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Trial record 25 of 2571 for:    "Plasma Cell Neoplasm"

Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00523848
Recruitment Status : Completed
First Posted : September 3, 2007
Results First Posted : September 17, 2013
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Drug: bortezomib
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: thalidomide
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 - VDT: VELCADE, Doxil and Low-dose Thalidomide
Hide Arm/Group Description Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 46
Treated With Study Therapy 44
Completed 22
Not Completed 24
Reason Not Completed
Adverse Event             11
Withdrawal by Subject             2
NOT TREATED (Became ineligible)             2
Disease Progression             5
Other, unspecified             4
Arm/Group Title VDT: VELCADE, Doxil and Low-dose Thalidomide
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
Evaluable Patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
60.13  (9.34)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
14
  35.0%
Male
26
  65.0%
1.Primary Outcome
Title Overall Response Rate (Complete and Partial)
Hide Description [Not Specified]
Time Frame Every 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients
Arm/Group Title VDT: VELCADE, Doxil and Low-dose Thalidomide
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.50
(61.55 to 89.16)
2.Secondary Outcome
Title Complete Response Rate
Hide Description [Not Specified]
Time Frame Every 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable patients.
Arm/Group Title VDT: VELCADE, Doxil and Low-dose Thalidomide
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.50
(10.84 to 38.45)
3.Secondary Outcome
Title Time to Disease Progression
Hide Description [Not Specified]
Time Frame Every 3 monthsntil the date of first documented progression or date of death from any cause, whichever came first
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VDT: VELCADE, Doxil and Low-dose Thalidomide
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
27.8
(17.7 to 32.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VDT: VELCADE, Doxil and Low-dose Thalidomide
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
VDT: VELCADE, Doxil and Low-dose Thalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
VDT: VELCADE, Doxil and Low-dose Thalidomide
Affected / at Risk (%) # Events
Total   16/44 (36.36%)    
Blood and lymphatic system disorders   
Febrile neutropenia - Grade 3   1/44 (2.27%)  1
Cardiac disorders   
Bradycardia - Grade 2   1/44 (2.27%)  1
Cardiac failure congestive - Grade 3   2/44 (4.55%)  2
Sinus bradycardia - Grade 2   1/44 (2.27%)  1
Endocrine disorders   
Hypothyroidism - Grade 2   1/44 (2.27%)  1
General disorders   
Asthenia - Grade 2   1/44 (2.27%)  1
Chills - Grade 1   1/44 (2.27%)  1
Oedema peripheral - Grade 3   1/44 (2.27%)  1
Pain - Grade 2   2/44 (4.55%)  2
Pyrexia - Grade 1   2/44 (4.55%)  2
Pyrexia - Grade 2   1/44 (2.27%)  1
Pyrexia - Grade 3   1/44 (2.27%)  1
Infections and infestations   
Pneumococcal bacteraemia - Grade 3   1/44 (2.27%)  1
Pneumonia - Grade 3   6/44 (13.64%)  6
