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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
| Cephalon | INDUSTRY |
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In this study, investigators will evaluate the activity of bendamustine, bortezomib and dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma, with different mechanisms of action and non-overlapping toxicities.
The purpose of this study is to assess the efficacy, tolerability, and toxicity of bendamustine, bortezomib, and dexamethasone (BBD) as first-line treatment of multiple myeloma (MM) patients who are transplant ineligible or who are not candidates for high dose chemotherapy. Eligible patients will receive protocol treatment for up to 34 weeks plus the screening period (up to 2 weeks). Response assessments will occur every 4 weeks and confirmed using the International Myeloma Working Group Uniform Response Criteria. Patients having an objective response or stable disease will continue to maintenance therapy until disease progression or intolerable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Bendamustine, Bortezomib,and Dexamethasone for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by IMWG criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone until disease progression or intolerable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | Treatment: 80 mg/m2 via intravenous (IV) Days 1 and 2; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow. | every 8 weeks for approximately 48 months |
| Number of Patients Who Experienced Serious and Non-serious Adverse Events | All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms. | approximately 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Defined as the interval of time (in months) that patient are alive from date of first protocol treatment to date of documented tumor progression or date of death from any cause. Progressive disease, assessed according to International Myeloma Working Group Uniform Response Criteria, is defined as at least a 25% increase from the nadir in any one of the following criteria: serum M-protein, urine M-protein, or bone marrow plasma cell percentage of 10% or greater. |
Not provided
Inclusion Criteria:
Patients must meet the Durie and Salmon criteria for initial diagnosis of multiple myeloma.
Previously histologically confirmed, multiple myeloma with indication for therapy including one of the following:
Patients should not be considered candidates for high dose therapy/autologous stem cell transplantation due to coexistent medical conditions, advanced age, poor performance status, refusal of high dose chemotherapy, or other reasons as judged by the patient and/or physician.
ECOG Performance Status 0-2.
WBC ≥3000/mL; ANC ≥1000/mL; platelets ≥50,000/mL (patients with platelets ≥30,000/mL are eligible if thrombocytopenia is felt to be due to extensive bone marrow involvement with myeloma).
Patients with adequate organ function as measured by:
Renal: Serum creatinine <2.0 mg/dL or a calculated or measured creatinine clearance of >30 mL/minute.
Hepatic: Total bilirubin < 1.5 x ULN and ALT and AST <2.5 x the ULN (<5 x ULN for patients with liver involvement).
Patients must have measurable or evaluable disease. In patients with disease limited to bone and bone marrow, serial paraprotein measurements are acceptable for evaluable disease.
Patients must be accessible for treatment and follow-up procedures.
Male or female patients 18 years of age or older.
Patients must provide written informed consent prior to receiving protocol therapy.
Women of childbearing potential must agree to use a medically acceptable method of birth control(e.g., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 12 months after their last dose of rituximab. Men must use an acceptable form/method of contraception for the duration of treatment and for 3 months after the end of treatment.
Patients must be able to understand the nature of this study and give written informed consent.
Exclusion Criteria:
Previous therapy for multiple myeloma with the exception of an initial 4-day course of pulsed dexamethasone.
Patients with ≥NCI CTCAE v4.0 grade 2 peripheral neuropathy ≤14 days prior to study enrollment.
Treatment with investigational agent(s) ≤14 days prior to study enrollment.
Active infection or infection requiring intravenous antibiotic treatment at the time of accrual.
Known to be HIV positive (HIV test is not required for participation in the trial).
Patients with class III/IV cardiac problems as defined by the New York Heart Association (NYHA)criteria:
Other serious medical conditions or psychiatric illness that would potentially interfere with patient participation in this trial.
A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix,unless the tumor was treated with curative intent at least 2 years previously or low-risk prostate cancer after curative therapy.
Known hypersensitivity to bortezomib, boron, or mannitol.
