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Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00920855
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : September 17, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: bendamustine
Drug: bortezomib
Enrollment 40
Recruitment Details  
Pre-assignment Details Fifty-one patients were screened and forty from 10 U.S. centers were enrolled. Reasons for not enrolling were failed to meet inclusion and/or exclusion criteria (10) and an adverse event (1).
Arm/Group Title Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Hide Arm/Group Description Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles. Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles. Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Period Title: Overall Study
Started 5 4 31
Safety and Efficacy Populations 5 4 31
Completed 0 [1] 1 [1] 9 [1]
Not Completed 5 3 22
Reason Not Completed
Adverse Event             1             1             4
Withdrawal by Subject             2             1             6
Disease progression             2             1             10
Noncompliance to study medication             0             0             1
Response plateau; started maintenance             0             0             1
[1]
completed eight cycles of treatment
Arm/Group Title Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort Total
Hide Arm/Group Description Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles. Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles. Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles. Total of all reporting groups
Overall Number of Baseline Participants 5 4 31 40
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 31 participants 40 participants
62.8  (18.17) 67.0  (9.49) 64.5  (10.68) 64.6  (11.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 31 participants 40 participants
Female
3
  60.0%
2
  50.0%
12
  38.7%
17
  42.5%
Male
2
  40.0%
2
  50.0%
19
  61.3%
23
  57.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 31 participants 40 participants
White 4 4 24 32
Black 1 0 5 6
Asian 0 0 1 1
Other 0 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 4 participants 31 participants 40 participants
5 4 31 40
Body Surface Area (BSA)  
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 5 participants 4 participants 31 participants 40 participants
1.76  (0.234) 1.81  (0.177) 1.90  (0.265) 1.87  (0.254)
1.Primary Outcome
Title Participants With Dose Limiting Toxicity (DLT)
Hide Description

Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle:

  • grade 4 hematologic toxicity without regard for relationship to study drug treatment
  • thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage
  • grade 3 febrile neutropenia
  • grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy
  • any study drug related grade 3 or grade 4 nonhematologic toxicity
  • any drug related death

Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.

Time Frame Day 1 - 28
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Safety population
Arm/Group Title Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Hide Arm/Group Description:
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Overall Number of Participants Analyzed 5 4 31
Measure Type: Number
Unit of Measure: participants
0 0 0
2.Secondary Outcome
Title Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator
Hide Description Overall tumor response is the sum of a complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR). A modified version of the Bladé criteria for response was used. Abbreviated definitions for the response categories can be found in the description of outcome #3.
Time Frame Up to 7.5 months (eight 28-day cycles)
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Efficacy population
Arm/Group Title Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Hide Arm/Group Description:
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Overall Number of Participants Analyzed 5 4 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.0
(5.27 to 85.34)
25.0
(0.63 to 80.59)
51.6
(33.06 to 69.85)
3.Secondary Outcome
Title Participants' Best Tumor Response as Assessed by the Investigator
Hide Description Abbreviated criteria for response categories: CR includes the disappearance of the original monoclonal protein (M-protein) from blood and urine, and <5% plasma cells in the bone marrow, and no increase in size/number of lytic bone lesions, and disappearance of soft tissue plasmacytomas for >=4 weeks. VGPR includes serum and urine M-protein detectable by immunofixation but not electrophoresis, and reduction in 24-hr urinary light chain excretion by <100 mg, and disappearance of soft tissue plasmacytomas for >= 4 weeks, and no increase in size/number of lytic bone lesions. PR includes a >=50% reduction in serum M-protein, and reduction in 24-hr urinary light chain excretion by either >=90% or to <200 mg, and >=50% reduction in size of soft tissue plasmacytomas, and no increase in size/number of lytic bone lesions. MR includes a >=25% and <=49% reduction in serum M-protein. SD does not meet criteria for the other response categories. See outcome #4 for a definition of PD.
