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A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02076009
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Results First Posted : February 10, 2017
Last Update Posted : April 2, 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: Lenalidomide
Drug: Dexamethasone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Participant Flow:   Overall Study
    Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd)
STARTED   283   286 
Treated   281   283 
COMPLETED   0   0 
NOT COMPLETED   283   286 
Death                44                30 
Withdrawal by Subject                9                3 
Lost to Follow-up                1                1 
Progressive disease                1                0 
Ongoing                226                249 
Subjects randomized but not treated                2                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Total Total of all reporting groups

Baseline Measures
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd)   Total 
Overall Participants Analyzed 
[Units: Participants]
 283   286   569 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (8.84)   64.4  (9.03)   64.4  (8.93) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      119  42.0%      113  39.5%      232  40.8% 
Male      164  58.0%      173  60.5%      337  59.2% 
Region of Enrollment 
[Units: Participants]
     
Australia   9   9   18 
Belgium   10   12   22 
Canada   17   17   34 
Denmark   7   10   17 
France   36   21   57 
Germany   7   11   18 
Greece   8   11   19 
Israel   20   19   39 
Japan   15   21   36 
Korea, Republic of   20   20   40 
Netherlands   3   1   4 
Poland   13   15   28 
Russian Federation   30   18   48 
Spain   25   26   51 
Sweden   15   16   31 
Taiwan, Province of China   9   11   20 
United Kingdom   24   27   51 
United States   15   21   36 
Stage of Disease (ISS) [1] 
[Units: Participants]
     
 140   137   277 
II   86   93   179 
III   57   56   113 
[1] 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 
[Units: Participants]
     
 146   149   295 
 80   85   165 
 38   38   76 
>3   19   14   33 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization to either disease progression or death whichever occurs first until 3 years ]

2.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: From randomization to disease progression until 3 years ]

3.  Secondary:   Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better   [ Time Frame: From randomization to disease progression (approximately up to 3 years) ]

4.  Secondary:   Percentage of Participants With Negative Minimal Residual Disease (MRD)   [ Time Frame: From randomization to the date of first documented evidence of PD until 3 years ]

5.  Secondary:   Overall Response Rate   [ Time Frame: From randomization to disease progression (approximately up to 3 years) ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to approximately 5 years (anticipated) after the last participant is randomized ]

7.  Secondary:   Time to Response   [ Time Frame: From randomization up to first documented CR or PR until 3 years ]

8.  Secondary:   Duration of Response (DOR)   [ Time Frame: From randomization to the date of first documented evidence of PD until 3 years ]


