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CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Phase 3 trial testing CC-5013 in Multiple Myeloma in 353 participants. Completed in 1 October 2008.
| Lead sponsor | Celgene |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 353 |
| Start date | 1 January 2003 |
| Primary completion | 1 November 2005 |
| Estimated completion | 1 October 2008 |
| Sites | 49 locations across Canada, United States |
Celgene — full company profile →
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
| Group | Value | 95% CI |
|---|---|---|
| CC-5013/Dex | 60.1 | 41.1 – 80.0 |
| Placebo/Dex | 20.1 | 16.1 – 21.1 |
Overall survival was calculated as the time from randomization to death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| CC-5013/Dex | 170.1 | 142.1 – 204.9 |
| Placebo/Dex | 136.4 | 104.1 – 176.9 |
The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
| Group | Value | 95% CI |
|---|---|---|
| CC-5013/Dex | 107 | |
| Placebo/Dex | 34 |
The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
| Group | Value | 95% CI |
|---|---|---|
| CC-5013/Dex | 29.9 | ± 30.02 |
| Placebo/Dex | 15.0 | ± 16.98 |
Time frame: Up to 254 weeks (median=48 weeks; mean=77 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CC-5013/Dex | Placebo/Dex |
|---|---|---|---|
| PNEUMONIA | Infections and infestations | — | — |
| DEEP VEIN THROMBOSIS | Vascular disorders | — | — |
| ATRIAL FIBRILLATION | Cardiac disorders | — | — |
| DEHYDRATION | Metabolism and nutrition disorders | — | — |
| PYREXIA | General disorders | — | — |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | — | — |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | — | — |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | — | — |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | — | — |
| RENAL FAILURE | Renal and urinary disorders | — | — |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — | — |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | — | — |
| LOBAR PNEUMONIA | Infections and infestations | — | — |
| NEUTROPENIA | Blood and lymphatic system disorders | — | — |
| URINARY TRACT INFECTION | Infections and infestations | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — |
| CONVULSIONS | Nervous system disorders | — | — |
| CORONARY ARTERY DISEASE | Cardiac disorders | — | — |
| MENTAL STATUS CHANGES | Psychiatric disorders | — | — |
| RENAL FAILURE ACUTE | Renal and urinary disorders | — | — |
| SEPSIS | Infections and infestations | — | — |
| Reaction | System | CC-5013/Dex | Placebo/Dex |
|---|---|---|---|
| FATIGUE | General disorders | — | — |
| NEUTROPENIA | Blood and lymphatic system disorders | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — |
| INSOMNIA | Psychiatric disorders | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — |
| MUSCLE CRAMP | Musculoskeletal and connective tissue disorders | — | — |
| UPPER RESPIRATORY TRACT INFECTION | Respiratory, thoracic and mediastinal disorders | — | — |
| NAUSEA | Gastrointestinal disorders | — | — |
| OEDEMA PERIPHERAL | General disorders | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — |
| HEADACHE | Nervous system disorders | — | — |
| RASH | Skin and subcutaneous tissue disorders | — | — |
| PYREXIA | General disorders | — | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — | — |
| DIZZINESS | Nervous system disorders | — | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — | — |
| VISION BLURRED | Eye disorders | — | — |
| ASTHENIA | General disorders | — | — |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — |
| NASOPHARYNGITIS | Respiratory, thoracic and mediastinal disorders | — | — |
| DYSPEPSIA | Gastrointestinal disorders | — | — |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | — | — |
| TREMOR | Nervous system disorders | — | — |
| ANOREXIA | Metabolism and nutrition disorders | — | — |
| DYSGEUSIA | Nervous system disorders | — | — |
| HYPOKALAEMIA | Metabolism and nutrition disorders | — | — |
| PHARYNGITIS | Respiratory, thoracic and mediastinal disorders | — | — |
| ANXIETY | Psychiatric disorders | — | — |
| DEPRESSION | Psychiatric disorders | — | — |
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | — | — |
| PAIN IN LIMB | Musculoskeletal and connective tissue disorders | — | — |
| PERIPHERAL NEUROPATHY | Nervous system disorders | — | — |
| SINUSITIS | Infections and infestations | — | — |
| VOMITING | Gastrointestinal disorders | — | — |
| PARAESTHESIA | Nervous system disorders | — | — |
| PNEUMONIA | Infections and infestations | — | — |
| CHEST PAIN | General disorders | — | — |
| CONFUSIONAL STATE | Psychiatric disorders | — | — |
Most-reported serious reactions: PNEUMONIA, DEEP VEIN THROMBOSIS, ATRIAL FIBRILLATION, DEHYDRATION, PYREXIA, PULMONARY EMBOLISM, CEREBROVASCULAR ACCIDENT, FEBRILE NEUTROPENIA.
Data from ClinicalTrials.gov NCT00056160 adverse events section.
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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