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Study of Vorinostat (MK0683), an Histone Deacetylase (HDAC) Inhibitor in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (MK-0683-095)

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ClinicalTrials.gov Identifier: NCT00773838
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsed or Refractory Multiple Myeloma
Interventions Drug: Vorinostat
Drug: Bortezomib
Drug: Dexamethasone
Enrollment 143
Recruitment Details  
Pre-assignment Details Of 143 participants enrolled, 142 participants were allocated to treatment. Five participants received additional treatment for about 1 year during an extension as per investigator's discretion based on clinical benefit of the treatment received. All 5 participants discontinued extension treatment and were followed for survival up to 2 years post last dose of treatment.
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Period Title: Overall Study
Started 143
Completed 0
Not Completed 143
Reason Not Completed
Adverse Event             29
Lost to Follow-up             1
Physician Decision             8
Progressive Disease             82
Protocol Violation             2
Withdrawal by Subject             21
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Baseline Participants 143
Hide Baseline Analysis Population Description
All allocated participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 143 participants
62.1  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants
Female
56
  39.2%
Male
87
  60.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants
Hispanic or Latino
5
   3.5%
Not Hispanic or Latino
138
  96.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 143 participants
American Indian or Alaska Native
0
   0.0%
Asian
34
  23.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
   4.9%
White
102
  71.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Objective Response Rate (RR)
Hide Description Objective RR was defined as percentage (%) of participants with complete response (CR: disappearance of original monoclonal (M) paraprotein from blood & urine on at least 2 determinations for at least 6 weeks (WKs) by immunofixation studies, <5% plasma cells in bone marrow on at least 1 determination, no increase in size/number of lytic bone lesions (LBLs) & disappearance of soft tissue plasmacytomas (STP) for at least 6 WKs on skeletal survey (SS) if available) or partial response (PR: ≥50% reduction in serum M protein for at least 2 determinations 6 WKs apart, if present, reduction in 24-hour urinary light chain excretion by ≥90% or ≤200 mg for at least 2 determinations 6 WKs apart, ≥50% reduction in STP size for at least 6 WKs, & no increase in size/number of LBLs on SS if available) as assessed by Independent Adjudication Committee (IAC) per European Blood & Marrow Transplant (EBMT) criteria. To report RR & 95% confidence intervals (CIs), exact test of binomial parameter was used.
Time Frame Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:
Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Participants Analyzed 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
11.3
(6.6 to 17.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vorinostat + Bortezomib
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.419
Comments [Not Specified]
Method Exact Test for Binomial Parameter
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Experienced an Adverse Event (AE)
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE were reported.
Time Frame Up to approximately 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:
Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Participants Analyzed 142
Measure Type: Count of Participants
Unit of Measure: Participants
142
 100.0%
3.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to an AE
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE were reported.
Time Frame Up to approximately 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:
Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Participants Analyzed 142
Measure Type: Count of Participants
Unit of Measure: Participants
28
  19.7%
4.Secondary Outcome
Title Time To Disease Progression (TTP) as Determined by IAC Per EBMT Criteria
Hide Description TTP was defined as the time from allocation to the first documented disease progression (PD) as determined by IAC per EBMT criteria or death due to myeloma, whichever occurred first. PD: >25% increase in level of serum Mparaprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median TTP (in months) and associated 95% CIs Kaplan-Meier method was used.
Time Frame Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:
Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: Months
3.47
(2.53 to 4.57)
5.Secondary Outcome
Title TTP as Assessed by Investigator Per EBMT Criteria
Hide Description TTP was defined as the time from allocation to the first documented PD as assessed by investigator per EBMT criteria or death due to myeloma, whichever occurred first. PD: >25% increase in level of serum Mparaprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median TTP (in months) and associated 95% CIs Kaplan-Meier method was used.
Time Frame Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:
Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: Months
3.07
(2.37 to 4.33)
6.Secondary Outcome
Title Progression-Free Survival (PFS) as Determined by IAC Per EBMT Criteria
Hide Description PFS was defined as the time from allocation to the first documents PD as determined by IAC per EBMT criteria or death due to any cause, whichever occurs first. PD: >25% increase in level of serum M-paraprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median PFS (in months) and associated 95%CIs Kaplan-Meier method was used.
Time Frame Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:
Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: Months
3.13
(2.40 to 4.33)
7.Secondary Outcome
Title PFS as Assessed by Investigator Per EBMT Criteria
Hide Description PFS was defined as the time from allocation to the first documents PD as assessed by investigator per EBMT criteria or death due to any cause, whichever occurs first. PD: >25% increase in level of serum M-paraprotein, which must also be an absolute increase of at least 5g/L (500 mg/dL) and confirmed on a repeat investigation or 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg/24hour and confirmed on a repeat investigation or >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10% or definitive increase in size of existing LBLs or STP or development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause). To report the median PFS (in months) and associated 95%CIs Kaplan-Meier method was used.
Time Frame Up to approximately 30 months (through Final Analysis data cut-off of 16-May-2011)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:
Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Participants Analyzed 142
Median (95% Confidence Interval)
Unit of Measure: Months
2.83
(2.17 to 3.77)
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from allocation to death due to any cause. To report the median survival (in months) and the associated 95%CIs were reported using Kaplan-Meier method was used. Participants without documented death at the time of final analysis were censored at the date of the last follow up.
Time Frame Up to approximately 40 months (through End of Trial data cut-off of 09-Apr-2012)
Hide Outcome Measure Data
Hide Analysis Population Description
All allocated participants
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description:
Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Overall Number of Participants Analyzed 143
Median (95% Confidence Interval)
Unit of Measure: Months
11.23
(8.47 to 14.43)
Time Frame Up tp approximately 22 months for non-serious adverse events (AEs). Up to approximately 40 months for serious AEs and all-cause mortality.
Adverse Event Reporting Description All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all enrolled participants who received at least 1 dose of study treatment. Only serious AEs were collected for participants treated on extension.
 
Arm/Group Title Vorinostat + Bortezomib
Hide Arm/Group Description Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
All-Cause Mortality
Vorinostat + Bortezomib
Affected / at Risk (%)
Total   85/143 (59.44%)    
Hide Serious Adverse Events
Vorinostat + Bortezomib
Affected / at Risk (%) # Events
Total   92/142 (64.79%)    
Blood and lymphatic system disorders   
Anaemia  1  4/142 (2.82%)  4
Febrile neutropenia  1  3/142 (2.11%)  3
Hyperviscosity syndrome  1  1/142 (0.70%)  1
Lymphadenitis  1  1/142 (0.70%)  1
Pancytopenia  1  1/142 (0.70%)  1
Thrombocytopenia  1  6/142 (4.23%)  6
Cardiac disorders   
Acute myocardial infarction  1  1/142 (0.70%)  1
Angina unstable  1  1/142 (0.70%)  2
Cardiac failure  1  1/142 (0.70%)  1
Myocardial ischaemia  1  1/142 (0.70%)  1
Sinus tachycardia  1  1/142 (0.70%)  1
Tachycardia  1  1/142 (0.70%)  1
Ear and labyrinth disorders   
Deafness neurosensory  1  1/142 (0.70%)  1
Endocrine disorders   
Inappropriate antidiuretic hormone secretion  1  1/142 (0.70%)  1
Eye disorders   
Blepharitis  1  1/142 (0.70%)  1
Cataract  1  1/142 (0.70%)  1
Conjunctivitis  1  1/142 (0.70%)  1
Gastrointestinal disorders   
Diarrhoea  1  8/142 (5.63%)  8
Gingival bleeding  1  1/142 (0.70%)  1
Inguinal hernia  1  1/142 (0.70%)  1
Nausea  1  2/142 (1.41%)  3
Vomiting  1  1/142 (0.70%)  1
General disorders   
Asthenia  1  6/142 (4.23%)  6
Fatigue  1  1/142 (0.70%)  1
Mucosal inflammation  1  1/142 (0.70%)  1
Oedema  1  1/142 (0.70%)  1
Pain  1  1/142 (0.70%)  1
Pyrexia  1  7/142 (4.93%)  7
Immune system disorders   
Immunodeficiency  1  1/142 (0.70%)  1
Infections and infestations   
Appendicitis  1  1/142 (0.70%)  1
Bacteraemia  1  1/142 (0.70%)  1
Bacterial sepsis  1  1/142 (0.70%)  1
Bronchitis  1  1/142 (0.70%)  1
Bronchopneumonia  1  1/142 (0.70%)  1
Device related infection  1  1/142 (0.70%)  1
Febrile infection  1  1/142 (0.70%)  1
Gastroenteritis  1  2/142 (1.41%)  2
Gastrointestinal infection  1  1/142 (0.70%)  1
H1N1 influenza  1  1/142 (0.70%)  1
Herpes zoster  1  1/142 (0.70%)  1
Lobar pneumonia  1  1/142 (0.70%)  1
Lower respiratory tract infection  1  3/142 (2.11%)  3
Lung infection  1  2/142 (1.41%)  2
Pharyngotonsillitis  1  1/142 (0.70%)  1
Pneumocystis jiroveci pneumonia  1  2/142 (1.41%)  2
Pneumonia  1  13/142 (9.15%)  14
Pneumonia respiratory syncytial viral  1  1/142 (0.70%)  1
Pyelonephritis acute  1  1/142 (0.70%)  1
Respiratory tract infection  1  1/142 (0.70%)  1
Sepsis  1  5/142 (3.52%)  5
Septic shock  1  2/142 (1.41%)  2
Staphylococcal infection  1  1/142 (0.70%)  1
Streptococcal bacteraemia  1  1/142 (0.70%)  1
Upper respiratory tract infection  1  2/142 (1.41%)  2
Urinary tract infection  1  2/142 (1.41%)  2
Urosepsis  1  1/142 (0.70%)  1
Injury, poisoning and procedural complications   
Accidental overdose  1  12/142 (8.45%)  15
Contusion  1  1/142 (0.70%)  1
Femur fracture  1  1/142 (0.70%)  1
Head injury  1  1/142 (0.70%)  1
Heat stroke  1  1/142 (0.70%)  1
Intentional overdose  1  1/142 (0.70%)  1
Rib fracture  1  1/142 (0.70%)  1
Upper limb fracture  1  1/142 (0.70%)  1
Investigations   
Blood creatinine increased  1  1/142 (0.70%)  3
Metabolism and nutrition disorders   
Dehydration  1  1/142 (0.70%)  1
Hypercalcaemia  1  2/142 (1.41%)  2
Hypokalaemia  1  1/142 (0.70%)  1
Hyponatraemia  1  2/142 (1.41%)  2
Malnutrition  1  1/142 (0.70%)  1
Metabolic acidosis  1  1/142 (0.70%)  1
Tumour lysis syndrome  1  1/142 (0.70%)  1
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/142 (0.70%)  1
Back pain  1  1/142 (0.70%)  1
Bone pain  1  1/142 (0.70%)  1
Joint range of motion decreased  1  1/142 (0.70%)  1
Muscular weakness  1  1/142 (0.70%)  2
Musculoskeletal chest pain  1  1/142 (0.70%)  1
Neck pain  1  1/142 (0.70%)  1
Pathological fracture  1  1/142 (0.70%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  1/142 (0.70%)  1
Neoplasm malignant  1  30/142 (21.13%)  31
Nervous system disorders   
Altered state of consciousness  1  1/142 (0.70%)  1
Cerebral haemorrhage  1  1/142 (0.70%)  1
Convulsion  1  1/142 (0.70%)  1
Dizziness  1  1/142 (0.70%)  1
Nerve root compression  1  1/142 (0.70%)  1
Post herpetic neuralgia  1  1/142 (0.70%)  1
Psychiatric disorders   
Delirium  1  1/142 (0.70%)  1
Renal and urinary disorders   
Haematuria  1  1/142 (0.70%)  1
Neurogenic bladder  1  1/142 (0.70%)  1
Renal failure  1  2/142 (1.41%)  2
Renal failure acute  1  10/142 (7.04%)  12
Renal failure chronic  1  1/142 (0.70%)  1
