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Thalidomide + Dexamethasone Versus DOXIL (Doxorubicin HCl Liposome Injection) + Thalidomide + Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
This study is ongoing, but not recruiting participants.
Study NCT00097981   Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First Received: December 1, 2004   Last Updated: September 25, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment
Conditions: Cancer
Multiple Myeloma
Interventions: Drug: Thalidomide and dexamethasone
Drug: Thalidomide and dexamethasone plus DOXIL

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Thalidomide + Dexamethasone No text entered.
DOXIL + Thalidomide + Dexamethasone No text entered.

Participant Flow:   Overall Study
  Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
STARTED   113[1]   112[2]
COMPLETED   7[3]   12[4]
NOT COMPLETED   106     100  
      Adverse Event               32                 44  
      Withdrawal by Subject               12                 9  
      Protocol Violation               5                 2  
      Death               2                 4  
      Physician Decision               7                 1  
      Transplant planned               28                 27  
      Disease Progression               8                 2  
      Sponsor Request - Study Termination               12                 11  
[1] Enrollment at randomization
[2] Enrollment at randomization
[3] Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.
[4] Completion of 2 or more cycles after CR or nCR, or completion of 12 cycles.



  Baseline Characteristics
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Reporting Groups
  Description
Thalidomide + Dexamethasone No text entered.
DOXIL + Thalidomide + Dexamethasone No text entered.

Baseline Measures
  Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone Total
Number of Participants  
[units: participants]
 		113 112 225
Age  
[units: years]
Mean ± Standard Deviation 		60 ± 10 61 ± 11 60 ± 11
Gender  
[units: participants]
 		     
Female 51 44 95
Male 62 68 130



  Outcome Measures
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1.  Primary:   Complete Response Rate Defined as the Number of Participants Who Achieve a Complete Response   [ Cycle 2 until 28 days following completion of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Overall Response   [ Cycle 2 until 28 days following completion of treatment ]
  Show Outcome Measure 2

3.  Secondary:   Time to 1st Response   [ Cycle 2 until 28 days following completion of treatment ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Thalidomide + Dexamethasone No text entered.
DOXIL + Thalidomide + Dexamethasone No text entered.