Time Frame up to 7.5 months (eight 28-day cycles)
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Efficacy population
Arm/Group Title Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Hide Arm/Group Description:
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Overall Number of Participants Analyzed 5 4 31
Measure Type: Number
Unit of Measure: participants
Complete response (CR) 0 0 1
Very good partial response (VGPR) 0 0 2
Partial response (PR) 1 0 8
Minimal response (MR) 1 1 5
Stable disease (SD) 2 2 13
Progressive disease (PD) 1 1 2
4.Secondary Outcome
Title Kaplan-Meier Estimate for Time to Progression (TTP)
Hide Description

Time to progression was defined as the time from initiation of therapy to progressive disease (PD). PD requires at least one of the following:

  • >25% increase in serum monoclonal paraprotein (which must also be an absolute increase of at least 5 g/L),
  • >25% increase in 24-hour urinary light chain excretion (which must also be an absolute increase of at least 200 mg/24 h),
  • >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%),
  • definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas,
  • the development of new bone lesions or soft tissue plasmacytomas,
  • the development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
Time Frame up to 8.6 months
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Safety population
Arm/Group Title Bendamustine and Bortezomib - Overall
Hide Arm/Group Description:
Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
8.4 [1] 
(4.03 to NA)
[1]
Upper boundary was not estimated due to the limited number of participants with events.
5.Secondary Outcome
Title Kaplan-Meier Estimate for Progression-Free Survival
Hide Description Progression free survival is the time between the date of initiation of therapy to progressive disease (PD) or death from any cause, whichever occurs first. See outcome #4 for a definition of PD.
Time Frame up to 23 months
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Safety population
Arm/Group Title Bendamustine and Bortezomib - Overall
Hide Arm/Group Description:
Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
15.21
(5.22 to 16.63)
6.Secondary Outcome
Title Time to the First Response
Hide Description Time to first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (ie, CR, VGPR, PR, or MR).
Time Frame up to 8.5 months
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Participants who had a response
Arm/Group Title Bendamustine and Bortezomib - Overall
Hide Arm/Group Description:
Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: months
1.9  (1.51)
7.Secondary Outcome
Title Kaplan-Meier Estimate for Duration of Response
Hide Description Duration of response (DR) is defined as the time from the first response to progressive disease (PD). See outcome #4 for a PD definition.
Time Frame up to 8.5 months
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Hide Analysis Population Description
Participants who had a response
Arm/Group Title Bendamustine and Bortezomib - Overall
Hide Arm/Group Description:
Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(6.55 to NA)
[1]
Median and upper boundary were not estimated due to the limited number of participants with events.
8.Secondary Outcome
Title Kaplan-Meier Estimate for Overall Survival (OS)
Hide Description Overall survival is defined as the time from initiation of therapy to death from any cause or last follow-up visit.
Time Frame up to 23 months
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Safety population
Arm/Group Title Bendamustine and Bortezomib - Overall
Hide Arm/Group Description:
Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
17.82 [1] 
(15.83 to NA)
[1]
Upper boundary was not estimated due to the limited number of participants with events.
9.Secondary Outcome
Title Summary of Participants With Adverse Events (AEs)
Hide Description Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.
Time Frame up to 8.5 months. Deaths are reported up to 18 months
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Safety population
Arm/Group Title Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Hide Arm/Group Description:
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Overall Number of Participants Analyzed 5 4 31
Measure Type: Number
Unit of Measure: participants
Any adverse event 5 4 31
Any non-haematologic adverse event 5 4 31
Severe adverse event (grade 3 or 4) 3 3 22
Treatment-related adverse events 4 4 31
Deaths 1 0 5
Serious adverse events 0 1 7
Withdrawn from study due to AE 2 2 5
Time Frame up to 8.5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Hide Arm/Group Description Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles. Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles. Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
All-Cause Mortality
Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   1/4 (25.00%)   7/31 (22.58%) 
Blood and lymphatic system disorders       
Anaemia  1  0/5 (0.00%)  0/4 (0.00%)  1/31 (3.23%) 
Febrile neutropenia  1  0/5 (0.00%)  0/4 (0.00%)  1/31 (3.23%) 
Thrombocytopenia  1  0/5 (0.00%)  0/4 (0.00%)  1/31 (3.23%) 
General disorders       
Pyrexia  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Infections and infestations       
Cystitis  1  0/5 (0.00%)  0/4 (0.00%)  1/31 (3.23%) 
Pneumonia  1  0/5 (0.00%)  1/4 (25.00%)  1/31 (3.23%) 
Sepsis syndrome  1  0/5 (0.00%)  0/4 (0.00%)  1/31 (3.23%) 
Metabolism and nutrition disorders       
Dehydration  1  0/5 (0.00%)  0/4 (0.00%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/5 (0.00%)  0/4 (0.00%)  1/31 (3.23%) 
Musculoskeletal chest pain  1  0/5 (0.00%)  0/4 (0.00%)  1/31 (3.23%) 
Renal and urinary disorders       
Renal failure  1  0/5 (0.00%)  1/4 (25.00%)  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bendamustine 50 mg/m^2 Cohort Bendamustine 70 mg/m^2 Cohort Bendamustine 90 mg/m^2 Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   4/4 (100.00%)   31/31 (100.00%) 
Blood and lymphatic system disorders       
Thrombocytopenia  1  2/5 (40.00%)  3/4 (75.00%)  19/31 (61.29%) 
Febrile neutropenia  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Anaemia  1  0/5 (0.00%)  0/4 (0.00%)  10/31 (32.26%) 
Leukopenia  1  0/5 (0.00%)  0/4 (0.00%)  4/31 (12.90%) 
Lymphopenia  1  0/5 (0.00%)  1/4 (25.00%)  3/31 (9.68%) 
Neutropenia  1  0/5 (0.00%)  3/4 (75.00%)  15/31 (48.39%) 
Cardiac disorders       
Sinus tachycardia  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Endocrine disorders       
Adrenal insufficiency  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Eye disorders       
Eye irritation  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Scleral hyperaemia  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Gastrointestinal disorders       
Constipation  1  2/5 (40.00%)  3/4 (75.00%)  11/31 (35.48%) 
Anal fissure  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Diarrhoea  1  1/5 (20.00%)  2/4 (50.00%)  9/31 (29.03%) 
Nausea  1  1/5 (20.00%)  3/4 (75.00%)  21/31 (67.74%) 
Abdominal distension  1  0/5 (0.00%)  1/4 (25.00%)  2/31 (6.45%) 
Abdominal pain  1  0/5 (0.00%)  0/4 (0.00%)  4/31 (12.90%) 
Abdominal pain upper  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Gastrooesophageal reflux disease  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Vomiting  1  0/5 (0.00%)  1/4 (25.00%)  10/31 (32.26%) 
General disorders       
Fatigue  1  3/5 (60.00%)  4/4 (100.00%)  17/31 (54.84%) 
Infusion site irritation  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Local swelling  1  1/5 (20.00%)  0/4 (0.00%)  1/31 (3.23%) 
Catheter site pain  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Chest pain  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Chills  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Influenza like illness  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Oedema peripheral  1  0/5 (0.00%)  1/4 (25.00%)  5/31 (16.13%) 
Pain  1  0/5 (0.00%)  1/4 (25.00%)  2/31 (6.45%) 
Pyrexia  1  0/5 (0.00%)  0/4 (0.00%)  6/31 (19.35%) 
Infections and infestations       
Escherichia urinary tract infection  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Influenza  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Nail bed infection  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Skin infection  1  1/5 (20.00%)  0/4 (0.00%)  1/31 (3.23%) 
Upper respiratory tract infection  1  1/5 (20.00%)  1/4 (25.00%)  9/31 (29.03%) 
Catheter site cellulitis  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Gastrointestinal bacterial infection  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Herpes zoster  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Nasopharyngitis  1  0/5 (0.00%)  0/4 (0.00%)  6/31 (19.35%) 
Pneumonia  1  0/5 (0.00%)  1/4 (25.00%)  2/31 (6.45%) 
Sinusitis  1  0/5 (0.00%)  1/4 (25.00%)  2/31 (6.45%) 
Urinary tract infection  1  0/5 (0.00%)  1/4 (25.00%)  1/31 (3.23%) 
Injury, poisoning and procedural complications       
Contusion  1  1/5 (20.00%)  0/4 (0.00%)  4/31 (12.90%) 
Thermal burn  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Fall  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Investigations       
Haemoglobin decreased  1  1/5 (20.00%)  3/4 (75.00%)  3/31 (9.68%) 
Aspartate aminotransferase increased  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Blood calcium decreased  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Blood creatinine increased  1  0/5 (0.00%)  1/4 (25.00%)  4/31 (12.90%) 