Sepsis - Grade 3   1/44 (2.27%)  1
Investigations   
Lipids abnormal - Grade 1   1/44 (2.27%)  1
Metabolism and nutrition disorders   
Cachexia - Grade 2   1/44 (2.27%)  1
Dehydration - Grade 2   2/44 (4.55%)  2
Failure to thrive - Grade 1   1/44 (2.27%)  1
Hypoalbuminaemia - Grade 1   1/44 (2.27%)  1
Metabolic acidosis - Grade 2   1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Back pain - Grade 3   1/44 (2.27%)  1
Nervous system disorders   
Headache - Grade 1   1/44 (2.27%)  1
Polyneuropathy - Grade 3   1/44 (2.27%)  1
Spinal cord compression - Grade 3   1/44 (2.27%)  1
Psychiatric disorders   
Suicide attempt - Grade 4   1/44 (2.27%)  1
Renal and urinary disorders   
Renal failure acute - Grade 2   1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea - Grade 2   1/44 (2.27%)  1
Dyspnoea - Grade 3   1/44 (2.27%)  1
Hypoxia - Grade 3   1/44 (2.27%)  1
Interstitial lung disease - Grade 3   1/44 (2.27%)  1
Pleural effusion - Grade 3   3/44 (6.82%)  3
Pleural effusion - Grade 4   1/44 (2.27%)  1
Pulmonary embolism - Grade 3   1/44 (2.27%)  1
Respiratory failure - Grade 4   1/44 (2.27%)  1
Vascular disorders   
Hypertension - Grade 2   1/44 (2.27%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VDT: VELCADE, Doxil and Low-dose Thalidomide
Affected / at Risk (%) # Events
Total   44/44 (100.00%)    
Blood and lymphatic system disorders   
Anaemia - Grade 1   8/44 (18.18%)  9
Anaemia - Grade 2   9/44 (20.45%)  9
Anaemia - Grade 3   2/44 (4.55%)  2
Leukopenia - Grade 1   19/44 (43.18%)  22
Leukopenia - Grade 2   11/44 (25.00%)  15
Leukopenia - Grade 3   7/44 (15.91%)  7
Lymphopenia - Grade 1   13/44 (29.55%)  14
Lymphopenia - Grade 2   14/44 (31.82%)  15
Lymphopenia - Grade 3   11/44 (25.00%)  11
Neutropenia - Grade 1   6/44 (13.64%)  7
Neutropenia - Grade 2   13/44 (29.55%)  16
Neutropenia - Grade 3   8/44 (18.18%)  9
Neutropenia - Grade 4   1/44 (2.27%)  1
Thrombocytopenia - Grade 1   7/44 (15.91%)  11
Thrombocytopenia - Grade 2   4/44 (9.09%)  5
Thrombocytopenia - Grade 3   2/44 (4.55%)  2
Cardiac disorders   
Bradycardia - Grade 1   3/44 (6.82%)  3
Cyanosis - Grade 1   1/44 (2.27%)  1
Tachycardia - Grade 1   1/44 (2.27%)  1
Ear and labyrinth disorders   
Deafness - Grade 1   1/44 (2.27%)  1
Deafness - Grade 2   1/44 (2.27%)  1
Ear pain - Grade 1   1/44 (2.27%)  1
Eye disorders   
Blepharitis - Grade 2   1/44 (2.27%)  1
Diplopia - Grade 1   1/44 (2.27%)  1
Dry eye - Grade 2   1/44 (2.27%)  1
Eye swelling - Grade 1   1/44 (2.27%)  1
Eyelid ptosis - Grade 2   1/44 (2.27%)  1
Lacrimation increased - Grade 1   1/44 (2.27%)  1
Meibomianitis - Grade 2   1/44 (2.27%)  1
Vision blurred - Grade 1   4/44 (9.09%)  4
Vision blurred - Grade 2   1/44 (2.27%)  1
Visual disturbance - Grade 1   1/44 (2.27%)  1
Gastrointestinal disorders   
Abdominal discomfort - Grade 1   1/44 (2.27%)  1
Abdominal distension - Grade 1   4/44 (9.09%)  4
Abdominal pain - Grade 1   1/44 (2.27%)  1
Abdominal pain upper - Grade 1   1/44 (2.27%)  1
Constipation - Grade 1   27/44 (61.36%)  27
Diarrhoea - Grade 1   10/44 (22.73%)  12
Dry mouth - Grade 1   1/44 (2.27%)  1
Dyspepsia - Grade 1   3/44 (6.82%)  3
Dysphagia - Grade 1   1/44 (2.27%)  1
Flatulence - Grade 1   1/44 (2.27%)  1
