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Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02136134
Recruitment Status : Active, not recruiting
First Posted : May 12, 2014
Results First Posted : February 10, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Daratumumab
Drug: VELCADE (Bortezomib)
Drug: Dexamethasone
Enrollment 499
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Hide Arm/Group Description Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Period Title: Overall Study
Started 247 251
Treated 237 243
Completed 0 0
Not Completed 247 251
Reason Not Completed
Death             35             29
Withdrawal by Subject             14             4
Other             3             3
Ongoing             185             207
Subjects randomized but not treated             10             8
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd) Total
Hide Arm/Group Description Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Total of all reporting groups
Overall Number of Baseline Participants 247 251 498
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 247 participants 251 participants 498 participants
63.9  (9.81) 62.8  (9.66) 63.3  (9.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 498 participants
Female
100
  40.5%
114
  45.4%
214
  43.0%
Male
147
  59.5%
137
  54.6%
284
  57.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 498 participants
Australia 20 23 43
Brazil 9 13 22
Czech Republic 19 16 35
Germany 21 21 42
Hungary 14 16 30
Italy 25 24 49
Korea, Republic of 8 10 18
Mexico 1 2 3
Netherlands 14 11 25
Poland 18 16 34
Russian Federation 13 21 34
Spain 19 10 29
Sweden 9 10 19
Turkey 14 14 28
Ukraine 22 28 50
United States 21 16 37
Stage of Disease (ISS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 498 participants
I 96 98 194
II 100 94 194
III 51 59 110
[1]
Measure Description: The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (>=) 3.5 gram per 100 Milliliter (g/100 ml); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/l.
No. of Prior Lines of Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 498 participants
1 113 122 235
2 74 70 144
3 32 37 69
>3 28 22 50
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Time Frame From the date of randomization to either progressive disease or death, whichever occurs first (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Hide Arm/Group Description:
Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Overall Number of Participants Analyzed 247 251
Median (95% Confidence Interval)
Unit of Measure: months
7.16
(6.21 to 7.85)
NA [1] 
(12.25 to NA)
[1]
Median and Upper limit of 95% CI was not estimable due to short follow-up by participants.
2.Secondary Outcome
Title Time to Disease Progression (TTP)
Hide Description TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.
Time Frame From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurs first (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Hide Arm/Group Description:
Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Overall Number of Participants Analyzed 247 251
Median (95% Confidence Interval)
Unit of Measure: months
7.29
(6.41 to 8.08)
NA [1] 
(12.25 to NA)
[1]
Median and Upper limit of 95% CI was not estimable due to short follow-up by participants.
3.Secondary Outcome
Title Percentage of Participants With a Very Good Partial Response (VGPR) or Better
Hide Description Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.
Time Frame Up to disease progression (approximately of 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The response evaluable analysis set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment, and had at least 1 post baseline disease assessment.
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Hide Arm/Group Description:
Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Overall Number of Participants Analyzed 234 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.1
(23.3 to 35.3)
59.2
(52.7 to 65.4)
4.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.
Time Frame Up to disease progression (approximately of 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable analysis set is defined as participants who have confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment and had at least 1 post baseline disease assessment.
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Hide Arm/Group Description:
Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Overall Number of Participants Analyzed 234 240
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.2
(56.7 to 69.4)
82.9
(77.5 to 87.5)
5.Secondary Outcome
Title Percentage of Participants With Negative Minimal Residual Disease (MRD)
Hide Description The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.
Time Frame Up to disease progression (approximately of 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Hide Arm/Group Description:
Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Overall Number of Participants Analyzed 247 251
Measure Type: Number
Unit of Measure: percentage of participants
2.8 13.5
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival was measured from the date of randomization to the date of the participant's death.
Time Frame Up to the end of the study (approximately of 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Hide Arm/Group Description:
Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
Overall Number of Participants Analyzed 247 251
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and 95% CI was not estimable due to short follow-up by participants.
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population included all randomized participants who had at least 1 administration of any of the study treatment (partial or complete).
