, Scott EC, Oriol A, Berdeja J, Gharibo M, Stevens DA, LeBlanc R, Sebag M, Callander N, Jakubowiak A, White D, de la Rubia J, Richardson PG, Lisby S, Feng H, Uhlar CM, Khan I, Ahmadi T, Voorhees PM. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016 Apr 9;387(10027):1551-1560. doi: 10.1016/S0140-6736(15)01120-4. Epub 2016 Jan 7. |
| COMPLETED |
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| NOT COMPLETED |
|
|
All treated Analysis Set included all participants who received at least 1 dose of daratumumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Daratumumab 8 mg/kg | Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity. |
| BG001 | Daratumumab 16 mg/kg | Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Stage of Disease (ISS) | The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (>=) 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin >= 5.5 mg/l. | Count of Participants | Participants |
| |||||||||||||||||
| Number of Prior Lines of Therapy | Count of Participants | Participants |
| ||||||||||||||||||
| Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory Drug (IMiD) | 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 With Overall Response | Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; 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 < 100mg/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 the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. | All treated analysis set included all participants who received at least 1 dose of daratumumab. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 14.4 Months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be >=0.5 g/dL) and/or; urine M-component (the absolute increase must be >=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder. | Responders in all treated analysis set. Only those participants with confirmed PR and those who experienced progressive disease were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 14.4 Months |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. | All treated analysis set included all participants who received at least 1 dose of daratumumab. | Posted | Median | 95% Confidence Interval | months | Approximately up to 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit | Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: >=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas. | All treated analysis set included all participants who received at least 1 dose of daratumumab. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 14.4 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Response | Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). | Responders in all treated analysis set. Only those participants with confirmed PR were analyzed. | Posted | Median | Full Range | months | Up to 14.4 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first. | All treated analysis set included all participants who received at least 1 dose of daratumumab. | Posted | Median | 95% Confidence Interval | months | Up to 14.4 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression. | All treated analysis set included all participants who received at least 1 dose of daratumumab. | Posted | Median | 95% Confidence Interval | months | Up to 14.4 Months |
|
|
Approximately up to 3.8 years
All treated Analysis Set included all participants who received at least 1 dose of daratumumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daratumumab 8 mg/kg | Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity. | 6 | 18 | 18 | 18 | ||
| EG001 | Daratumumab 16 mg/kg | Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity. | 33 | 106 | 105 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Faecal Incontinence | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Large Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| H1n1 Influenza | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Parainfluenzae Virus Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pneumonia Streptococcal | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Oxygen Saturation Abnormal | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Plasma Cell Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Cerumen Impaction | Ear and labyrinth disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Ear Discomfort | Ear and labyrinth disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Blood Urea Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Fluid Retention | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Anaesthesia | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Bladder Spasm | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Micturition Urgency | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nipple Pain | Reproductive system and breast disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Actinic Keratosis | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Nail Discolouration | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 18.0 | Non-systematic Assessment |
|
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Leader | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C556306 | daratumumab |
| D008775 | Methylprednisolone |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Spain |
|
| United States |
|
| II |
|
| III |
|
| > 3 Lines |
|
| PI only |
|
| IMiD only |
|
| None |
|
|
|
|
|
|
|
|