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Trial record 96 of 108 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00441168
Recruitment Status : Terminated (TRIAL STOPPED due to a change in standard of care and the required patient numbers could no longer be achieved)
First Posted : February 28, 2007
Results First Posted : March 21, 2014
Last Update Posted : March 21, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: adriamycin
Drug: bortezomib
Drug: dexamethasone
Drug: vincristine
Enrollment 30
Recruitment Details Subjects were recruited from 05 December 2006 to 04 July 2007 at 2 sites in Germany, 1 site in Hungary, 3 sites in Lithuania, 3 sites in Poland and 3 sites in Russia
Pre-assignment Details Subjects who qualified were screened. Subjects were considered for eligibility when the investigator would treat the subject with a combination therapy of vincristine, adriamycin and dexamethasone (VAD) standard therapy. One subject was not randomised because the subject was a screening failure.
Arm/Group Title VAD Treatment PAD Treatment
Hide Arm/Group Description vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
Period Title: Treatment Period
Started 17 13
TREATED 16 13
Completed 6 7
Not Completed 11 6
Reason Not Completed
Death             3             0
Adverse Event             1             2
Progressive Disease             0             2
Protocol Violation             0             1
Lost to Follow-up             0             1
Withdrawal by Subject             3             0
qualified for stem-cell transplantation             3             0
refractory disease             1             0
Period Title: Follow-up Period
Started 17 [1] 13 [1]
Completed 5 4
Not Completed 12 9
Reason Not Completed
Death             3             0
Lost to Follow-up             5             6
Withdrawal by Subject             3             0
Other             1             3
[1]
Subjects who did not complete the treatment period could be entered into the follow-up period
Arm/Group Title VAD Treatment PAD Treatment Total
Hide Arm/Group Description vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle Total of all reporting groups
Overall Number of Baseline Participants 16 13 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 13 participants 29 participants
64.0  (9.4) 61.5  (11.3) 62.9  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Female
5
  31.3%
3
  23.1%
8
  27.6%
Male
11
  68.8%
10
  76.9%
21
  72.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
16
 100.0%
13
 100.0%
29
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Karnofsky Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
≤50 0 0 0
60 1 1 2
70 1 3 4
80 9 3 12
90 5 3 8
100 0 3 3
[1]
Measure Description: A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Scores (KPS) range from 0 to 100. A higher score means the patient is better able to carry out daily activities. KPS may be used to determine a patient's prognosis, to measure changes in a patient’s ability to function, or to decide if a patient could be included in a clinical trial.
Body Surface Area  
Mean (Standard Deviation)
Unit of measure:  M2
Number Analyzed 16 participants 13 participants 29 participants
1.855  (0.233) 1.924  (0.219) 1.886  (0.226)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 16 participants 13 participants 29 participants
168.8  (11.2) 169.8  (9.5) 169.3  (10.3)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 16 participants 13 participants 29 participants
75.9  (15.7) 78.3  (14.5) 77.0  (15.0)
1.Primary Outcome
Title Best Confirmed Disease Response
Hide Description The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease [PD], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.
Time Frame every 28 days during treatment period for up to 6 to 8 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.
Arm/Group Title VAD Treatment PAD Treatment
Hide Arm/Group Description:
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
Overall Number of Participants Analyzed 15 13
Measure Type: Number
Unit of Measure: participants
CR 0 1
PR 5 6
Response Rate (CR + PR) 5 7
MR 2 0
Overall Response (CR + PR + MR) 7 7
NC 3 1
PD 1 1
Unknown/Unable to Assess 4 4
2.Primary Outcome
Title Best Reported Disease Response
Hide Description The primary efficacy analysis was based on the best response obtained during the treatment period according to the EBMT criteria as assessed by the investigator. The ordering of the responses was: CR, PR, MR, NC and PD. CR was the best response and the poorest response was PD.
Time Frame every 28 days during treatment period for up to 6 to 8 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.
Arm/Group Title VAD Treatment PAD Treatment
Hide Arm/Group Description:
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
Overall Number of Participants Analyzed 15 13
Measure Type: Number
Unit of Measure: participants
CR 1 3
PR 6 4
Response Rate (CR + PR) 7 7
MR 2 3
Overall Response (CR + PR + MR) 9 10
NC 5 3
PD 0 0
Unknown/Unable to Assess 1 0
3.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined as the duration from the date of the best confirmed response for subjects who achieved CR or PR to the date of first documented evidence of PD (or relapse for subjects who experienced CR) over the duration of the study. DOR = ([Date of PD or date of censoring – Date of best response]+1)/30.44.
Time Frame every 28 days during treatment period for up to 6 to 8 cycles
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.There was insufficient data to perform Kaplan Meier analysis (data available for 5 subjects in the VAD group and 6 subjects in the PAD group).