  Serious Adverse Events

Time Frame No text entered.
Additional Description Safety Population included participants who were randomized and received at least 1 dose of any study treatment.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Serious Adverse Events
    Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd)
Total, Serious Adverse Events     
# participants affected / at risk   118/281 (41.99%)   138/283 (48.76%) 
Blood and lymphatic system disorders     
Anaemia * 1     
# participants affected / at risk   2/281 (0.71%)   2/283 (0.71%) 
Bone Marrow Failure * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Febrile Neutropenia * 1     
# participants affected / at risk   4/281 (1.42%)   12/283 (4.24%) 
Hyperviscosity Syndrome * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Lymphadenopathy * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Neutropenia * 1     
# participants affected / at risk   0/281 (0.00%)   2/283 (0.71%) 
Sideroblastic Anaemia * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Thrombocytopenia * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Thrombotic Thrombocytopenic Purpura * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Cardiac disorders     
Acute Coronary Syndrome * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Acute Myocardial Infarction * 1     
# participants affected / at risk   3/281 (1.07%)   0/283 (0.00%) 
Angina Pectoris * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Atrial Fibrillation * 1     
# participants affected / at risk   2/281 (0.71%)   2/283 (0.71%) 
Atrial Flutter * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Cardiac Amyloidosis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Cardiac Arrest * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Cardiac Failure Congestive * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Cardiopulmonary Failure * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Myocardial Infarction * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Pericarditis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Sinus Arrhythmia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Supraventricular Tachycardia * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Eye disorders     
Cataract * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Posterior Capsule Rupture * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Gastrointestinal disorders     
Colitis * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Constipation * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Diarrhoea * 1     
# participants affected / at risk   6/281 (2.14%)   5/283 (1.77%) 
Diverticular Perforation * 1     
# participants affected / at risk   0/281 (0.00%)   2/283 (0.71%) 
Gastrointestinal Angiodysplasia Haemorrhagic * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Gastrointestinal Disorder * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Haematemesis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Inguinal Hernia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Intestinal Obstruction * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Lower Gastrointestinal Haemorrhage * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Nausea * 1     
# participants affected / at risk   0/281 (0.00%)   2/283 (0.71%) 
Oesophagitis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Vomiting * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
General disorders     
Asthenia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Chest Discomfort * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Fatigue * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Gait Disturbance * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
General Physical Health Deterioration * 1     
# participants affected / at risk   0/281 (0.00%)   2/283 (0.71%) 
Generalised Oedema * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Multi-Organ Failure * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Non-Cardiac Chest Pain * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Pain * 1     
# participants affected / at risk   2/281 (0.71%)   1/283 (0.35%) 
Pyrexia * 1     
# participants affected / at risk   4/281 (1.42%)   8/283 (2.83%) 
Systemic Inflammatory Response Syndrome * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Hepatobiliary disorders     
Bile Duct Stone * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Liver Disorder * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Infections and infestations     
Acute Sinusitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Anal Abscess * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Appendicitis * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Bacterial Infection * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Bronchiolitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Bronchitis * 1     
# participants affected / at risk   4/281 (1.42%)   5/283 (1.77%) 
Bronchitis Bacterial * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Bronchopneumonia * 1     
# participants affected / at risk   0/281 (0.00%)   2/283 (0.71%) 
Candida Infection * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Cellulitis * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Clostridium Difficile Infection * 1     
# participants affected / at risk   2/281 (0.71%)   0/283 (0.00%) 
Cytomegalovirus Infection * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Enterocolitis Infectious * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Epiglottitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Erysipelas * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Escherichia Bacteraemia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Extradural Abscess * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Gastroenteritis * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Gastroenteritis Viral * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Gastrointestinal Infection * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Gingivitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
H1n1 Influenza * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Haemophilus Infection * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Infection * 1     
# participants affected / at risk   3/281 (1.07%)   2/283 (0.71%) 
Infective Spondylitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Influenza * 1     
# participants affected / at risk   4/281 (1.42%)   8/283 (2.83%) 
Keratitis Fungal * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Listeria Sepsis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Lobar Pneumonia * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Lower Respiratory Tract Infection * 1     
# participants affected / at risk   3/281 (1.07%)   7/283 (2.47%) 
Lung Infection * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Nasal Abscess * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Necrotising Fasciitis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Neutropenic Sepsis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Oral Fungal Infection * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Osteomyelitis * 1     
# participants affected / at risk   2/281 (0.71%)   0/283 (0.00%) 
Parainfluenzae Virus Infection * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Parotitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Periorbital Cellulitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Pharyngitis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Pneumonia * 1     
# participants affected / at risk   24/281 (8.54%)   23/283 (8.13%) 
Pneumonia Bacterial * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Pneumonia Haemophilus * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Pneumonia Influenzal * 1     
# participants affected / at risk   0/281 (0.00%)   3/283 (1.06%) 
Pneumonia Klebsiella * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Pneumonia Legionella * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Pneumonia Streptococcal * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Pulmonary Tuberculosis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Pyelonephritis Acute * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Respiratory Syncytial Virus Infection * 1     
# participants affected / at risk   0/281 (0.00%)   2/283 (0.71%) 
Respiratory Tract Infection * 1     
# participants affected / at risk   2/281 (0.71%)   5/283 (1.77%) 
Respiratory Tract Infection Viral * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Salmonella Bacteraemia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Sepsis * 1     