Female patient is pregnant or lactating. Confirmation that female patients of childbearing potential are not pregnant must be established by a negative serum pregnancy test ≤7 days prior to start of treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Jesus Berdeja, M.D. | SCRI Development Innovations, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Robles Hospital and Medical Center | Thousand Oaks | California | 91360 | United States | ||
| Florida Cancer Specialists |
Not provided
Between May 2010 and May 2014, 59 patients with transplant-ineligible Multiple Myeloma (MM) were enrolled at 9 investigational sites in the U.S. The original treatment plan was modified during the trial to decrease intensity but increase treatment duration. Of 59 enrolled patients, 18 were treated on the initial regimen; 41 on the modified plan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Original BBD Regimen | Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy. Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period-Cycles 1-8 |
|
Not provided
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|
| Bortezomib | Drug | 1.3 mg/m2 IV Days 1, 8, 15; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response. Maintenance: 1.3 mg/m2 IV or SQ Days 1, 15 |
|
|
| Dexamethasone | Drug | 20 mg orally (PO) Days 1, 2, 8, 9, 15, 16 every 28-days for 8 cycles or 2 cycles beyond confirmed complete response, Maintenance: 20 mg PO Days 1, 15 |
|
| every 8 weeks for up to 48 months |
| Overall Survival | Defined as the interval of time, in months, from first study treatment until the earlier of the date of death or date last known alive. | every 4 weeks until progressive disease then every 12 weeks, projected 48 months |
| Overall Response Rate | The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein. | every 4 weeks for approximately 2 years |
| Fort Myers |
| Florida |
| 33916 |
| United States |
| Hematology Oncology Clinic, LLP | Baton Rouge | Louisiana | 70809 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| National Capital Clinical Research Consortium | Bethesda | Maryland | 20817 | United States |
| Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | United States |
| Oncology Hematology Care Inc. | Cincinnati | Ohio | 45242 | United States |
| South Carolina Oncology Associates | Columbia | South Carolina | 29210 | United States |
| Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Leading Edge Research, PA | Arlington | Texas | 75213 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | United States |
| FG001 | Modified BBD Regimen | Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion. Treatment: Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16 Maintenance: Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Therapy |
|
|
All patients enrolled in either the original treatment regimen or the modified treatment regimen.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Original BBD Regimen | Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy. Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4 |
| BG001 | Modified BBD Regimen | Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion. Treatment: Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16 Maintenance: Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15 |
| 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 | Median | Full Range | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Complete Response Rate | Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow. | All patients evaluable for response. | Posted | Number | percentage of participants | every 8 weeks for approximately 48 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Patients Who Experienced Serious and Non-serious Adverse Events | All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms. | All patients who received at least one dose of BBD treatment. | Posted | Number | participants | approximately 36 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Defined as the interval of time (in months) that patient are alive from date of first protocol treatment to date of documented tumor progression or date of death from any cause. Progressive disease, assessed according to International Myeloma Working Group Uniform Response Criteria, is defined as at least a 25% increase from the nadir in any one of the following criteria: serum M-protein, urine M-protein, or bone marrow plasma cell percentage of 10% or greater. | Posted | Median | Full Range | months | every 8 weeks for up to 48 months |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Defined as the interval of time, in months, from first study treatment until the earlier of the date of death or date last known alive. | All patients evaluable for response. | Posted | Median | 95% Confidence Interval | months | every 4 weeks until progressive disease then every 12 weeks, projected 48 months |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate | The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein. | All patients evaluable for response. | Posted | Number | participants | every 4 weeks for approximately 2 years |
|
every 4 weeks for up to 32 weeks on the Original BBD Regimen, or up to 2 years on the Modified BBD Regimen
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last dose of study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Original BBD Regimen | Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy. Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4 | 7 | 18 | 18 | 18 | ||
| EG001 | Modified BBD Regimen | Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion. Treatment: Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16 Maintenance: Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15 | 17 | 41 | 38 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amyloidosis | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Salivary duct obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FATIGUE | General disorders | CTCAE | Systematic Assessment |
| |
| PERIPHERAL NEUROPATHY | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| ANEMIA | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| EDEMA | General disorders | CTCAE | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| INSOMNIA | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | CTCAE | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| ASTHENIA | General disorders | CTCAE | Systematic Assessment |
| |
| FEVER | General disorders | CTCAE | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| NEUROPATHY | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| PAIN | General disorders | CTCAE | Systematic Assessment |
| |
| ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | CTCAE | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| UPPER RESPIRATORY INFECTION | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment |
| |
| WEIGHT LOSS | Investigations | CTCAE | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | CTCAE | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | CTCAE | Systematic Assessment |
| |
| TASTE ALTERATION | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| CATARACT | Eye disorders | CTCAE | Systematic Assessment |
| |
| CHEST CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| INFECTION | Infections and infestations | CTCAE | Systematic Assessment |
| |
| CREATININE LEVELS INCREASED | Investigations | CTCAE | Systematic Assessment |
| |
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE | Systematic Assessment |
| |
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| ALKALINE PHOSPHATASE INCREASED | Investigations | CTCAE | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| BRONCHIAL INFECTION | Infections and infestations | CTCAE | Systematic Assessment |
| |
| BRUISING | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| HEARING IMPAIRED | Ear and labyrinth disorders | CTCAE | Systematic Assessment |
| |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| SKIN CHANGES | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment |
| |
| THROMBOEMBOLIC EVENT | Vascular disorders | CTCAE | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Renal and urinary disorders | CTCAE | Systematic Assessment |
| |
| CHEST PAIN | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment |
| |
| NASAL DRAINAGE | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| PARESTHESIA | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | CTCAE | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | CTCAE | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| BLURRED VISION | Eye disorders | CTCAE | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
| |
| FLU LIKE SYMPTOMS | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAE | Systematic Assessment |
| |
| THRUSH | Infections and infestations | CTCAE | Systematic Assessment |
| |
| CHILLS | General disorders | CTCAE | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | CTCAE | Systematic Assessment |
| |
| URINARY FREQUENCY | Renal and urinary disorders | CTCAE | Systematic Assessment |
| |
| ALLERGIC REACTION | Immune system disorders | CTCAE | Systematic Assessment |
| |
| MUCOSITIS | Gastrointestinal disorders | CTCAE | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Davis, RAC | Sarah Cannon Development Innovations | charles.davis2@scri-innovations.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 |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Physician Decision |
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| Withdrawal by Subject |
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| Intercurrent Illness |
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| Continuing maintenance therapy |
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| male |
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| unknown |
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| Asian |
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| Black/African American |
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| Caucasian |
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| White |
|
| Unknown |
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