 
Arm/Group Title Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Hide Arm/Group Description Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
All-Cause Mortality
Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Affected / at Risk (%) Affected / at Risk (%)
Total   80/237 (33.76%)   102/243 (41.98%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/237 (0.42%)  8/243 (3.29%) 
Febrile Neutropenia * 1  0/237 (0.00%)  2/243 (0.82%) 
Neutropenia * 1  0/237 (0.00%)  2/243 (0.82%) 
Thrombocytopenia * 1  1/237 (0.42%)  6/243 (2.47%) 
Cardiac disorders     
Acute Coronary Syndrome * 1  0/237 (0.00%)  1/243 (0.41%) 
Acute Myocardial Infarction * 1  0/237 (0.00%)  1/243 (0.41%) 
Arrhythmia Supraventricular * 1  0/237 (0.00%)  1/243 (0.41%) 
Atrial Fibrillation * 1  0/237 (0.00%)  5/243 (2.06%) 
Cardiac Arrest * 1  1/237 (0.42%)  1/243 (0.41%) 
Cardiac Failure * 1  0/237 (0.00%)  1/243 (0.41%) 
Cardiac Failure Congestive * 1  1/237 (0.42%)  2/243 (0.82%) 
Cardiogenic Shock * 1  1/237 (0.42%)  1/243 (0.41%) 
Myocardial Infarction * 1  2/237 (0.84%)  0/243 (0.00%) 
Ventricular Extrasystoles * 1  1/237 (0.42%)  0/243 (0.00%) 
Endocrine disorders     
Adrenal Insufficiency * 1  1/237 (0.42%)  0/243 (0.00%) 
Hyperthyroidism * 1  0/237 (0.00%)  1/243 (0.41%) 
Eye disorders     
Diplopia * 1  0/237 (0.00%)  1/243 (0.41%) 
Gastrointestinal disorders     
Abdominal Pain * 1  3/237 (1.27%)  0/243 (0.00%) 
Abdominal Pain Upper * 1  0/237 (0.00%)  1/243 (0.41%) 
Constipation * 1  3/237 (1.27%)  0/243 (0.00%) 
Diarrhoea * 1  0/237 (0.00%)  4/243 (1.65%) 
Diverticular Perforation * 1  0/237 (0.00%)  1/243 (0.41%) 
Duodenal Ulcer * 1  0/237 (0.00%)  1/243 (0.41%) 
Faecaloma * 1  1/237 (0.42%)  0/243 (0.00%) 
Gastritis * 1  0/237 (0.00%)  1/243 (0.41%) 
Incarcerated Umbilical Hernia * 1  1/237 (0.42%)  0/243 (0.00%) 
Intestinal Obstruction * 1  0/237 (0.00%)  1/243 (0.41%) 
Melaena * 1  0/237 (0.00%)  1/243 (0.41%) 
Pancreatitis Acute * 1  0/237 (0.00%)  1/243 (0.41%) 
Pancreatitis Chronic * 1  0/237 (0.00%)  1/243 (0.41%) 
Small Intestinal Obstruction * 1  0/237 (0.00%)  1/243 (0.41%) 
General disorders     
Asthenia * 1  3/237 (1.27%)  0/243 (0.00%) 
Condition Aggravated * 1  3/237 (1.27%)  0/243 (0.00%) 
Fatigue * 1  0/237 (0.00%)  2/243 (0.82%) 
General Physical Health Deterioration * 1  3/237 (1.27%)  1/243 (0.41%) 
Influenza Like Illness * 1  1/237 (0.42%)  0/243 (0.00%) 
Oedema Peripheral * 1  0/237 (0.00%)  1/243 (0.41%) 
Pain * 1  0/237 (0.00%)  1/243 (0.41%) 
Pyrexia * 1  4/237 (1.69%)  4/243 (1.65%) 
Infections and infestations     
Bacterial Infection * 1  1/237 (0.42%)  0/243 (0.00%) 
Brain Abscess * 1  1/237 (0.42%)  0/243 (0.00%) 
Bronchitis * 1  1/237 (0.42%)  5/243 (2.06%) 
Bronchopneumonia * 1  1/237 (0.42%)  3/243 (1.23%) 
Cellulitis * 1  0/237 (0.00%)  1/243 (0.41%) 
Epididymitis * 1  1/237 (0.42%)  0/243 (0.00%) 
Fungal Oesophagitis * 1  0/237 (0.00%)  1/243 (0.41%) 
Gangrene * 1  1/237 (0.42%)  0/243 (0.00%) 
Gastroenteritis * 1  3/237 (1.27%)  2/243 (0.82%) 
Herpes Zoster * 1  2/237 (0.84%)  1/243 (0.41%) 
