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Study of VELCADE® With Mitoxantrone and Etoposide for Leukemias

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ClinicalTrials.gov Identifier: NCT00410423
Recruitment Status : Completed
First Posted : December 12, 2006
Results First Posted : April 17, 2018
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Relapsed Acute Leukemia
Refractory Acute Leukemia
Interventions Drug: Bortezomib with mitoxantrone, etoposide and cytarabine
Drug: Bortezomib 1.0mg/m^2
Drug: Bortezomib 1.3mg/m^2
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1 - Bortezomib 0.7mg/m^2 Phase 1 - Bortezomib 1.0 mg/m^2 Phase 1 - Bortezomib 1.3 mg/m^2 Phase 2 - Bortezomib 1.3mg/m^2
Hide Arm/Group Description

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Period Title: Phase 1 - Dose Level 1
Started 3 0 0 0
Completed 3 0 0 0
Not Completed 0 0 0 0
Period Title: Phase 1 - Dose Level 2
Started 0 5 0 0
Completed 0 5 0 0
Not Completed 0 0 0 0
Period Title: Phase 1 - Dose Level 3
Started 0 0 3 0
Completed 0 0 3 0
Not Completed 0 0 0 0
Period Title: Phase 2
Started 0 0 0 44
Completed 0 0 0 44
Not Completed 0 0 0 0
Arm/Group Title Bortezomib
Hide Arm/Group Description

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
<=18 years
0
   0.0%
Between 18 and 65 years
44
  80.0%
>=65 years
11
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
51.39  (15.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
29
  52.7%
Male
26
  47.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Hispanic or Latino
3
   5.5%
Not Hispanic or Latino
30
  54.5%
Unknown or Not Reported
22
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   5.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  16.4%
White
35
  63.6%
More than one race
0
   0.0%
Unknown or Not Reported
8
  14.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants
55
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicity in Phase I
Hide Description Dose limiting toxicity (DLT) is defined as grade-3 toxicity definitely related to bortezomib or grade-4 toxicity probably or definitely related to bortezomib.
Time Frame 30-90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 1 - Bortezomib 0.7mg/m^2 Phase 1 - Bortezomib 1.0 mg/m^2 Phase 1 - Bortezomib 1.3mg/m^2
Hide Arm/Group Description:

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

Overall Number of Participants Analyzed 3 5 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Complete Response Rate to 1.3mg/m^2 of Bortezomib With Mitoxantrone and Etoposide in Phase II
Hide Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.

The percentage of participants that experienced complete response will be reported.

Time Frame Up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase 2 - Bortezomib 1.3mg/m^2
Hide Arm/Group Description:
Bortezomib 1.3mg/m2: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
27
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events not available for 17 patients--these patients are excluded from adverse event counts
 
Arm/Group Title Bortezomib
Hide Arm/Group Description

Bortezomib in combination with mitoxantrone, etoposide and cytarabine

Bortezomib with mitoxantrone, etoposide and cytarabine: All patients receive bortezomib in combination with mitoxantrone, etoposide and cytarabine. This is a 5 day chemotherapy regimen that is administered in the hospital.