Urinary retention  1  1/142 (0.70%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/142 (0.70%)  1
Chronic obstructive pulmonary disease  1  1/142 (0.70%)  1
Epistaxis  1  1/142 (0.70%)  1
Hypoxia  1  1/142 (0.70%)  1
Pleural effusion  1  2/142 (1.41%)  2
Pulmonary embolism  1  1/142 (0.70%)  1
Pulmonary oedema  1  2/142 (1.41%)  2
Vascular disorders   
Thrombosis  1  1/142 (0.70%)  1
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vorinostat + Bortezomib
Affected / at Risk (%) # Events
Total   140/142 (98.59%)    
Blood and lymphatic system disorders   
Anaemia  1  74/142 (52.11%)  231
Leukopenia  1  25/142 (17.61%)  74
Neutropenia  1  53/142 (37.32%)  135
Thrombocytopenia  1  99/142 (69.72%)  582
Eye disorders   
Vision blurred  1  11/142 (7.75%)  13
Gastrointestinal disorders   
Abdominal discomfort  1  8/142 (5.63%)  9
Abdominal pain  1  18/142 (12.68%)  25
Abdominal pain upper  1  12/142 (8.45%)  18
Constipation  1  35/142 (24.65%)  47
Diarrhoea  1  74/142 (52.11%)  189
Dry mouth  1  10/142 (7.04%)  10
Dyspepsia  1  11/142 (7.75%)  16
Nausea  1  80/142 (56.34%)  162
Vomiting  1  53/142 (37.32%)  103
General disorders   
Asthenia  1  31/142 (21.83%)  57
Chest pain  1  13/142 (9.15%)  15
Chills  1  12/142 (8.45%)  14
Fatigue  1  69/142 (48.59%)  143
Oedema peripheral  1  17/142 (11.97%)  18
Pyrexia  1  34/142 (23.94%)  56
Infections and infestations   
Nasopharyngitis  1  14/142 (9.86%)  19
Upper respiratory tract infection  1  17/142 (11.97%)  23
Injury, poisoning and procedural complications   
Contusion  1  10/142 (7.04%)  12
Investigations   
Blood creatinine increased  1  18/142 (12.68%)  31
Platelet count decreased  1  15/142 (10.56%)  48
Weight decreased  1  13/142 (9.15%)  21
Metabolism and nutrition disorders   
Decreased appetite  1  53/142 (37.32%)  78
Dehydration  1  11/142 (7.75%)  11
Hypoalbuminaemia  1  10/142 (7.04%)  13
Hypokalaemia  1  15/142 (10.56%)  27
Hyponatraemia  1  11/142 (7.75%)  19
Musculoskeletal and connective tissue disorders   
Arthralgia  1  13/142 (9.15%)  16
Back pain  1  19/142 (13.38%)  26
Bone pain  1  8/142 (5.63%)  14
Muscle spasms  1  12/142 (8.45%)  17
Musculoskeletal chest pain  1  10/142 (7.04%)  11
Musculoskeletal pain  1  13/142 (9.15%)  15
Myalgia  1  11/142 (7.75%)  12
Pain in extremity  1  18/142 (12.68%)  22
Nervous system disorders   
Dizziness  1  21/142 (14.79%)  26
Headache  1  25/142 (17.61%)  35
Neuralgia  1  14/142 (9.86%)  17
Neuropathy peripheral  1  17/142 (11.97%)  27
Peripheral sensory neuropathy  1  8/142 (5.63%)  14
Psychiatric disorders   
Insomnia  1  13/142 (9.15%)  14
Respiratory, thoracic and mediastinal disorders   
Cough  1  27/142 (19.01%)  31
Dyspnoea  1  33/142 (23.24%)  56
Epistaxis  1  23/142 (16.20%)  36
Oropharyngeal pain  1  8/142 (5.63%)  9
Productive cough  1  8/142 (5.63%)  10
Vascular disorders   
Haematoma  1  8/142 (5.63%)  10
Hypertension  1  13/142 (9.15%)  17
Hypotension  1  14/142 (9.86%)  16
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
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 Sponsor have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00773838    
Other Study ID Numbers: 0683-095
2008-003753-33 ( EudraCT Number )
MK-0683-095 ( Other Identifier: Merck )
2008_524 ( Other Identifier: Merck )
First Submitted: October 14, 2008
First Posted: October 16, 2008
Results First Submitted: March 5, 2021
Results First Posted: April 1, 2021
Last Update Posted: April 1, 2021