Haemorrhoids - Grade 1   1/44 (2.27%)  1
Nausea - Grade 1   10/44 (22.73%)  11
Stomatitis - Grade 1   2/44 (4.55%)  2
Vomiting - Grade 1   6/44 (13.64%)  6
General disorders   
Asthenia - Grade 1   8/44 (18.18%)  8
Asthenia - Grade 2   1/44 (2.27%)  1
Axillary pain - Grade 1   1/44 (2.27%)  1
Chest discomfort - Grade 1   1/44 (2.27%)  1
Chest pain - Grade 1   1/44 (2.27%)  1
Chills - Grade 1   4/44 (9.09%)  4
Fatigue - Grade 1   22/44 (50.00%)  24
Fatigue - Grade 2   6/44 (13.64%)  7
Fatigue - Grade 3   3/44 (6.82%)  3
Feeling hot - Grade 1   1/44 (2.27%)  1
Gait disturbance - Grade 1   3/44 (6.82%)  3
Gait disturbance - Grade 2   1/44 (2.27%)  1
Influenza like illness - Grade 1   3/44 (6.82%)  3
Non-cardiac chest pain - Grade 1   2/44 (4.55%)  2
Oedema - Grade 1   5/44 (11.36%)  5
Oedema - Grade 2   1/44 (2.27%)  1
Oedema peripheral - Grade 1   14/44 (31.82%)  15
Oedema peripheral - Grade 2   2/44 (4.55%)  2
Pain - Grade 1   4/44 (9.09%)  4
Pain - Grade 2   1/44 (2.27%)  1
Pyrexia - Grade 1   8/44 (18.18%)  8
Tenderness - Grade 1   1/44 (2.27%)  1
Xerosis - Grade 1   1/44 (2.27%)  1
Hepatobiliary disorders   
Hyperbilirubinaemia - Grade 1   1/44 (2.27%)  1
Hyperbilirubinaemia - Grade 2   1/44 (2.27%)  1
Immune system disorders   
Drug hypersensitivity - Grade 1   1/44 (2.27%)  1
Hypersensitivity - Grade 1   1/44 (2.27%)  1
Infections and infestations   
Bacterial infection - Grade 2   1/44 (2.27%)  1
Breast cellulitis - Grade 2   1/44 (2.27%)  1
Cystitis - Grade 1   1/44 (2.27%)  1
Eye infection - Grade 1   1/44 (2.27%)  1
Fungal infection - Grade 2   1/44 (2.27%)  1
Furuncle - Grade 2   1/44 (2.27%)  1
Hordeolum - Grade 1   1/44 (2.27%)  1
Infection - Grade 1   2/44 (4.55%)  2
Lobar pneumonia - Grade 2   1/44 (2.27%)  1
Localised infection - Grade 2   1/44 (2.27%)  1
Nasopharyngitis - Grade 1   3/44 (6.82%)  3
Oral candidiasis - Grade 1   2/44 (4.55%)  2
Oral candidiasis - Grade 2   1/44 (2.27%)  2
Pneumonia - Grade 1   1/44 (2.27%)  1
Pneumonia - Grade 2   4/44 (9.09%)  5
Pneumonia - Grade 3   1/44 (2.27%)  1
Rash pustular - Grade 1   1/44 (2.27%)  1
Sinusitis - Grade 1   1/44 (2.27%)  1
Tinea cruris - Grade 1   1/44 (2.27%)  1
Tinea infection - Grade 1   1/44 (2.27%)  1
Tinea pedis - Grade 2   1/44 (2.27%)  1
Upper respiratory tract infection - Grade 1   1/44 (2.27%)  1
Injury, poisoning and procedural complications   
Open wound - Grade 1   1/44 (2.27%)  1
Investigations   
Alanine aminotransferase increased - Grade 1   5/44 (11.36%)  5
Alanine aminotransferase increased - Grade 2   1/44 (2.27%)  1
Aspartate aminotransferase increased - Grade 1   14/44 (31.82%)  14
Aspartate aminotransferase increased - Grade 2   2/44 (4.55%)  2
Blood alkaline phosphatase - Grade 1   2/44 (4.55%)  2
Blood alkaline phosphatase increased - Grade 1   9/44 (20.45%)  11
Blood creatine increased - Grade 1   3/44 (6.82%)  3
Blood creatine increased - Grade 2   1/44 (2.27%)  1
Heart rate decreased - Grade 1   1/44 (2.27%)  1
Heart rate decreased - Grade 2   1/44 (2.27%)  1
International normalised ratio increased - Grade 1   1/44 (2.27%)  1
Weight decreased - Grade 1   1/44 (2.27%)  1
Weight decreased - Grade 2   1/44 (2.27%)  1