# participants affected / at risk   5/281 (1.78%)   2/283 (0.71%) 
Septic Shock * 1     
# participants affected / at risk   1/281 (0.36%)   3/283 (1.06%) 
Skin Infection * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Soft Tissue Infection * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Tonsillitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Upper Respiratory Tract Infection * 1     
# participants affected / at risk   5/281 (1.78%)   1/283 (0.35%) 
Upper Respiratory Tract Infection Bacterial * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Urinary Tract Infection * 1     
# participants affected / at risk   1/281 (0.36%)   3/283 (1.06%) 
Urosepsis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Uterine Abscess * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Varicella Zoster Virus Infection * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Viral Infection * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Injury, poisoning and procedural complications     
Compression Fracture * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Fall * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Femoral Neck Fracture * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Foot Fracture * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Hand Fracture * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Hip Fracture * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Humerus Fracture * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Joint Dislocation * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Pelvic Fracture * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Peroneal Nerve Injury * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Radius Fracture * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Rib Fracture * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Spinal Compression Fracture * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Subdural Haematoma * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Investigations     
Body Temperature Increased * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Diagnostic Procedure * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
International Normalised Ratio Increased * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Troponin Increased * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Dehydration * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Electrolyte Imbalance * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Gout * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Hypercalcaemia * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Hyperglycaemia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Hypocalcaemia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1     
# participants affected / at risk   5/281 (1.78%)   2/283 (0.71%) 
Bone Pain * 1     
# participants affected / at risk   0/281 (0.00%)   2/283 (0.71%) 
Flank Pain * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Intervertebral Disc Protrusion * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Muscular Weakness * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Musculoskeletal Pain * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Osteonecrosis of Jaw * 1     
# participants affected / at risk   2/281 (0.71%)   0/283 (0.00%) 
Pain in Extremity * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Pathological Fracture * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Spinal Column Stenosis * 1     
# participants affected / at risk   2/281 (0.71%)   0/283 (0.00%) 
Spinal Pain * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Monocytic Leukaemia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Benign Anorectal Neoplasm * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Bladder Transitional Cell Carcinoma * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Bowen's Disease * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Epstein-Barr Virus Associated Lymphoproliferative Disorder * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Lung Adenocarcinoma * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Plasma Cell Leukaemia * 1     
# participants affected / at risk   2/281 (0.71%)   1/283 (0.35%) 
Prostate Cancer * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Rectal Adenocarcinoma * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Squamous Cell Carcinoma * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Nervous system disorders     
Aphasia * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Carotid Arteriosclerosis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Cerebral Haemorrhage * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Cerebral Infarction * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Cognitive Disorder * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Intercostal Neuralgia * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Ischaemic Stroke * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Loss of Consciousness * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Nervous System Disorder * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Peripheral Sensory Neuropathy * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Presyncope * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Seizure * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Somnolence * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Syncope * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Transient Ischaemic Attack * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Trigeminal Nerve Disorder * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Viith Nerve Paralysis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Psychiatric disorders     
Confusional State * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Depression * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Depressive Symptom * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1     
# participants affected / at risk   8/281 (2.85%)   3/283 (1.06%) 
Azotaemia * 1     
# participants affected / at risk   1/281 (0.36%)   1/283 (0.35%) 
Renal Failure * 1     
# participants affected / at risk   3/281 (1.07%)   1/283 (0.35%) 
Urethral Haemorrhage * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Reproductive system and breast disorders     
Prostatomegaly * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Acute Respiratory Failure * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Bronchospasm * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Dyspnoea * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Hypoxia * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Interstitial Lung Disease * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Lung Disorder * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Pneumonitis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Pneumothorax * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Pulmonary Calcification * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Pulmonary Embolism * 1     
# participants affected / at risk   8/281 (2.85%)   7/283 (2.47%) 
Pulmonary Oedema * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Respiratory Failure * 1     
# participants affected / at risk   1/281 (0.36%)   2/283 (0.71%) 
Skin and subcutaneous tissue disorders     
Rash Generalised * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Rash Papular * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Vascular disorders     
Deep Vein Thrombosis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Embolism * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Haemorrhagic Infarction * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Hypertension * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Hypotension * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Orthostatic Hypotension * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Peripheral Artery Stenosis * 1     
# participants affected / at risk   0/281 (0.00%)   1/283 (0.35%) 
Phlebitis * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
Venous Occlusion * 1     
# participants affected / at risk   1/281 (0.36%)   0/283 (0.00%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA Version 18.0




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02076009     History of Changes
Other Study ID Numbers: CR103663
54767414MMY3003 ( Other Identifier: Janssen Research & Development, LLC )
2013-005525-23 ( EudraCT Number )
First Submitted: February 27, 2014
First Posted: March 3, 2014
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: April 2, 2018