Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Alternative Schedule of Velcade/Dexamethasone Plus Doxil for Patients With 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: NCT00366106
Recruitment Status : Terminated (Study was closed to enrollment when it became clear that enrollment was too slow to complete full enrollment target within time frame allowed.)
First Posted : August 18, 2006
Results First Posted : April 5, 2012
Last Update Posted : April 6, 2012
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: bortezomib
Drug: dexamethasone
Drug: doxorubicin HCl liposome
Enrollment 32
Recruitment Details 15 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in July 2006 but was stopped in December 2008 at the point when it became clear that enrollment was too slow to complete the planned enrollment target of 45 patients within the time frame allowed.
Pre-assignment Details Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
Arm/Group Title Treatment Group
Hide Arm/Group Description All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
Period Title: Overall Study
Started 32
Completed 32
Not Completed 0
Arm/Group Title Treatment Group
Hide Arm/Group Description All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  43.8%
>=65 years
18
  56.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
63.7  (10.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
15
  46.9%
Male
17
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Incidence of Treatment-emergent Peripheral Neuropathy
Hide Description [Not Specified]
Time Frame Every 4 weeks from start of treatment until end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
Hide Arm/Group Description:
All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Participants
11
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description [Not Specified]
Time Frame TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
Hide Arm/Group Description:
All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: Months
23.07  (3.20)
3.Secondary Outcome
Title Number of Participants With Treatment Response
Hide Description Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and <5% plasma cells in bone marrow. PR also required >=50% SPEP reduction, >=90% UPEP reduction, and >=50% reduction in plasma cells in bone marrow. MR also required >=25% SPEP reduction, >=50% UPEP reduction, and > 25% reduction in plasma cells.
Time Frame Every 8 weeks from start of treatment until end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
Hide Arm/Group Description:
All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: Participants
NA [1] 
[1]
We were unable to assess participant response to treatment due to missingness of data required for determination of response.
4.Secondary Outcome
Title Relative Dose Intensity of Bortezomib
Hide Description Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.
Time Frame Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.
Arm/Group Title Treatment Group
Hide Arm/Group Description:
All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: Relative dose intensity
Cycle 1 / Week 1 0.97  (0.158)
Cycle 1 / Week 1 Day 4 0.98  (0.159)
Cycle 1 / Week 3 0.97  (0.158)
Cycle 1 / Week 3 Day 18 0.97  (0.154)
Cycle 2 / Week 5 0.95  (0.144)
Cycle 2 / Week 5 Day 4 0.96  (0.148)
Cycle 2 / Week 7 0.95  (0.140)
Cycle 2 / Week 7 Day 18 0.96  (0.146)
Cycle 3 / Week 9 0.99  (0.147)
Cycle 3 / Week 9 Day 4 0.97  (0.121)
Cycle 3 / Week 11 0.97  (0.142)
Cycle 3 / Week 11 Day 18 0.95  (0.104)
Cycle 4 / Week 13 0.99  (0.152)
Cycle 4 / Week 13 Day 4 0.96  (0.111)
Cycle 4 / Week 15 0.99  (0.154)
Cycle 4 / Week 15 Day 18 0.96  (0.111)
Cycle 5 / Week 17 0.98  (0.151)
Cycle 5 / Week 17 Day 4 0.96  (0.110)
Cycle 5 / Week 19 1.00  (0.157)
Cycle 5 / Week 19 Day 18 0.97  (0.111)
Cycle 6 / Week 21 1.01  (0.162)
Cycle 6 / Week 21 Day 4 0.98  (0.114)
Cycle 6 / Week 23 1.01  (0.169)
Cycle 6 / Week 23 Day 18 0.99  (0.115)
Cycle 7 / Week 25 1.11  (0.154)
Cycle 7 / Week 25 Day 4 1.03  (0.148)
Cycle 7 / Week 27 1.08  (0.198)
Cycle 7 / Week 27 Day 18 1.03  (0.148)
Cycle 8 / Week 29 1.05  (0.213)
Cycle 8 / Week 29 Day 4 0.99  (0.140)
Cycle 8 / Week 31 1.05  (0.213)
Cycle 8 / Week 31 Day 18 1.04  (0.085)
Cycle 9 / Week 33 1.10  (0.488)
Cycle 9 / Week 33 Day 4 0.75 [1]   (NA)
Cycle 9 / Week 35 1.15  (0.417)
Cycle 10 / Week 37 1.22  (0.311)
Cycle 10 / Week 37 Day 4 1.00 [1]   (NA)
Cycle 10 / Week 39 1.22  (0.311)
Cycle 10 / Week 39 Day 18 1.00 [1]   (NA)
Cycle 11 / Week 41 1.22  (0.311)
Cycle 11 / Week 41 Day 4 1.00 [1]   (NA)
Cycle 11 / Week 43 1.44 [1]   (NA)
Cycle 11 / Week 43 Day 18 1.00 [1]   (NA)
[1]
Only 1 patient was dosed.