Weight decreased - Grade 3   1/44 (2.27%)  1
Weight increased - Grade 1   1/44 (2.27%)  1
Metabolism and nutrition disorders   
Anorexia - Grade 1   11/44 (25.00%)  11
Anorexia - Grade 2   1/44 (2.27%)  1
Anorexia - Grade 3   1/44 (2.27%)  1
Decreased appetite - Grade 1   2/44 (4.55%)  2
Hypercalcaemia - Grade 1   2/44 (4.55%)  2
Hypercalcaemia - Grade 2   1/44 (2.27%)  1
Hyperglycaemia - Grade 1   13/44 (29.55%)  13
Hyperglycaemia - Grade 2   3/44 (6.82%)  3
Hyperglycaemia - Grade 3   2/44 (4.55%)  2
Hyperkalaemia - Grade 1   9/44 (20.45%)  14
Hyperkalaemia - Grade 2   2/44 (4.55%)  2
Hyperkalaemia - Grade 3   1/44 (2.27%)  1
Hypernatraemia - Grade 1   8/44 (18.18%)  11
Hypernatraemia - Grade 2   1/44 (2.27%)  1
Hyperuricaemia - Grade 4   1/44 (2.27%)  1
Hypoalbuminaemia - Grade 1   4/44 (9.09%)  5
Hypoalbuminaemia - Grade 2   3/44 (6.82%)  3
Hypocalcaemia - Grade 1   11/44 (25.00%)  11
Hypocalcaemia - Grade 2   2/44 (4.55%)  2
Hypoglycaemia - Grade 1   8/44 (18.18%)  9
Hypoglycaemia - Grade 2   1/44 (2.27%)  1
Hypokalaemia - Grade 1   6/44 (13.64%)  9
Hyponatraemia - Grade 1   9/44 (20.45%)  10
Hyponatraemia - Grade 3   1/44 (2.27%)  1
Oral intake reduced - Grade 1   1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia - Grade 1   3/44 (6.82%)  4
Back pain - Grade 1   6/44 (13.64%)  6
Back pain - Grade 2   3/44 (6.82%)  3
Back pain - Grade 3   2/44 (4.55%)  2
Bone pain - Grade 1   1/44 (2.27%)  1
Bursitis - Grade 1   1/44 (2.27%)  1
Flank pain - Grade 1   1/44 (2.27%)  1
Muscle spasms - Grade 1   1/44 (2.27%)  1
Muscular weakness - Grade 1   3/44 (6.82%)  3
Musculoskeletal chest pain - Grade 1   2/44 (4.55%)  2
Musculoskeletal pain - Grade 1   3/44 (6.82%)  3
Musculoskeletal stiffness - Grade 1   2/44 (4.55%)  2
Myalgia - Grade 1   2/44 (4.55%)  2
Myalgia - Grade 2   1/44 (2.27%)  1
Pain in extremity - Grade 1   3/44 (6.82%)  3
Pain in extremity - Grade 2   2/44 (4.55%)  2
Pain in jaw - Grade 1   2/44 (4.55%)  2
Nervous system disorders   
Amnesia - Grade 1   1/44 (2.27%)  1
Balance disorder - Grade 1   1/44 (2.27%)  1
Burning sensation - Grade 1   1/44 (2.27%)  1
Cluster headache - Grade 1   1/44 (2.27%)  1
Disturbance in attention - Grade 1   1/44 (2.27%)  1
Dizziness - Grade 1   17/44 (38.64%)  22
Dizziness - Grade 2   1/44 (2.27%)  1
Dysgeusia - Grade 1   3/44 (6.82%)  3
Dysgeusia - Grade 2   1/44 (2.27%)  1
Headache - Grade 1   2/44 (4.55%)  3
Hypoaesthesia - Grade 1   2/44 (4.55%)  3
Hypoaesthesia - Grade 2   1/44 (2.27%)  1
Neuropathy - Grade 1   3/44 (6.82%)  4
Neuropathy - Grade 3   1/44 (2.27%)  1
Neuropathy peripheral - Grade 1   11/44 (25.00%)  11
Neuropathy peripheral - Grade 2   3/44 (6.82%)  3
Neuropathy peripheral - Grade 3   1/44 (2.27%)  1
Paraesthesia - Grade 1   4/44 (9.09%)  4
Parosmia - Grade 1   1/44 (2.27%)  1
Peripheral motor neuropathy - Grade 1   1/44 (2.27%)  1
Peripheral sensory neuropathy - Grade 1   1/44 (2.27%)  1
Peripheral sensory neuropathy - Grade 2   1/44 (2.27%)  1
Tremor - Grade 1   5/44 (11.36%)  5
Psychiatric disorders   
Anxiety - Grade 1   1/44 (2.27%)  2
Confusional state - Grade 2   1/44 (2.27%)  1
Confusional state - Grade 4   1/44 (2.27%)  1
Illusion - Grade 1   1/44 (2.27%)  1
Insomnia - Grade 1   1/44 (2.27%)  1