Arm/Group Title VAD Treatment PAD Treatment
Hide Arm/Group Description:
vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
Overall Number of Participants Analyzed 5 6
Measure Type: Number
Unit of Measure: months
patient 1 1.68 2.83
patient 2 6.18 7.69
patient 3 3.71 5.52
patient 4 5.42 6.57
patient 5 4.73 4.96
patient 6 NA [1]  7.42
[1]
only 5 patients have been analyzed in this arm
Time Frame For up to 6 to 8 cycles, consisting of 28 days each, and for up to a 1-year follow-up period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VAD Treatment PAD Treatment
Hide Arm/Group Description vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
All-Cause Mortality
VAD Treatment PAD Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
VAD Treatment PAD Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/16 (37.50%)      5/13 (38.46%)    
Blood and lymphatic system disorders     
Neutropenia  1  1/16 (6.25%)  1 1/13 (7.69%)  1
Thrombocytopenia  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Cardiac disorders     
Angina unstable  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Cardiac failure chronic  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Supraventricular tachycardia  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Gastrointestinal disorders     
Diarrhoea  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Vomiting  1  0/16 (0.00%)  0 1/13 (7.69%)  2
General disorders     
Asthenia  1  0/16 (0.00%)  0 1/13 (7.69%)  2
Death  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Sudden cardiac death  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Infections and infestations     
Bronchitis acute  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Bursitis infective  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Pneumonia  1  2/16 (12.50%)  2 1/13 (7.69%)  2
Pyelonephritis acute  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Septic shock  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Injury, poisoning and procedural complications     
Spinal fracture  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Cough  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Respiratory failure  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VAD Treatment PAD Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/16 (93.75%)      8/13 (61.54%)    
Blood and lymphatic system disorders     
Anaemia  1  1/16 (6.25%)  1 1/13 (7.69%)  2
Leukocytosis  1  0/16 (0.00%)  0 1/13 (7.69%)  2
Leukopenia  1  2/16 (12.50%)  3 0/13 (0.00%)  0
Lymphopenia  1  4/16 (25.00%)  11 2/13 (15.38%)  7
Neutropenia  1  4/16 (25.00%)  9 1/13 (7.69%)  3
Thrombocytopenia  1  1/16 (6.25%)  1 1/13 (7.69%)  4
Ear and labyrinth disorders     
Vertigo  1  2/16 (12.50%)  2 0/13 (0.00%)  0
Eye disorders     
Eye irritation  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Visual acuity reduced  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  1/16 (6.25%)  4 0/13 (0.00%)  0
Diarrhoea  1  2/16 (12.50%)  2 1/13 (7.69%)  1
General disorders     
Asthenia  1  1/16 (6.25%)  1 1/13 (7.69%)  1
Extravasation  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Face oedema  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Fatigue  1  3/16 (18.75%)  4 2/13 (15.38%)  2
Oedema peripheral  1  1/16 (6.25%)  2 1/13 (7.69%)  1
Pyrexia  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations     
Abscess limb  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Bronchitis acute  1  2/16 (12.50%)  2 1/13 (7.69%)  1
Cystitis  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Herpes simplex  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Herpes zoster  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Infection  1  1/16 (6.25%)  2 0/13 (0.00%)  0
Nasopharyngitis  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Pneumonia  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Respiratory tract infection  1  2/16 (12.50%)  2 0/13 (0.00%)  0
Viral infection  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Investigations     
White blood cell count increased  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Hyperglycaemia  1  1/16 (6.25%)  1 1/13 (7.69%)  1
Hypocalcaemia  1  0/16 (0.00%)  0 1/13 (7.69%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  2/16 (12.50%)  3 1/13 (7.69%)  1
Bone pain  1  1/16 (6.25%)  1 1/13 (7.69%)  1
Bursitis  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Pain in extremity  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Shoulder pain  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Nervous system disorders     
Ageusia  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Neuropathy peripheral  1  0/16 (0.00%)  0 1/13 (7.69%)  1
Peripheral sensory neuropathy  1  1/16 (6.25%)  3 2/13 (15.38%)  4
Psychiatric disorders     
Anxiety  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Insomnia  1  2/16 (12.50%)  2 4/13 (30.77%)  5
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/16 (6.25%)  1 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Night sweats  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Vascular disorders     
Hypertension  1  1/16 (6.25%)  1 2/13 (15.38%)  2
Thrombophlebitis  1  1/16 (6.25%)  2 0/13 (0.00%)  0
Venous thrombosis limb  1  1/16 (6.25%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Due to a substantial decline in the use of the VAD regimen as standard of care, recruitment of the study was halted at 30 subjects. It was not possible to statistically evaluate any long term efficacy parameter.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: EMEA Medical Affairs Director Oncology
Organization: Jan-Cilag Germany
Phone: +49 2137 955-492
EMail: rangermu@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT00441168     History of Changes
Other Study ID Numbers: CR011065
26866138MMY2038 ( Other Identifier: Janssen-Cilag International NV )
2006-001709-27 ( EudraCT Number )
First Submitted: February 27, 2007
First Posted: February 28, 2007
Results First Submitted: December 3, 2009
Results First Posted: March 21, 2014
Last Update Posted: March 21, 2014