Time Frame Adverse events were collected beginning on day 1 of study treatment until one month after the end of study treatment.
Adverse Event Reporting Description Systematic Assessment - subjects were assessed for adverse events weekly by either the research coordinator, treating physician, or other appropriate sub-investigator.
 
Arm/Group Title Treatment Group
Hide Arm/Group Description All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
All-Cause Mortality
Treatment Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Group
Affected / at Risk (%)
Total   10/32 (31.25%) 
Blood and lymphatic system disorders   
Anemia * 1  1/32 (3.13%) 
Cardiac disorders   
Atrial fibrillation * 1  1/32 (3.13%) 
Gastrointestinal disorders   
Diarrhea * 1  1/32 (3.13%) 
Dysphagia * 1  1/32 (3.13%) 
General disorders   
Fatigue * 1  2/32 (6.25%) 
Infections and infestations   
Cellulitis * 1  1/32 (3.13%) 
Herpes zoster * 1  1/32 (3.13%) 
Pneumonia * 1  2/32 (6.25%) 
Sepsis * 1  1/32 (3.13%) 
Investigations   
Aspartate aminotransferase increased * 1  1/32 (3.13%) 
Blood creatinine increased * 1  1/32 (3.13%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/32 (3.13%) 
Hypercalcemia * 1  1/32 (3.13%) 
Hyperglycemia * 1  1/32 (3.13%) 
Hyperglycemic hyperosmolar nonketotic syndrome * 1  1/32 (3.13%) 
Hypoglycemia * 1  1/32 (3.13%) 
Psychiatric disorders   
Mental status changes * 1  1/32 (3.13%) 
Renal and urinary disorders   
Renal failure * 1  2/32 (6.25%) 
Renal failure acute * 1  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/32 (3.13%) 
Hypoxia * 1  1/32 (3.13%) 
Vascular disorders   
Hypotension * 1  1/32 (3.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Group
Affected / at Risk (%)
Total   28/32 (87.50%) 
Blood and lymphatic system disorders   
Anemia  1  5/32 (15.63%) 
Febrile neutropenia  1  1/32 (3.13%) 
Hemorrhagic diathesis  1  1/32 (3.13%) 
Leukocytosis  1  1/32 (3.13%) 
Neutropenia  1  3/32 (9.38%) 
Thrombocytopenia  1  1/32 (3.13%) 
Ear and labyrinth disorders   
Ear pain  1  1/32 (3.13%) 
Tinnitus  1  1/32 (3.13%) 
Eye disorders   
Eye discharge  1  1/32 (3.13%) 
Eye irritation  1  1/32 (3.13%) 
Lacrimation increased  1  1/32 (3.13%) 
Ocular surface disease  1  1/32 (3.13%) 
Vision blurred  1  1/32 (3.13%) 
Visual impairment  1  1/32 (3.13%) 
Gastrointestinal disorders   
Abdominal pain lower  1  1/32 (3.13%) 
Constipation  1  11/32 (34.38%) 
Diarrhea  1  7/32 (21.88%) 
Dry mouth  1  2/32 (6.25%) 
Dyspepsia  1  1/32 (3.13%) 
Flatulence  1  1/32 (3.13%) 
Gastroesophageal reflux disease  1  1/32 (3.13%) 
Glossodynia  1  1/32 (3.13%) 
Nausea  1  8/32 (25.00%) 
Oral pain  1  1/32 (3.13%) 
Parotid gland enlargement  1  1/32 (3.13%) 
Rectal hemorrhage  1  1/32 (3.13%) 
Stomatitis  1  2/32 (6.25%) 
Vomiting  1  7/32 (21.88%) 