Nervousness - Grade 1   1/44 (2.27%)  1
Panic attack - Grade 1   1/44 (2.27%)  1
Sleep disorder - Grade 1   1/44 (2.27%)  1
Renal and urinary disorders   
Dysuria - Grade 1   1/44 (2.27%)  1
Pollakiuria - Grade 1   1/44 (2.27%)  1
Polyuria - Grade 1   1/44 (2.27%)  1
Renal tubular acidosis - Grade 2   1/44 (2.27%)  1
Reproductive system and breast disorders   
Pelvic pain - Grade 1   2/44 (4.55%)  2
Respiratory, thoracic and mediastinal disorders   
Cough - Grade 1   10/44 (22.73%)  10
Dysphonia - Grade 1   1/44 (2.27%)  1
Dyspnoea - Grade 1   11/44 (25.00%)  11
Dyspnoea - Grade 2   2/44 (4.55%)  2
Dyspnoea exertional - Grade 1   5/44 (11.36%)  5
Hiccups - Grade 1   1/44 (2.27%)  1
Nasal congestion - Grade 1   2/44 (4.55%)  2
Oropharyngeal swelling - Grade 1   1/44 (2.27%)  1
Productive cough - Grade 1   1/44 (2.27%)  1
Rhinorrhoea - Grade 1   2/44 (4.55%)  2
Wheezing - Grade 1   1/44 (2.27%)  1
Skin and subcutaneous tissue disorders   
Alopecia - Grade 1   1/44 (2.27%)  1
Blister - Grade 1   2/44 (4.55%)  2
Decubitus ulcer - Grade 1   1/44 (2.27%)  1
Drug eruption - Grade 1   2/44 (4.55%)  2
Drug eruption - Grade 3   1/44 (2.27%)  1
Dry skin - Grade 1   10/44 (22.73%)  10
Dry skin - Grade 2   2/44 (4.55%)  2
Erythema - Grade 1   6/44 (13.64%)  6
Erythema - Grade 2   1/44 (2.27%)  1
Hyperhidrosis - Grade 1   1/44 (2.27%)  1
Palmar-plantar erythrodysaesthesia syndrome - Grade 1   2/44 (4.55%)  2
Palmar-plantar erythrodysaesthesia syndrome - Grade 2   2/44 (4.55%)  2
Palmar-plantar erythrodysaesthesia syndrome - Grade 3   3/44 (6.82%)  3
Pigmentation disorder - Grade 1   2/44 (4.55%)  2
Pruritus - Grade 1   1/44 (2.27%)  1
Pruritus generalised - Grade 1   1/44 (2.27%)  1
Rash - Grade 1   10/44 (22.73%)  11
Rash - Grade 2   2/44 (4.55%)  2
Rash erythematous - Grade 1   6/44 (13.64%)  6
Rash erythematous - Grade 2   2/44 (4.55%)  2
Rash erythematous - Grade 3   1/44 (2.27%)  1
Rash generalised - Grade 2   1/44 (2.27%)  1
Rash morbilliform - Grade 1   1/44 (2.27%)  1
Rash pruritic - Grade 1   1/44 (2.27%)  1
Rash pruritic - Grade 2   1/44 (2.27%)  1
Rash pruritic - Grade 3   1/44 (2.27%)  1
Skin atrophy - Grade 1   1/44 (2.27%)  1
Skin discolouration - Grade 1   1/44 (2.27%)  1
Skin disorder - Grade 1   1/44 (2.27%)  1
Skin disorder - Grade 2   1/44 (2.27%)  1
Skin exfoliation - Grade 1   3/44 (6.82%)  3
Skin exfoliation - Grade 3   1/44 (2.27%)  1
Skin hyperpigmentation - Grade 1   1/44 (2.27%)  1
Skin irritation - Grade 1   1/44 (2.27%)  1
Skin lesion - Grade 1   1/44 (2.27%)  1
Urticaria - Grade 1   1/44 (2.27%)  1
Vascular disorders   
Deep vein thrombosis - Grade 3   1/44 (2.27%)  1
Hypertension - Grade 2   1/44 (2.27%)  1
Hypotension - Grade 1   1/44 (2.27%)  1
Hypotension - Grade 2   1/44 (2.27%)  1
Orthostatic hypotension - Grade 1   1/44 (2.27%)  1
Orthostatic hypotension - Grade 2   2/44 (4.55%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00523848     History of Changes
Other Study ID Numbers: CDR0000563183
RPCI-I-59105 ( Other Identifier: Roswell Park Cancer Institute )
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: July 12, 2013
Results First Posted: September 17, 2013
Last Update Posted: February 23, 2017