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Low enrollment and Futility as determined by Amgen's Carfilzomib NASCR program.
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this study is to improve the clinical outcomes of research subjects with high-risk multiple myeloma in the context of the immediately preceding Total therapy 5 trial 2008-02 and Total therapy 3 trials 2003-33 and 2006-66.
Total therapy 5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission by reducing host-imposed toxicity and facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib. This will result in avoiding multiple myeloma re-growth that, we postulate, ensued in Total therapy 3 during recovery phases from severe de-conditioning. It is speculated that the incidence of positive minimal residual disease will be reduced with the addition of one cycle of consolidation therapy. The following approach will be implemented:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Therapy 5b | Experimental | Induction, optional bridging, first transplant, optional bridging, inter-therapy, optional bridging, second transplant, optional bridging, consolidation, maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myPRS | Device | Genome expression profiling used to identify high-risk and low-risk multiple myeloma |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Remission Rate for Participants With High-risk Myeloma | Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy. | from baseline to either death or study completion for each subject (up to approximately 48 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frits Van Rhee, MD, Ph.D | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33357481 | Derived | Pawlyn C. High-risk myeloma: a challenge to define and to determine the optimal treatment. Lancet Haematol. 2021 Jan;8(1):e4-e6. doi: 10.1016/S2352-3026(20)30361-6. Epub 2020 Dec 22. No abstract available. | |
| 29567784 | Derived | Davies FE, Rosenthal A, Rasche L, Petty NM, McDonald JE, Ntambi JA, Steward DM, Panozzo SB, van Rhee F, Zangari M, Schinke CD, Thanendrarajan S, Walker B, Weinhold N, Barlogie B, Hoering A, Morgan GJ. Treatment to suppression of focal lesions on positron emission tomography-computed tomography is a therapeutic goal in newly diagnosed multiple myeloma. Haematologica. 2018 Jun;103(6):1047-1053. doi: 10.3324/haematol.2017.177139. Epub 2018 Mar 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Treatment | MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2018 |
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| Induction 1 - MEL-10+CFZ-TD-PACE | Drug | Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given. Regimen: CFZ 20 mg/m2 on days 1, 5, & 6; MEL 10mg/m2 on day 3; T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 400 mg/m2/d, and E 40 mg/m2/d on days 5-8; G-CSF 10 mcg/kg/day from day 11 through end of Peripheral Blood Stem Cell (PBSC) collection. Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until 1st transplant. |
|
|
| First Transplant - MEL-80+CFZ-TD-PACE + PBSC (biologic) | Drug | Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given. Regimen: CFZ 20 mg/m2 on days -5 & -4; MEL 20 mg/m2/d, T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 100 mg/m2/d, and E 80 mg/m2/d on days -5 & -2; PBSC transplant on day 0. Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until inter-therapy. |
|
|
| Inter-Therapy - MEL-20+CFZ-TD-PACE (75%) | Drug | Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given. Regimen: CFZ 27 mg/m2 on days 1-2; MEL 5 mg/m2/d, T 200 mg/d, D 20 mg/d, P 7.5 mg/m2/d, A 7.5 mg/m2/d, C 75 mg/m2/d, and E 60 mg/m2/d on days 1-4. Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until 2nd transplant. |
|
|
| Second Transplant - MEL-80+CFZ-TD-PACE + PBSC (biologic) | Drug | Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given. Regimen: CFZ 20 mg/m2 on days -5 & -4; MEL 20 mg/m2/d, T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 100 mg/m2/d, and E 80 mg/m2/d on days -5 & -2; PBSC transplant on day 0. Optional Bridging with T 50mg/d and D 20 mg on day 1-4 every 21 days until consolidation. |
|
|
| Consolidation - CFZ-TD-PACE | Drug | Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), adriamycin (A), cyclophosphamide (C) and etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. Regimen: CFZ 27 mg/m2 on days 1-2; T 200 mg/d, D 40 mg/d, P 7.5 mg/m2/d, A 7.5 mg/m2/d, C 300 mg/m2/d, and E 30 mg/m2/d on days 1-4. |
|
|
| Maintenance - CFZ-R(T)-D | Drug | Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) and lenalidomide (R) are capsules and dexamethasone (D) is a pill; all will be taken by mouth. Regimen: For Cycles 1-12 CFZ 27 mg/m2/wk and D 12 mg/wk on days 1, 8, 15, & 22; lenalidomide (R) 15 mg/d on days 1-21. For Cycles 13-24 CFZ 27 mg/m2/wk and D 12 mg/wk on days 1, 8, 15, & 22. T may be substituted for R at 100 mg/day at the treating physician's discretion. |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Treatment | MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | 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 | The Remission Rate for Participants With High-risk Myeloma | Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy. | Nineteen (19) subjects discontinued study prior to completion. Only one (1) subject completed all study related activities. | Posted | Number | Participants | from baseline to either death or study completion for each subject (up to approximately 48 months) |
|
|
|
From baseline to either death or study completion for each subject (up to 48 months)
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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 | Study Treatment | MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy. | 4 | 20 | 13 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Syncope | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Parainfluenza | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Hematuria | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for K. Pneumonia UTI | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Neutropenic Colitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colitis / Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Leukopenia / Grade 2 | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutropenia / Grade 3 | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Uncontrolled Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Sinus Bradycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for Chest Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization Influenza | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hospitalization for L. hip pain | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myelodysplastic Snydrome (MDS) | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute Myeloid Leukemia (AML) | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wbc decrease (leukopenia) | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cardiac disorders - other | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vestibular Disorder | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Eye disorders - Other, | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Watering eyes | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other, | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastroparesis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Edema trunk | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neck edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood bilrubin increased | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Immune system disorders - Other, | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other, | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Myelitis | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sinus pain | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Creatinine increased | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other, | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatology/skin - bruising | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Social circumstances - Other, | Social circumstances | CTCAE (4.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
The study was terminated early due to futility as determined by Amgen's Carfilzomib NASCR program in addition to low enrollment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frits Van Rhee, MD | University of Arkansas for Medical Sciences | 501-526-2873 | vanrheefrits@uams.edu |
| Apr 27, 2021 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| D008558 | Melphalan |
| C524865 | carfilzomib |
| D013792 | Thalidomide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D001688 | Biological Products |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|