General disorders   
Asthenia  1  2/32 (6.25%) 
Chest pain  1  2/32 (6.25%) 
Chills  1  1/32 (3.13%) 
Face edema  1  1/32 (3.13%) 
Facial pain  1  1/32 (3.13%) 
Fatigue  1  9/32 (28.13%) 
Lethargy  1  1/32 (3.13%) 
Mucosal inflammation  1  1/32 (3.13%) 
Edema peripheral  1  7/32 (21.88%) 
Pain  1  1/32 (3.13%) 
Pyrexia  1  3/32 (9.38%) 
Infections and infestations   
Abscess jaw  1  1/32 (3.13%) 
Adenoviral upper respiratory infection  1  1/32 (3.13%) 
Eye infection  1  1/32 (3.13%) 
Herpes zoster  1  4/32 (12.50%) 
Oral fungal infection  1  1/32 (3.13%) 
Sinusitis  1  1/32 (3.13%) 
Skin infection  1  1/32 (3.13%) 
Upper respiratory tract infection  1  3/32 (9.38%) 
Urinary tract infections  1  2/32 (6.25%) 
Vulvovaginal mycotic infection  1  1/32 (3.13%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  1/32 (3.13%) 
Barotitis media  1  1/32 (3.13%) 
Contusion  1  2/32 (6.25%) 
Fall  1  1/32 (3.13%) 
Vaginal laceration  1  1/32 (3.13%) 
Investigations   
Alanine aminotransferase increased  1  1/32 (3.13%) 
Aspartate aminotransferase increased  1  1/32 (3.13%) 
Blood alkaline phosphatase increased  1  1/32 (3.13%) 
Blood creatine increased  1  1/32 (3.13%) 
Blood creatinine increased  1  1/32 (3.13%) 
Blood glucose increased  1  2/32 (6.25%) 
Blood lactate dehydrogenase increased  1  1/32 (3.13%) 
Blood potassium decreased  1  1/32 (3.13%) 
Blood potassium increased  1  3/32 (9.38%) 
Blood urea decreased  1  2/32 (6.25%) 
Gamma-glutamyltransferase increased  1  1/32 (3.13%) 
Hemoglobin decreased  1  2/32 (6.25%) 
Heart rate increased  1  1/32 (3.13%) 
Platelet count decreased  1  2/32 (6.25%) 
Weight decreased  1  1/32 (3.13%) 
Weight increased  1  2/32 (6.25%) 
Metabolism and nutrition disorders   
Decreased appetite  1  3/32 (9.38%) 
Dehydration  1  1/32 (3.13%) 
Fluid retention  1  1/32 (3.13%) 
Hyperglycemia  1  3/32 (9.38%) 
Hyperkalemia  1  1/32 (3.13%) 
Hypoalbuminemia  1  1/32 (3.13%) 
Hypocalcemia  1  2/32 (6.25%) 
Hypokalemia  1  2/32 (6.25%) 
Hyponatremia  1  2/32 (6.25%) 
Increased appetite  1  3/32 (9.38%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/32 (6.25%) 
Back pain  1  3/32 (9.38%) 
Flank pain  1  1/32 (3.13%) 
Joint stiffness  1  1/32 (3.13%) 
Joint swelling  1  1/32 (3.13%) 
Muscle spasms  1  1/32 (3.13%) 
Muscular weakness  1  3/32 (9.38%) 
Musculoskeletal chest pain  1  2/32 (6.25%) 
Musculoskeletal pain  1  3/32 (9.38%) 
Myalgia  1  2/32 (6.25%) 
Osteoarthritis  1  1/32 (3.13%) 
Pain in extremity  1  3/32 (9.38%) 
Nervous system disorders   
Amnesia  1  1/32 (3.13%) 
Burning feet syndrome  1  1/32 (3.13%) 
Burning sensation  1  1/32 (3.13%) 
Dizziness  1  2/32 (6.25%) 
Dysgeusia  1  4/32 (12.50%) 
Headache  1  3/32 (9.38%) 
Hypoesthesia  1  2/32 (6.25%) 
Migraine  1  1/32 (3.13%) 
