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This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic acid | Experimental | Participants received 4 milligrams (mg) or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes, every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine N-telopeptide of type 1 collagen (NTx) measurement (greater than or equal to [≥] 50 nanomoles per millimoles [nmol/mmol] creatinine or <50 nmol/mmol creatinine, respectively). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug | Zoledronic acid concentrate (4 mg/5 milliliters [ml]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥1 SRE at the End of 1 Year on Study | SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First SRE on Study | The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriValley Cancer Research and Treatment Center | Casa Grande | Arizona | 85222 | United States | ||
| Wilshire Oncology Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26644410 | Result | Raje N, Vescio R, Montgomery CW, Badros A, Munshi N, Orlowski R, Hadala JT, Warsi G, Argonza-Aviles E, Ericson SG, Anderson KC. Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study. Clin Cancer Res. 2016 Mar 15;22(6):1378-84. doi: 10.1158/1078-0432.CCR-15-1864. Epub 2015 Dec 7. |
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A total of 121 participants with Advanced Multiple Myeloma were enrolled in this study. By study design, any participants who had a Skeletal-related Event (SRE) in Zoledronic Acid Every 12 Weeks group was switched to Zoledronic Acid Every 4 Weeks or 12 Weeks group and reported as Zoledronic Acid Every 4 Weeks or 12 Weeks group, respectively.
This study was conducted at 67 centers in the United States (US) from 07 November 2007 to 03 April 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid Every 12 Weeks | Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( <50 nmol/mmol creatinine). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Up to 2 years |
| Percentage of Participants Who Experienced Pathologic Bone Fracture | Pathologic bone fractures are defined as bone fractures that occur spontaneously or as a result of trivial trauma. | Years 1 and 2 |
| Percentage of Participants Who Experienced Spinal Cord Compression | Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain. | Years 1 and 2 |
| Percentage of Participants Who Experienced Radiation to Bone | Radiation therapy to bone events includes irradiation of bone to palliate painful lesions, to treat or prevent pathologic fractures, or to treat or prevent spinal cord compression. | Years 1 and 2 |
| Percentage of Participants Who Experienced Surgery to Bone | Surgery to bone events includes surgical procedures that are performed to set or stabilize pathologic fractures or areas of spinal cord compression and surgical procedures that are performed to prevent an imminent pathologic fracture or spinal cord compression. | Years 1 and 2 |
| Percentage of Participants Who Experienced HCM | HCM is defined as corrected serum calcium ≥ 12.0 milligrams per deciliter (mg/dL) (3.00 millimoles per liter [mmol/L]), or a lower level of hypercalcemia that was symptomatic and required active treatment other than rehydration. | Years 1 and 2 |
| Skeletal Related Event (SRE) Rate | The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. | Years 1 and 2 |
| Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx) | uNTx is a biomarker used to measure the rate of bone turnover found in urine. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS) |
| Time to Death | Time to death was defined as the time from the date of enrollment to the date of death. Participants who dropped out or completed the study were considered censored observations. Time to death was assessed by Kaplan-Meier method. | Up to 2 years |
| La Verne |
| California |
| 91750 |
| United States |
| Cedars Sinai Medical Center Outpatient Cancer Ctr. (4) | Los Angeles | California | 90048 | United States |
| Palo Alto Medical Foundation Hematology/Oncology | Mountain View | California | 94040 | United States |
| Oncology Care Medical Associates | San Gabriel | California | 91776 | United States |
| Santa Clara Valley Health & Hospital System | San Jose | California | 95128 | United States |
| University of Colorado U of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Hematology Oncology PC | Stamford | Connecticut | 06902 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Palm Beach Institute of Hematology Oncology | Boynton Beach | Florida | 33435 | United States |
| Innovative Medical Research of South Florida Innovative Med Research | Miami Shores | Florida | 33138 | United States |
| Cancer Centers of Florida PA Cancer Centers of Central FL | Ocoee | Florida | *see dep* | United States |
| Integrated Community Oncology Network Florida Oncology Associates | Orange Park | Florida | 32073 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr | Maywood | Illinois | 60153 | United States |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Center for Cancer & Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Oncology - Hematology Associates, PA Oncology Hematology Assoc | Clinton | Maryland | 20735 | United States |
| Dana Farber Cancer Institute Clinical Research Coordinator | Boston | Massachusetts | 02115 | United States |
| Boston VA Healthcare Boston VA | Boston | Massachusetts | 02131 | United States |
| Berkshire Hematology Oncology | Pittsfield | Massachusetts | 01201-8298 | United States |
| N MS Hematology & Oncology | Tupelo | Mississippi | 38801 | United States |
| Hematology & Oncology Consultants, PC Hematology & Oncology | Omaha | Nebraska | 68122-1799 | United States |
| Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2) | Somerset | New Jersey | 08873 | United States |
| Cooper Cancer Center | Voorhees Township | New Jersey | 08043 | United States |
| Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center | Rochester | New York | 14621 | United States |
| University of Rochester MC / James P. Wilmot Cancer Center James P. Wilmot Cancer Center | Rochester | New York | 14642 | United States |
| SUNY - Upstate Medical University Div. of Hematology-Oncology | Syracuse | New York | 13210 | United States |
| Carolina Oncology Specialists, PC | Hickory | North Carolina | 28602 | United States |
| Regional Hematology-Oncology Associates PC | Langhorne | Pennsylvania | 19047 | United States |
| Temple University Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Medical Associates, PA | Charleston | South Carolina | 29403 | United States |
| Low Country Hematology Oncology Dept of Lowcountry Hem/Onc | Mt. Pleasant | South Carolina | 29464 | United States |