Influenza * 1  2/237 (0.84%)  0/243 (0.00%) 
Lobar Pneumonia * 1  1/237 (0.42%)  0/243 (0.00%) 
Lower Respiratory Tract Infection * 1  2/237 (0.84%)  2/243 (0.82%) 
Lung Infection * 1  1/237 (0.42%)  1/243 (0.41%) 
Metapneumovirus Infection * 1  0/237 (0.00%)  1/243 (0.41%) 
Nocardiosis * 1  1/237 (0.42%)  0/243 (0.00%) 
Ophthalmic Herpes Simplex * 1  1/237 (0.42%)  0/243 (0.00%) 
Peritonitis * 1  0/237 (0.00%)  1/243 (0.41%) 
Pneumocystis Jirovecii Pneumonia * 1  0/237 (0.00%)  1/243 (0.41%) 
Pneumonia * 1  22/237 (9.28%)  19/243 (7.82%) 
Pneumonia Cytomegaloviral * 1  0/237 (0.00%)  2/243 (0.82%) 
Pneumonia Pneumococcal * 1  0/237 (0.00%)  1/243 (0.41%) 
Pulmonary Sepsis * 1  0/237 (0.00%)  2/243 (0.82%) 
Pyelonephritis * 1  0/237 (0.00%)  1/243 (0.41%) 
Pyelonephritis Chronic * 1  1/237 (0.42%)  0/243 (0.00%) 
Respiratory Syncytial Virus Infection * 1  0/237 (0.00%)  1/243 (0.41%) 
Respiratory Tract Infection * 1  1/237 (0.42%)  0/243 (0.00%) 
Rhinovirus Infection * 1  0/237 (0.00%)  1/243 (0.41%) 
Sepsis * 1  2/237 (0.84%)  2/243 (0.82%) 
Septic Shock * 1  1/237 (0.42%)  0/243 (0.00%) 
Sinusitis * 1  0/237 (0.00%)  1/243 (0.41%) 
Tracheobronchitis * 1  1/237 (0.42%)  0/243 (0.00%) 
Upper Respiratory Tract Infection * 1  2/237 (0.84%)  4/243 (1.65%) 
Urinary Tract Infection * 1  1/237 (0.42%)  0/243 (0.00%) 
Injury, poisoning and procedural complications     
Contusion * 1  1/237 (0.42%)  0/243 (0.00%) 
Femur Fracture * 1  0/237 (0.00%)  2/243 (0.82%) 
Hip Fracture * 1  1/237 (0.42%)  1/243 (0.41%) 
Humerus Fracture * 1  0/237 (0.00%)  2/243 (0.82%) 
Rib Fracture * 1  1/237 (0.42%)  1/243 (0.41%) 
Spinal Fracture * 1  0/237 (0.00%)  1/243 (0.41%) 
Subdural Haematoma * 1  1/237 (0.42%)  0/243 (0.00%) 
Thoracic Vertebral Fracture * 1  1/237 (0.42%)  0/243 (0.00%) 
Upper Limb Fracture * 1  0/237 (0.00%)  1/243 (0.41%) 
Investigations     
Alanine Aminotransferase Increased * 1  0/237 (0.00%)  1/243 (0.41%) 
Electrocardiogram QT Interval Abnormal * 1  0/237 (0.00%)  1/243 (0.41%) 
Gamma-Glutamyltransferase Increased * 1  0/237 (0.00%)  1/243 (0.41%) 
Metabolism and nutrition disorders     
Dehydration * 1  2/237 (0.84%)  1/243 (0.41%) 
Hypercalcaemia * 1  0/237 (0.00%)  2/243 (0.82%) 
Hyperglycaemia * 1  2/237 (0.84%)  2/243 (0.82%) 
Hypoglycaemia * 1  1/237 (0.42%)  0/243 (0.00%) 
Hyponatraemia * 1  2/237 (0.84%)  0/243 (0.00%) 
Metabolic Acidosis * 1  1/237 (0.42%)  1/243 (0.41%) 
Tumour Lysis Syndrome * 1  0/237 (0.00%)  1/243 (0.41%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/237 (0.00%)  1/243 (0.41%) 
Back Pain * 1  2/237 (0.84%)  1/243 (0.41%) 
Bone Pain * 1  1/237 (0.42%)  2/243 (0.82%) 
Flank Pain * 1  0/237 (0.00%)  1/243 (0.41%) 
Musculoskeletal Chest Pain * 1  0/237 (0.00%)  1/243 (0.41%) 
Neck Pain * 1  1/237 (0.42%)  0/243 (0.00%) 
Osteonecrosis of Jaw * 1  1/237 (0.42%)  0/243 (0.00%) 
Pain in Extremity * 1  2/237 (0.84%)  0/243 (0.00%) 
Pathological Fracture * 1  0/237 (0.00%)  2/243 (0.82%) 
Spinal Pain * 1  1/237 (0.42%)  1/243 (0.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of Colon * 1  0/237 (0.00%)  1/243 (0.41%) 