Neuralgia  1  1/32 (3.13%) 
Neuropathy peripheral  1  11/32 (34.38%) 
Paresthesia  1  5/32 (15.63%) 
Parosmia  1  1/32 (3.13%) 
Peripheral sensory neuropathy  1  2/32 (6.25%) 
Syncope  1  2/32 (6.25%) 
Psychiatric disorders   
Anxiety  1  2/32 (6.25%) 
Depression  1  2/32 (6.25%) 
Insomnia  1  4/32 (12.50%) 
Nervousness  1  1/32 (3.13%) 
Renal and urinary disorders   
Renal tubular acidosis  1  1/32 (3.13%) 
Reproductive system and breast disorders   
Erectile dysfunction  1  1/32 (3.13%) 
Vaginal hemorrhage  1  1/32 (3.13%) 
Vaginal mucosal blistering  1  1/32 (3.13%) 
Vulvovaginal pruritis  1  2/32 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  7/32 (21.88%) 
Dyspnea  1  4/32 (12.50%) 
Epistaxis  1  1/32 (3.13%) 
Hemoptysis  1  1/32 (3.13%) 
Oropharyngeal blistering  1  1/32 (3.13%) 
Oropharyngeal pain  1  2/32 (6.25%) 
Postnasal drip  1  1/32 (3.13%) 
Productive cough  1  1/32 (3.13%) 
Rhinorrhea  1  2/32 (6.25%) 
Sinus congestion  1  1/32 (3.13%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/32 (3.13%) 
Blister  1  1/32 (3.13%) 
Hyperhidrosis  1  1/32 (3.13%) 
Palmar-plantar erythrodysesthesia syndrome  1  1/32 (3.13%) 
Pruritis  1  1/32 (3.13%) 
Rash  1  4/32 (12.50%) 
Rash erythematous  1  1/32 (3.13%) 
Skin discoloration  1  1/32 (3.13%) 
Urticaria  1  2/32 (6.25%) 
Vascular disorders   
Ecchymosis  1  1/32 (3.13%) 
Hypertension  1  1/32 (3.13%) 
Hypotension  1  1/32 (3.13%) 
Orthostatic hypotension  1  1/32 (3.13%) 
Phlebitis  1  1/32 (3.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
The study was closed to enrollment when it became clear that enrollment was too slow to complete the planned enrollment target of 45 patients within the time frame allowed. Response rate was unable to be assessed due to missingness of required data.
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.
A copy of the disclosure must be given to Millennium for review at least 30 days before it is submitted for publication or disclosure. If a Development is contained in the disclosure, Research Organization and/or Principal Investigator defer publication or disclosure for 90 days from the time Millennium notifies that it wants to file a patent application on the Development provided such notice was provided by Millennium within 30 days of the copy first provided to Millennium.
Results Point of Contact
Name/Title: Vice President of Scientific Affairs
Organization: Accelerated Community Oncology Research Network, Inc.
Phone: 901-435-5570
Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00366106     History of Changes
Other Study ID Numbers: ACORN ALJBMM0502
First Submitted: August 16, 2006
First Posted: August 18, 2006
Results First Submitted: September 26, 2011
Results First Posted: April 5, 2012
Last Update Posted: April 6, 2012