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| 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
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Thalidomide + Dexamethasone | No text entered. |
| DOXIL + Thalidomide + Dexamethasone | No text entered. |
| 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
| Description | |
|---|---|
| Thalidomide + Dexamethasone | No text entered. |
| DOXIL + Thalidomide + Dexamethasone | No text entered. |
| 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] |
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| Female | 51 | 44 | 95 |
| Male | 62 | 68 | 130 |
Outcome Measures
| 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 ] |
| 2. Secondary: | Overall Response [ Cycle 2 until 28 days following completion of treatment ] |
| 3. Secondary: | Time to 1st Response [ Cycle 2 until 28 days following completion of treatment ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
| Description | |
|---|---|
| Thalidomide + Dexamethasone | No text entered. |
| DOXIL + Thalidomide + Dexamethasone | No text entered. |
| Thalidomide + Dexamethasone | DOXIL + Thalidomide + Dexamethasone | |
|---|---|---|
| Total, serious adverse events | ||
| # participants affected / at risk | 48/110 (43.64%) | 53/106 (50.00%) |
| Blood and lymphatic system disorders | ||
| Anaemia † A # participants affected / at risk |
2/110 (1.82%) |
3/106 (2.83%) |
| Coagulopathy † A # participants affected / at risk |
1/110 (0.91%) |
2/106 (1.89%) |
| Disseminated Intravascular Coagulation † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Febrile Neutropenia † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Pancytopenia † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Thrombocytopenia † A # participants affected / at risk |
1/110 (0.91%) |
2/106 (1.89%) |
| Neutropenia † A # participants affected / at risk |
0/110 (0.00%) |
2/106 (1.89%) |
| Cardiac disorders | ||
| Acute Myocarial Infarction † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Angina Pectoris † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Arrhythmia † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Atrial fibrillation † A # participants affected / at risk |
3/110 (2.73%) |
3/106 (2.83%) |
| Bundle Branch Block Right † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Cardiac Arrest † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Cardiac Failure Congestive † A # participants affected / at risk |
1/110 (0.91%) |
3/106 (2.83%) |
| Cardio-Respiratory Arrest † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Coronary Artery Disease † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Myocardial Infarction † A # participants affected / at risk |
2/110 (1.82%) |
1/106 (0.94%) |
| Supraventricular Tachycardia † A # participants affected / at risk |
0/110 (0.00%) |
3/106 (2.83%) |
| Gastrointestinal disorders | ||
| Abdominal Pain † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Constipation † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Duodenal Ulcer Haemorrhage † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Gastrointestinal Haemorrhage † A # participants affected / at risk |
1/110 (0.91%) |
2/106 (1.89%) |
| Gastrooesophageal Reflux Disease † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Ileus † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Intestinal Obstruction † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Large Intestine Perforation † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Nausea † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Pancreatitis † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Small Intestinal Obstruction † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Stomatitis † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Tongue Disorder † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Vomiting † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| General disorders | ||
| Asthenia † A # participants affected / at risk |
3/110 (2.73%) |
3/106 (2.83%) |
| Chest Pain † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Chills † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Disease Progression † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Fatigue † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Mass † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Mucosal Inflammation † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Non-cardiac Chest Pain † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Odema † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Odema Peripheral † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Pyrexia † A # participants affected / at risk |
1/110 (0.91%) |
4/106 (3.77%) |
| Hepatobiliary disorders | ||
| Cholelithiasis † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Infections and infestations | ||
| Abscess † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Appendicitis † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Bacteraemia † A # participants affected / at risk |
0/110 (0.00%) |
2/106 (1.89%) |
| Bacterial Infection † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Catheter related Infection † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Cellulitis † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Diverticulitus † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Enocarditis Enterococcal † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Fungal Infection † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Infection † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Oesophagael Candidiasis † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Pneumonia † A # participants affected / at risk |
5/110 (4.55%) |
7/106 (6.60%) |
| Pneumonia Pneumococcal † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Pneumonia Staphylococcal † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Sepsis † A # participants affected / at risk |
3/110 (2.73%) |
2/106 (1.89%) |