Blood glucose increased  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Blood magnesium decreased  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Blood potassium decreased  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Cardiac murmur  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Hematocrit decreased  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Neutrophil count decreased  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Weight decreased  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Metabolism and nutrition disorders       
Hypercalcaemia  1  1/5 (20.00%)  1/4 (25.00%)  2/31 (6.45%) 
Decreased appetite  1  0/5 (0.00%)  0/4 (0.00%)  11/31 (35.48%) 
Hyperglycaemia  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Hypocalcaemia  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Hypoglycaemia  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Hypokalaemia  1  0/5 (0.00%)  0/4 (0.00%)  4/31 (12.90%) 
Hyponatraemia  1  0/5 (0.00%)  1/4 (25.00%)  2/31 (6.45%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  3/5 (60.00%)  1/4 (25.00%)  6/31 (19.35%) 
Musculoskeletal chest pain  1  3/5 (60.00%)  0/4 (0.00%)  1/31 (3.23%) 
Joint swelling  1  1/5 (20.00%)  0/4 (0.00%)  1/31 (3.23%) 
Limb discomfort  1  1/5 (20.00%)  0/4 (0.00%)  1/31 (3.23%) 
Muscle spasms  1  1/5 (20.00%)  1/4 (25.00%)  2/31 (6.45%) 
Muscular weakness  1  1/5 (20.00%)  0/4 (0.00%)  1/31 (3.23%) 
Pain in extremity  1  1/5 (20.00%)  1/4 (25.00%)  5/31 (16.13%) 
Rotator cuff syndrome  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Arthralgia  1  0/5 (0.00%)  0/4 (0.00%)  6/31 (19.35%) 
Bone pain  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Muscularskeletal discomfort  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Muscularskeletal pain  1  0/5 (0.00%)  1/4 (25.00%)  4/31 (12.90%) 
Myalgia  1  0/5 (0.00%)  0/4 (0.00%)  4/31 (12.90%) 
Osteonecrosis of jaw  1  0/5 (0.00%)  1/4 (25.00%)  1/31 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squamous cell carcinoma of skin  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Tumour pain  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Nervous system disorders       
Headache  1  1/5 (20.00%)  2/4 (50.00%)  5/31 (16.13%) 
Neuropathy peripheral  1  1/5 (20.00%)  2/4 (50.00%)  10/31 (32.26%) 
Balance disorder  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Dizziness  1  0/5 (0.00%)  1/4 (25.00%)  4/31 (12.90%) 
Paraesthesia  1  0/5 (0.00%)  0/4 (0.00%)  3/31 (9.68%) 
Tremor  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Psychiatric disorders       
Insomnia  1  0/5 (0.00%)  0/4 (0.00%)  4/31 (12.90%) 
Reproductive system and breast disorders       
Breast tenderness  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  2/5 (40.00%)  0/4 (0.00%)  0/31 (0.00%) 
Dyspnoea  1  1/5 (20.00%)  0/4 (0.00%)  6/31 (19.35%) 
Oropharyngeal pain  1  1/5 (20.00%)  0/4 (0.00%)  3/31 (9.68%) 
Rhinitis allergic  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Cough  1  0/5 (0.00%)  0/4 (0.00%)  5/31 (16.13%) 
Dyspnoea exertional  1  0/5 (0.00%)  1/4 (25.00%)  1/31 (3.23%) 
Skin and subcutaneous tissue disorders       
Rash  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Skin disorder  1  1/5 (20.00%)  0/4 (0.00%)  0/31 (0.00%) 
Ecchymosis  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Hyperhidrosis  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Nail growth abnormal  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Precancerous skin lesion  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Skin atrophy  1  0/5 (0.00%)  1/4 (25.00%)  1/31 (3.23%) 
Vascular disorders       
Hot flush  1  0/5 (0.00%)  1/4 (25.00%)  0/31 (0.00%) 
Hypotension  1  0/5 (0.00%)  1/4 (25.00%)  2/31 (6.45%) 
Vein pain  1  0/5 (0.00%)  0/4 (0.00%)  2/31 (6.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor’s review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor’s designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
EMail: ustevatrials@tevapharm.com
Publications of Results:
Berenson JR, Yellin O, Bessudo A, et al. Bendamustine combined with bortezomib has efficacy in patients with relapsed or refractory multiple myeloma: a phase 1/2 study. Blood (ASH Annual Meeting Abstracts). 2011;118 (suppl 21):abstract 1857
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00920855     History of Changes
Other Study ID Numbers: C18083/1063/MM/US
First Submitted: June 11, 2009
First Posted: June 15, 2009
Results First Submitted: August 15, 2012
Results First Posted: September 17, 2012
Last Update Posted: October 4, 2012