All-Cause Mortality
Bortezomib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib
Affected / at Risk (%) # Events
Total   10/38 (26.32%)    
Blood and lymphatic system disorders   
Febrile neutropenia  9/38 (23.68%)  9
General disorders   
Cough  1/38 (2.63%)  1
Infections and infestations   
Infection  2/38 (5.26%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1/38 (2.63%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bortezomib
Affected / at Risk (%) # Events
Total   38/38 (100.00%)    
Blood and lymphatic system disorders   
Bleeding  3/38 (7.89%)  4
Febrile neutropenia  12/38 (31.58%)  14
Hematuria  2/38 (5.26%)  2
Hyperbilirubinemia  2/38 (5.26%)  2
Hyperkalemia  1/38 (2.63%)  1
Hyperphosphatemia  1/38 (2.63%)  1
Hypertension  6/38 (15.79%)  6
Hyperuricemia  1/38 (2.63%)  1
Hypoglycemia  2/38 (5.26%)  2
Hypokalemia  5/38 (13.16%)  5
Hyponatremia  1/38 (2.63%)  1
Hypophosphatemia  1/38 (2.63%)  1
Hypotension  16/38 (42.11%)  18
Increased alklaline phosphatase  2/38 (5.26%)  2
Increased ALT  3/38 (7.89%)  6
Increased AST  3/38 (7.89%)  3
Increased creatinine  1/38 (2.63%)  1
Neutropenia  4/38 (10.53%)  4
Thrombocytopenia  2/38 (5.26%)  2
Cardiac disorders   
Atrial fibrillation  2/38 (5.26%)  2
Congestive heart failure  1/38 (2.63%)  1
Palpitations  1/38 (2.63%)  1
Pericardial effusion  1/38 (2.63%)  1
Sinus bradycardia  1/38 (2.63%)  1
Sinus tachycardia  7/38 (18.42%)  7
Tachycardia  8/38 (21.05%)  8
Endocrine disorders   
Hypothyroidism  1/38 (2.63%)  1
Eye disorders   
Change in vision  3/38 (7.89%)  3
Dry eyes  1/38 (2.63%)  1
Itchy eyes  1/38 (2.63%)  1
Gastrointestinal disorders   
Bloating  2/38 (5.26%)  2
Constipation  14/38 (36.84%)  17
Diarrhea  19/38 (50.00%)  19
Distended abdomen  3/38 (7.89%)  3
Dyspepsia  2/38 (5.26%)  2
Epigastric discomfort  1/38 (2.63%)  1
Flatulence  1/38 (2.63%)  1
Gas pain  1/38 (2.63%)  1
Gastroesophageal reflux disease  2/38 (5.26%)  2
Heartburn  1/38 (2.63%)  1
Hemorrhoids  4/38 (10.53%)  4
Mucositis  16/38 (42.11%)  17
General disorders   
Abdominal pain  10/38 (26.32%)  11
Achiness  2/38 (5.26%)  2
Acute infusion reaction  7/38 (18.42%)  13
Allergic reaction  3/38 (7.89%)  7
Alopecia  6/38 (15.79%)  6
Anorexia  16/38 (42.11%)  19
Arm pain  3/38 (7.89%)  4
Back pain  7/38 (18.42%)  8
Blood-tinged mucus  1/38 (2.63%)  1
Bone pain  3/38 (7.89%)  4
Breast mass  1/38 (2.63%)  1
Bump on finger  1/38 (2.63%)  1
Calf pain  1/38 (2.63%)  1
Chest pain  6/38 (15.79%)  7
Chills  10/38 (26.32%)  11
Chronic rhinsinusitis  1/38 (2.63%)  1
Cough  9/38 (23.68%)  10
Decreased appetite  3/38 (7.89%)  3
Dehydration  1/38 (2.63%)  1
Dizziness  9/38 (23.68%)  9
Dry cough  1/38 (2.63%)  1
Dry mouth  1/38 (2.63%)  1
Dry, cracked lips  2/38 (5.26%)  2
Dysgeusia  2/38 (5.26%)  2
Dysphagia  3/38 (7.89%)  3
Elbow pain  1/38 (2.63%)  1
Epistaxis  2/38 (5.26%)  2
Facial swelling  1/38 (2.63%)  1
Fatigue  18/38 (47.37%)  19
Fever  9/38 (23.68%)  12
Fistula  1/38 (2.63%)  1
Flank pain  1/38 (2.63%)  1
Fluid retention  1/38 (2.63%)  1
Foot pain  1/38 (2.63%)  1
Gum swelling  1/38 (2.63%)  1
Hand pain  2/38 (5.26%)  2
Headache  17/38 (44.74%)  19
Hoarseness  1/38 (2.63%)  1
Hot flashes  1/38 (2.63%)  1
Incontinence of stool  1/38 (2.63%)  1