| Staphylococcal Infection † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Urinary Tract Infection † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Urosepsis † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Injury, poisoning and procedural complications | ||
| Accidental Overdose † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Compression Fracture † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Fall † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Hip Fracture † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Spinal Compression Fracture † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Investigations | ||
| Ejection Fraction Decreased † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Internation Normalised Ratio Increased † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Metabolism and nutrition disorders | ||
| Anorexia † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Dehydration † A # participants affected / at risk |
4/110 (3.64%) |
3/106 (2.83%) |
| Diabetes Mellitus † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Diabetic Ketoacidosis † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Electrolyte Imbalance † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Hyperglycaemia † A # participants affected / at risk |
7/110 (6.36%) |
1/106 (0.94%) |
| Hyperkalaemia † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Hypocalcaemia † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Hypoglycaemia † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Hypokalaemia † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Hyponatraemia † A # participants affected / at risk |
2/110 (1.82%) |
1/106 (0.94%) |
| Hypovolaemia † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Malnutrition † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Back Pain † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Joint Effusion † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Myopathy Steroid † A # participants affected / at risk |
1/110 (0.91%) |
1/106 (0.94%) |
| Pain in Extremity † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Multiple Myeloma † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Nervous system disorders | ||
| Cerebral Haemorrhage † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Cerebrovascular Accident † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Grand Mal Convulsion † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Hemiparesis † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Sleep Apnoea Syndrome † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Syncope † A # participants affected / at risk |
4/110 (3.64%) |
5/106 (4.72%) |
| Tremor † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Psychiatric disorders | ||
| Anxiety † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Psychotic Disorder † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Renal and urinary disorders | ||
| Haematuria † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Polyuria † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Renal Failure † A # participants affected / at risk |
5/110 (4.55%) |
3/106 (2.83%) |
| Renal Failure Acute † A # participants affected / at risk |
1/110 (0.91%) |
2/106 (1.89%) |
| Reproductive system and breast disorders | ||
| Vaginal Haemorrhage † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute Respiratory Distress Syndrome † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Asthma † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Bronchospasm † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Chronic Obstructive Airways Disease Exacerbated † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Chronic Obstructive Pulmonary Disease † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Cryptogenic Organising Pneumonia † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Dyspnoea † A # participants affected / at risk |
2/110 (1.82%) |
1/106 (0.94%) |
| Hypoxia † A # participants affected / at risk |
0/110 (0.00%) |
2/106 (1.89%) |
| Interstitial Lung Disease † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Pleural Effusion † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Pneumonitis † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Pulmonary Embolism † A # participants affected / at risk |
6/110 (5.45%) |
4/106 (3.77%) |
| Pulmonary Hypertension † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Respiratory Distress † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Respiratory Failure † A # participants affected / at risk |
0/110 (0.00%) |
3/106 (2.83%) |
| Skin and subcutaneous tissue disorders | ||
| Decubitus Ulcer † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Stevens-Johnson Syndrome † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Surgical and medical procedures | ||
| Arthrectomy † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Vascular disorders | ||
| Deep Vein Thrombosis † A # participants affected / at risk |
5/110 (4.55%) |
4/106 (3.77%) |
| Haematoma † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Haemorrhage † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Hypertension † A # participants affected / at risk |
2/110 (1.82%) |
1/106 (0.94%) |
| Hypotension † A # participants affected / at risk |
2/110 (1.82%) |
1/106 (0.94%) |
| Orthostatic Hypotension † A # participants affected / at risk |
1/110 (0.91%) |
0/106 (0.00%) |
| Shock † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| Thrombophlebitis † A # participants affected / at risk |
0/110 (0.00%) |
1/106 (0.94%) |
| † | Indicates events were collected by systematic assessment. |
|---|---|
| A | Term from vocabulary, MedDRA (8.1) |
Other Adverse Events
More Information
| 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:
|
| 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 |
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| No text entered. |
| 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 |