Breast Cancer * 1  0/237 (0.00%)  1/243 (0.41%) 
Breast Cancer Recurrent * 1  1/237 (0.42%)  0/243 (0.00%) 
Gastrointestinal Tract Adenoma * 1  0/237 (0.00%)  1/243 (0.41%) 
Liposarcoma * 1  0/237 (0.00%)  1/243 (0.41%) 
Plasmacytoma * 1  0/237 (0.00%)  1/243 (0.41%) 
Squamous Cell Carcinoma of Skin * 1  0/237 (0.00%)  1/243 (0.41%) 
Transitional Cell Carcinoma * 1  0/237 (0.00%)  1/243 (0.41%) 
Nervous system disorders     
Cerebral Infarction * 1  0/237 (0.00%)  1/243 (0.41%) 
Cerebrovascular Accident * 1  1/237 (0.42%)  0/243 (0.00%) 
Embolic Stroke * 1  0/237 (0.00%)  1/243 (0.41%) 
Headache * 1  0/237 (0.00%)  1/243 (0.41%) 
Ischaemic Stroke * 1  0/237 (0.00%)  2/243 (0.82%) 
Monoparesis * 1  1/237 (0.42%)  0/243 (0.00%) 
Radicular Syndrome * 1  0/237 (0.00%)  1/243 (0.41%) 
Restless Legs Syndrome * 1  1/237 (0.42%)  0/243 (0.00%) 
Syncope * 1  2/237 (0.84%)  1/243 (0.41%) 
Transient Ischaemic Attack * 1  0/237 (0.00%)  1/243 (0.41%) 
Vith Nerve Paralysis * 1  0/237 (0.00%)  1/243 (0.41%) 
Psychiatric disorders     
Confusional State * 1  0/237 (0.00%)  1/243 (0.41%) 
Depressed Mood * 1  0/237 (0.00%)  1/243 (0.41%) 
Depression * 1  1/237 (0.42%)  0/243 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  1/237 (0.42%)  3/243 (1.23%) 
Chronic Kidney Disease * 1  1/237 (0.42%)  1/243 (0.41%) 
Haematuria * 1  0/237 (0.00%)  1/243 (0.41%) 
Myeloma Cast Nephropathy * 1  1/237 (0.42%)  0/243 (0.00%) 
Renal Impairment * 1  0/237 (0.00%)  1/243 (0.41%) 
Urinary Retention * 1  1/237 (0.42%)  0/243 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/237 (0.00%)  1/243 (0.41%) 
Chronic Obstructive Pulmonary Disease * 1  1/237 (0.42%)  1/243 (0.41%) 
Epistaxis * 1  0/237 (0.00%)  2/243 (0.82%) 
Hydrothorax * 1  0/237 (0.00%)  1/243 (0.41%) 
Hyperventilation * 1  0/237 (0.00%)  1/243 (0.41%) 
Laryngeal Oedema * 1  0/237 (0.00%)  1/243 (0.41%) 
Organising Pneumonia * 1  0/237 (0.00%)  1/243 (0.41%) 
Oropharyngeal Swelling * 1  0/237 (0.00%)  1/243 (0.41%) 
Pleural Effusion * 1  0/237 (0.00%)  2/243 (0.82%) 
Pneumonia Aspiration * 1  0/237 (0.00%)  1/243 (0.41%) 
Pulmonary Alveolar Haemorrhage * 1  1/237 (0.42%)  0/243 (0.00%) 
Pulmonary Artery Thrombosis * 1  0/237 (0.00%)  1/243 (0.41%) 
Pulmonary Embolism * 1  2/237 (0.84%)  1/243 (0.41%) 
Pulmonary Haemorrhage * 1  0/237 (0.00%)  1/243 (0.41%) 
Pulmonary Oedema * 1  1/237 (0.42%)  0/243 (0.00%) 
Respiratory Failure * 1  2/237 (0.84%)  2/243 (0.82%) 
Vascular disorders     
Hypertension * 1  0/237 (0.00%)  1/243 (0.41%) 
Hypertensive Crisis * 1  0/237 (0.00%)  1/243 (0.41%) 
Orthostatic Hypotension * 1  2/237 (0.84%)  0/243 (0.00%) 
Peripheral Artery Aneurysm * 1  0/237 (0.00%)  1/243 (0.41%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bortezomib + Dexamethasone (Vd) Daratumumab + Bortezomib and Dexamethasone (DVd)
Affected / at Risk (%) Affected / at Risk (%)
Total   224/237 (94.51%)   238/243 (97.94%) 
Blood and lymphatic system disorders     
Anaemia * 1  74/237 (31.22%)  58/243 (23.87%) 
Leukopenia * 1  11/237 (4.64%)  19/243 (7.82%) 
Lymphopenia * 1  9/237 (3.80%)  32/243 (13.17%) 
Neutropenia * 1  22/237 (9.28%)  42/243 (17.28%) 
Thrombocytopenia * 1  104/237 (43.88%)  143/243 (58.85%) 
Gastrointestinal disorders     
Abdominal Pain Upper * 1  7/237 (2.95%)  13/243 (5.35%) 
Constipation * 1  36/237 (15.19%)  48/243 (19.75%) 
Diarrhoea * 1  53/237 (22.36%)  76/243 (31.28%) 
Dyspepsia * 1  13/237 (5.49%)  5/243 (2.06%) 
Nausea * 1  26/237 (10.97%)  34/243 (13.99%) 
Vomiting * 1  9/237 (3.80%)  26/243 (10.70%) 
General disorders     
Asthenia * 1  36/237 (15.19%)  21/243 (8.64%) 
Fatigue * 1  58/237 (24.47%)  52/243 (21.40%) 
Oedema * 1  9/237 (3.80%)  14/243 (5.76%) 
Oedema Peripheral * 1  19/237 (8.02%)  40/243 (16.46%) 
Pyrexia * 1  25/237 (10.55%)  35/243 (14.40%) 
Infections and infestations     
Bronchitis * 1  12/237 (5.06%)  26/243 (10.70%) 
Conjunctivitis * 1  7/237 (2.95%)  21/243 (8.64%) 
Herpes Zoster * 1  5/237 (2.11%)  13/243 (5.35%) 
Nasopharyngitis * 1  9/237 (3.80%)  17/243 (7.00%) 
Pneumonia * 1  7/237 (2.95%)  17/243 (7.00%) 
Upper Respiratory Tract Infection * 1  41/237 (17.30%)  57/243 (23.46%) 
Investigations     
Alanine Aminotransferase Increased * 1  10/237 (4.22%)  17/243 (7.00%) 
Weight Decreased * 1  3/237 (1.27%)  13/243 (5.35%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  12/237 (5.06%)  22/243 (9.05%) 
Hyperglycaemia * 1  17/237 (7.17%)  19/243 (7.82%) 
Hypokalaemia * 1  11/237 (4.64%)  22/243 (9.05%) 
Hypophosphataemia * 1  7/237 (2.95%)  13/243 (5.35%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  11/237 (4.64%)  22/243 (9.05%) 
Back Pain * 1  24/237 (10.13%)  32/243 (13.17%) 
Bone Pain * 1  13/237 (5.49%)  13/243 (5.35%) 
Muscle Spasms * 1  5/237 (2.11%)  19/243 (7.82%) 
Musculoskeletal Chest Pain * 1  5/237 (2.11%)  15/243 (6.17%) 
Pain in Extremity * 1  15/237 (6.33%)  22/243 (9.05%) 
Nervous system disorders     
Dizziness * 1  24/237 (10.13%)  24/243 (9.88%) 
Headache * 1  14/237 (5.91%)  24/243 (9.88%) 
Neuralgia * 1  26/237 (10.97%)  33/243 (13.58%) 
Paraesthesia * 1  14/237 (5.91%)  11/243 (4.53%) 
Peripheral Sensory Neuropathy * 1  89/237 (37.55%)  115/243 (47.33%) 
Psychiatric disorders     
Insomnia * 1  35/237 (14.77%)  41/243 (16.87%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  1/237 (0.42%)  23/243 (9.47%) 
Cough * 1  30/237 (12.66%)  58/243 (23.87%) 
Dyspnoea * 1  21/237 (8.86%)  45/243 (18.52%) 
Epistaxis * 1  12/237 (5.06%)  11/243 (4.53%) 
Skin and subcutaneous tissue disorders     
Rash * 1  7/237 (2.95%)  13/243 (5.35%) 
Vascular disorders     
Hypertension * 1  8/237 (3.38%)  21/243 (8.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Janssen R&D US
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02136134     History of Changes
Obsolete Identifiers: NCT01620879
Other Study ID Numbers: CR103995
2014-000255-85 ( EudraCT Number )
54767414MMY3004 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: May 1, 2014
First Posted: May 12, 2014
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: September 24, 2018