| Lexington Oncology Associates | West Columbia | South Carolina | 29169 | United States |
| Avera Research Institute | Sioux Falls | South Dakota | 57105 | United States |
| Blood and Cancer Center of East Texas | Tyler | Texas | 75701 | United States |
| East Texas Medical Center Cancer Institute | Tyler | Texas | 75701 | United States |
| Northern Utah Cancer Associates Dept.ofNorthernUtahAssoc. | Ogden | Utah | 84403-3105 | United States |
| Central Utah Clinic Central Utah Clinic (8) | Provo | Utah | 84604 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| West Virginia University Health Research Center Clinical Trial Research Unit | Morgantown | West Virginia | 26506 | United States |
| Zoledronic Acid Every 4 Weeks or 12 Weeks |
Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or <50 nmol/mmol creatinine, respectively). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) analysis set included all participants who were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid Every 12 Weeks | Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( <50 nmol/mmol creatinine). |
| BG001 | Zoledronic Acid Every 4 Weeks or 12 Weeks | Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or <50 nmol/mmol creatinine, respectively). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With ≥1 SRE at the End of 1 Year on Study | SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys. | ITT analysis set included all participants who were enrolled in this study. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Time to First SRE on Study | The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method. | ITT analysis set included all participants who were enrolled in this study. | Posted | Median | 95% Confidence Interval | years | Up to 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Pathologic Bone Fracture | Pathologic bone fractures are defined as bone fractures that occur spontaneously or as a result of trivial trauma. | ITT analysis set included all participants who were enrolled in the study. Number analyzed signifies the number of participants with data available for analysis at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Years 1 and 2 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Spinal Cord Compression | Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain. | ITT analysis set included all participants who were enrolled in the study. Number analyzed signifies the number of participants with data available for analysis at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Years 1 and 2 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Radiation to Bone | Radiation therapy to bone events includes irradiation of bone to palliate painful lesions, to treat or prevent pathologic fractures, or to treat or prevent spinal cord compression. | ITT analysis set included all participants who were enrolled in the study. Number analyzed signifies the number of participants with data available for analysis at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Years 1 and 2 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Surgery to Bone | Surgery to bone events includes surgical procedures that are performed to set or stabilize pathologic fractures or areas of spinal cord compression and surgical procedures that are performed to prevent an imminent pathologic fracture or spinal cord compression. | ITT analysis set includes all participants who were enrolled in this study. Number analyzed signifies the number of participants with data available for analysis at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Years 1 and 2 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced HCM | HCM is defined as corrected serum calcium ≥ 12.0 milligrams per deciliter (mg/dL) (3.00 millimoles per liter [mmol/L]), or a lower level of hypercalcemia that was symptomatic and required active treatment other than rehydration. | ITT analysis set includes all participants who were enrolled in this study. Number analyzed signifies the number of participants with data available for analysis at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Years 1 and 2 |
| ||||||||||||||||||||||||||||||
| Secondary | Skeletal Related Event (SRE) Rate | The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. | ITT analysis set includes all participants who were enrolled in this study. Number analyzed signifies the number of participants with data available for analysis at given time point. | Posted | Mean | Standard Deviation | number of SRE/total follow-up time | Years 1 and 2 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx) | uNTx is a biomarker used to measure the rate of bone turnover found in urine. | Safety analysis set included all enrolled participants who received at least 1 dose of zoledronic acid. Number analyzed signifies the number of participants with data available for analysis at given time point. | Posted | Mean | Standard Deviation | nmol/mmol creatinine | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS) |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Death | Time to death was defined as the time from the date of enrollment to the date of death. Participants who dropped out or completed the study were considered censored observations. Time to death was assessed by Kaplan-Meier method. | ITT analysis set included all participants who were enrolled in this study. | Posted | Median | 95% Confidence Interval | years | Up to 2 years |
|
|
Up to 2 Years
Safety analysis set included all enrolled participants who received at least 1 dose of zoledronic acid. Number analyzed signifies the number of participants with data available for analysis at given time point.
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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 | Zoledronic Acid Every 12 Weeks | Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement ( <50 nmol/mmol creatinine). | 2 | 79 | 23 | 79 | 70 | 79 |
| EG001 | Zoledronic Acid Every 4 Weeks or 12 Weeks | Participants received 4 mg or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine NTx measurement (≥ 50 nmol/mmol creatinine or <50 nmol/mmol creatinine, respectively). | 2 | 42 | 25 | 42 | 41 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Ventricular asystole | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Leukaemia plasmacytic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (unspecified) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (unspecified) | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (unspecified) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (unspecified) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (unspecified) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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