Other Adverse Events
  Thalidomide + Dexamethasone DOXIL + Thalidomide + Dexamethasone
Total, other (not including serious) adverse events    
# participants affected / at risk 110   104  
Blood and lymphatic system disorders    
Anaemia   † A
      # participants affected / at risk
21/110 (19.09%)  
31/106 (29.25%)  
Leukopenia   † A
      # participants affected / at risk
6/110 (5.45%)  
2/106 (1.89%)  
Neutropenia   † A
      # participants affected / at risk
4/110 (3.64%)  
21/106 (19.81%)  
Thrombocytopenia   † A
      # participants affected / at risk
6/110 (5.45%)  
1/106 (0.94%)  
Endocrine disorders    
Cushingoid   † A
      # participants affected / at risk
5/110 (4.55%)  
7/106 (6.60%)  
Eye disorders    
Vision Blurred   † A
      # participants affected / at risk
9/110 (8.18%)  
16/106 (15.09%)  
Gastrointestinal disorders    
Abdominal Pain   † A
      # participants affected / at risk
4/110 (3.64%)  
6/106 (5.66%)  
Constipation   † A
      # participants affected / at risk
45/110 (40.91%)  
48/106 (45.28%)  
Diarrhoea   † A
      # participants affected / at risk
15/110 (13.64%)  
16/106 (15.09%)  
Dry Mouth   † A
      # participants affected / at risk
3/110 (2.73%)  
7/106 (6.60%)  
Dyspepsia   † A
      # participants affected / at risk
10/110 (9.09%)  
6/106 (5.66%)  
Dysphagia   † A
      # participants affected / at risk
3/110 (2.73%)  
7/106 (6.60%)  
Gastrooesophageal Reflux Disease   † A
      # participants affected / at risk
5/110 (4.55%)  
8/106 (7.55%)  
Nausea   † A
      # participants affected / at risk
26/110 (23.64%)  
39/106 (36.79%)  
Stomatitis   † A
      # participants affected / at risk
4/110 (3.64%)  
14/106 (13.21%)  
Vomiting   † A
      # participants affected / at risk
13/110 (11.82%)  
15/106 (14.15%)  
General disorders    
Asthenia   † A
      # participants affected / at risk
19/110 (17.27%)  
13/106 (12.26%)  
Fatigue   † A
      # participants affected / at risk
58/110 (52.73%)  
58/106 (54.72%)  
Mucosal Inflammation   † A
      # participants affected / at risk
4/110 (3.64%)  
20/106 (18.87%)  
Oedema   † A
      # participants affected / at risk
12/110 (10.91%)  
16/106 (15.09%)  
Oedema Peripheral   † A
      # participants affected / at risk
53/110 (48.18%)  
60/106 (56.60%)  
Pyrexia   † A
      # participants affected / at risk
14/110 (12.73%)  
16/106 (15.09%)  
Infections and infestations    
Candidiasis   † A
      # participants affected / at risk
3/110 (2.73%)  
9/106 (8.49%)  
Oral Candidiasis   † A
      # participants affected / at risk
2/110 (1.82%)  
7/106 (6.60%)  
Upper Respiratory Tract Infection   † A
      # participants affected / at risk
9/110 (8.18%)  
14/106 (13.21%)  
Investigations    
International Normalized Ratio Increased   † A
      # participants affected / at risk
7/110 (6.36%)  
8/106 (7.55%)  
Weight Decreased   † A
      # participants affected / at risk
9/110 (8.18%)  
9/106 (8.49%)  
Weight Increased   † A
      # participants affected / at risk
7/110 (6.36%)  
5/106 (4.72%)  
Metabolism and nutrition disorders    
Anorexia   † A
      # participants affected / at risk
12/110 (10.91%)  
16/106 (15.09%)  
Decreased Appetite   † A
      # participants affected / at risk
9/110 (8.18%)  
10/106 (9.43%)  
Dehydration   † A
      # participants affected / at risk
10/110 (9.09%)  
10/106 (9.43%)  
Diabetes Mellitus   † A
      # participants affected / at risk
7/110 (6.36%)  
4/106 (3.77%)  
Hyperglycaemia   † A
      # participants affected / at risk
19/110 (17.27%)  
18/106 (16.98%)  
Hypocalcaemia   † A
      # participants affected / at risk
10/110 (9.09%)  
10/106 (9.43%)  
Hypokalaemia   † A
      # participants affected / at risk
13/110 (11.82%)  
11/106 (10.38%)  
Hyponatraemia   † A
      # participants affected / at risk
6/110 (5.45%)  
4/106 (3.77%)  
Musculoskeletal and connective tissue disorders    
Arthralgia   † A
      # participants affected / at risk
16/110 (14.55%)  
15/106 (14.15%)  
Back Pain   † A
      # participants affected / at risk
16/110 (14.55%)  
16/106 (15.09%)  
Bone Pain   † A
      # participants affected / at risk
5/110 (4.55%)  
9/106 (8.49%)  
Joint Swelling   † A
      # participants affected / at risk
3/110 (2.73%)  
6/106 (5.66%)  
Muscle Spasms   † A
      # participants affected / at risk
9/110 (8.18%)  
4/106 (3.77%)  
Muscular Weakness   † A
      # participants affected / at risk
12/110 (10.91%)  
10/106 (9.43%)  
Musculoskeletal Chest Pain   † A
      # participants affected / at risk
9/110 (8.18%)  
4/106 (3.77%)  
Myalgia   † A
      # participants affected / at risk
9/110 (8.18%)  
6/106 (5.66%)  
Pain in Extremity   † A
      # participants affected / at risk
14/110 (12.73%)  
13/106 (12.26%)  
Nervous system disorders    
Dizziness   † A
      # participants affected / at risk
27/110 (24.55%)  
23/106 (21.70%)  
Dysgeusia   † A
      # participants affected / at risk
10/110 (9.09%)  
16/106 (15.09%)  
Headache   † A
      # participants affected / at risk
18/110 (16.36%)  
4/106 (3.77%)  
Hypoaesthesia   † A
      # participants affected / at risk
16/110 (14.55%)  
14/106 (13.21%)  
Neuropathy   † A
      # participants affected / at risk
13/110 (11.82%)  
15/106 (14.15%)  
Neuropathy Peripheral   † A
      # participants affected / at risk
22/110 (20.00%)  
17/106 (16.04%)  
Paraesthesia   † A
      # participants affected / at risk
16/110 (14.55%)  
13/106 (12.26%)  
Peripheral Sensory Neuropathy   † A
      # participants affected / at risk
14/110 (12.73%)  
12/106 (11.32%)  
Somnolence   † A
      # participants affected / at risk
13/110 (11.82%)  
2/106 (1.89%)  
Tremor   † A
      # participants affected / at risk
20/110 (18.18%)  
22/106 (20.75%)  
Psychiatric disorders    
Anxiety   † A
      # participants affected / at risk
16/110 (14.55%)  
16/106 (15.09%)  
Confusional State   † A
      # participants affected / at risk
8/110 (7.27%)  
4/106 (3.77%)  
Depression   † A
      # participants affected / at risk
15/110 (13.64%)  
15/106 (14.15%)  
Insomnia   † A
      # participants affected / at risk
24/110 (21.82%)  
16/106 (15.09%)  
Respiratory, thoracic and mediastinal disorders    
Cough   † A
      # participants affected / at risk
11/110 (10.00%)  
10/106 (9.43%)  
Dyspnoea   † A
      # participants affected / at risk
22/110 (20.00%)  
24/106 (22.64%)  
Dyspnoea Exertional   † A
      # participants affected / at risk
5/110 (4.55%)  
6/106 (5.66%)  
Epistaxis   † A
      # participants affected / at risk
3/110 (2.73%)  
6/106 (5.66%)  
Pharyngolaryngeal Pain   † A
      # participants affected / at risk
5/110 (4.55%)  
8/106 (7.55%)  
Skin and subcutaneous tissue disorders    
Alopecia   † A
      # participants affected / at risk
3/110 (2.73%)  
7/106 (6.60%)  
Dry Skin   † A
      # participants affected / at risk
3/110 (2.73%)  
11/106 (10.38%)  
Erythema   † A
      # participants affected / at risk
7/110 (6.36%)  
7/106 (6.60%)  
Palmar-Plantar Erythrodysaesthesia Syndrome   † A
      # participants affected / at risk
3/110 (2.73%)  
39/106 (36.79%)  
Rash   † A
      # participants affected / at risk
20/110 (18.18%)  
20/106 (18.87%)  
Vascular disorders    
Deep Vein Thrombosis   † A
      # participants affected / at risk
4/110 (3.64%)  
10/106 (9.43%)  
Hypertension   † A
      # participants affected / at risk
2/110 (1.82%)  
9/106 (8.49%)  
Hypotension   † A
      # participants affected / at risk
5/110 (4.55%)  
6/106 (5.66%)  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA (8.1)


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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Director
Organization: Centocor Ortho Biotech Services, L.L.C.
e-mail: clowery1@its.jnj.com


No publications provided


Responsible Party: Ortho Biotech Products, L.P. ( Vice President Medical Affairs Oncology/Nephrology )
Study ID Numbers: CR004579
Study First Received: December 1, 2004
Results First Received: October 2, 2008
Last Updated: September 25, 2009
ClinicalTrials.gov Identifier: NCT00097981     History of Changes
Health Authority: United States: Food and Drug Administration





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