Insomnia  5/38 (13.16%)  5
Iron overload  1/38 (2.63%)  1
Joint pain  2/38 (5.26%)  2
Knee pain  1/38 (2.63%)  1
Leg pain  4/38 (10.53%)  5
Muscle cramping  1/38 (2.63%)  1
Muscle pain  3/38 (7.89%)  3
Nausea  27/38 (71.05%)  32
Neck pain  3/38 (7.89%)  3
Night sweats  1/38 (2.63%)  1
Oral pain  4/38 (10.53%)  4
Oral thrush  3/38 (7.89%)  3
Pain at femoral line site  1/38 (2.63%)  1
Pain at PICC site  5/38 (13.16%)  5
Pain from bone marrow biopsy  6/38 (15.79%)  6
Pain from mouth sore  1/38 (2.63%)  1
Rhinitis  2/38 (5.26%)  3
Rib pain  1/38 (2.63%)  1
Shoulder pain  2/38 (5.26%)  2
Sinus congestion  1/38 (2.63%)  1
Sinus headache  2/38 (5.26%)  2
Sinus pain  1/38 (2.63%)  1
Sinusitis  3/38 (7.89%)  3
Sore in mouth  2/38 (5.26%)  3
Sore throat  3/38 (7.89%)  3
Sternal pain  1/38 (2.63%)  1
Stomach pain  1/38 (2.63%)  1
Sweating  4/38 (10.53%)  4
Swelling of parotid gland  1/38 (2.63%)  1
Thigh pain  2/38 (5.26%)  2
Toe pain  1/38 (2.63%)  1
Tongue pain  1/38 (2.63%)  1
Tooth pain  1/38 (2.63%)  1
Tremors  2/38 (5.26%)  2
Trouble sleeping  2/38 (5.26%)  2
Weakness  13/38 (34.21%)  13
Weight gain  1/38 (2.63%)  2
Weight loss  1/38 (2.63%)  1
Wheezing  1/38 (2.63%)  1
Lethargy  1/38 (2.63%)  1
Hepatobiliary disorders   
Liver dysfunction  1/38 (2.63%)  1
Infections and infestations   
Clostridium difficile  1/38 (2.63%)  1
Infection  3/38 (7.89%)  3
Sepsis  1/38 (2.63%)  1
Metabolism and nutrition disorders   
Tumor lysis syndrome  1/38 (2.63%)  1
Nervous system disorders   
Ataxia  1/38 (2.63%)  1
Neuropathy  3/38 (7.89%)  3
Tingling in fingertips  1/38 (2.63%)  1
Tingling in palms  1/38 (2.63%)  1
Tingling in toes  1/38 (2.63%)  1
Psychiatric disorders   
Anxiety  8/38 (21.05%)  8
Depression  2/38 (5.26%)  2
Confusion  1/38 (2.63%)  1
Renal and urinary disorders   
Bladder stone  1/38 (2.63%)  1
Dysuria  1/38 (2.63%)  2
Genitourinary obstruction  1/38 (2.63%)  1
Strong urine odor  1/38 (2.63%)  1
Urinary frequency  5/38 (13.16%)  5
Urinary retention  3/38 (7.89%)  3
Urinary tract infection  1/38 (2.63%)  1
Reproductive system and breast disorders   
Vaginal hemorrhage  1/38 (2.63%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  11/38 (28.95%)  12
Nasal congestion  3/38 (7.89%)  3
Pleural effusion  2/38 (5.26%)  2
Pneumonia  2/38 (5.26%)  2
Respiratory distress  1/38 (2.63%)  1
Tachypnea  1/38 (2.63%)  1
Upper respiratory infection  1/38 (2.63%)  1
Skin and subcutaneous tissue disorders   
Bruising  3/38 (7.89%)  3
Cellulitis  2/38 (5.26%)  2
Dry skin  2/38 (5.26%)  2
Edema  18/38 (47.37%)  21
Erythema  2/38 (5.26%)  2
Flushing  2/38 (5.26%)  2
Hives  3/38 (7.89%)  3
Itching  5/38 (13.16%)  5
Lesion  2/38 (5.26%)  2
Petechiae  2/38 (5.26%)  2
Rash  15/38 (39.47%)  16
Skin lesion  1/38 (2.63%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joanne Filicko-O'Hara, MD
Organization: Thomas Jefferson University
Phone: 215-955-8874
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT00410423     History of Changes
Other Study ID Numbers: 06U.70
2005-74 ( Other Identifier: CCRRC )
First Submitted: December 11, 2006
First Posted: December 12, 2006
Results First Submitted: September 8, 2016
Results First Posted: April 17, 2018
Last Update Posted: April 25, 2018