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The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
Patients who have relapsed myeloma have failed treatment regimens and have had disease progression following their last treatment regimen. Despite newer salvage therapies, their treatment options are limited and may include best supportive care and investigational therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without further tumor regression despite continued treatment. Recent evidence suggests that their prognosis might improve with further reduction in serum M-protein or prolongation of time to disease progression (TTP). These patients are candidates for investigational agents that could further reduce tumor burden or increase TTP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DENOSUMAB | Drug | 120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response or Partial Response Based on M-Protein Assessments Only | Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks. | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only | Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks. | Up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
Other criteria also apply.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19714603 | Background | Vij R, Horvath N, Spencer A, Taylor K, Vadhan-Raj S, Vescio R, Smith J, Qian Y, Yeh H, Jun S. An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma. Am J Hematol. 2009 Oct;84(10):650-6. doi: 10.1002/ajh.21509. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 13 February 2006 through 8 December 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab 120 mg Q4W - Plateau-Phase | Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma |
| FG001 | Denosumab 120 mg Q4W - Relapsed | Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab 120 mg Q4W - Plateau-Phase | Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma |
| BG001 | Denosumab 120 mg Q4W - Relapsed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response or Partial Response Based on M-Protein Assessments Only | Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks. | All participants who completed the first cycle of treatment with denosumab | Posted | Number | Participants | Up to 18 months |
|
up to 1 year 6 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Denosumab 120 mg Q4W - Relapsed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Complete Response Based on M-Protein Assessments Only | Complete response based on M-protein assessments, as defined for the primary outcome measure. | Up to 18 months |
| Withdrawal by Subject |
|
| Death |
|
| Disease progression |
|
| Ongoing |
|
| Other |
|
| Requirement for alternative therapy |
|
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Denosumab 120 mg Q4W - Relapsed |
Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma |
|
|
| Secondary | Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only | Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks. | All participants who completed the first cycle of treatment with denosumab | Posted | Number | Participants | Up to 18 months |
|
|
|
| Secondary | Complete Response Based on M-Protein Assessments Only | Complete response based on M-protein assessments, as defined for the primary outcome measure. | All participants who completed the first cycle of treatment with denosumab | Posted | Number | Participants | Up to 18 months |
|
|
|
| 14 |
| 53 |
| 38 |
| 53 |
| EG001 | Denosumab 120 mg Q4W - Plateau-Phase | 6 | 42 | 32 | 42 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Haemophilus infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Pneumonia streptococcal | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |