UARK 2012-02 Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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:
-
apply a 4-day fractionated lower dose melphalan (80 mg/m2) together with CFZ-TD-PACE regimen in MEL80-CFZ-TD (carfilzomib, thalidomide, dexamethasone) PACE as a hopefully less toxic and more effective transplant regimen
-
interspersed with 1 cycle of non-transplant supported MEL-20-CFZ-TD (carfilzomib, thalidomide, dexamethasone) PACE (in lower doses than with transplant) inter-therapy (reduced from two cycles due to prolonged thrombocytopenia)
-
followed by CFZ-TD (carfilzomib, thalidomide, dexamethasone) PACE consolidation therapy post transplant #2
-
CFZ-RD (carfilzomib, lenalidomide and dexamethasone) maintenance for 1 year followed by CFZ-D for an additional year
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Total Therapy 5b Induction, optional bridging, first transplant, optional bridging, inter-therapy, optional bridging, second transplant, optional bridging, consolidation, maintenance |
Device: myPRS
Genome expression profiling used to identify high-risk and low-risk multiple myeloma
Other Names:
Drug: Induction 1 - MEL-10+CFZ-TD-PACE
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.
Other Names:
Drug: First Transplant - MEL-80+CFZ-TD-PACE + PBSC (biologic)
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.
Other Names:
Drug: Inter-Therapy - MEL-20+CFZ-TD-PACE (75%)
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.
Other Names:
Drug: Second Transplant - MEL-80+CFZ-TD-PACE + PBSC (biologic)
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.
Other Names:
Drug: Consolidation - CFZ-TD-PACE
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.
Other Names:
Drug: Maintenance - CFZ-R(T)-D
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The Remission Rate for Participants With High-risk Myeloma [from baseline to either death or study completion for each subject (up to approximately 48 months)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must have newly diagnosed active MM requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
-
Patients must be either untreated or have not had more than one cycle of systemic MM therapy, excluding bisphosphonates and localized radiation.
-
Participants must have high-risk disease, as defined by GEP70 risk score of ≥ 0.66
-
Zubrod ≤ 2, unless solely due to symptoms of MM-related bone disease.
-
Patients must have a platelet count of ≥ 50,000/μL, unless lower levels are explained by extensive bone marrow plasmacytosis.
-
Patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
-
Participants must have preserved renal function as defined by a serum creatinine level of < 3 mg/dL.
-
Participants must have an ejection fraction by ECHO or MUGA scan ≥ 45%
-
Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. If the patient is unable to complete pulmonary function tests due to MM related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy.
-
Patients must have signed an IRB-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the IRB.
Exclusion Criteria:
-
Does not have high-risk disease
-
Poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
-
Patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds five years.
-
Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Subjects of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
Sponsors and Collaborators
- University of Arkansas
- Amgen
Investigators
- Principal Investigator: Frits Van Rhee, MD, Ph.D, University of Arkansas
Study Documents (Full-Text)
More Information
Publications
None provided.- 134668
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Study Treatment |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 20 |
| COMPLETED | 1 |
| NOT COMPLETED | 19 |
Baseline Characteristics
| Arm/Group Title | Study Treatment |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 20 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
13
65%
|
| >=65 years |
7
35%
|
| Age (years) [Median (Inter-Quartile Range) ] | |
| Median (Inter-Quartile Range) [years] |
63.5
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
50%
|
| Male |
10
50%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
4
20%
|
| White |
16
80%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
20
100%
|
Outcome Measures
| Title | The Remission Rate for Participants With High-risk Myeloma |
|---|---|
| Description | 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. |
| Time Frame | from baseline to either death or study completion for each subject (up to approximately 48 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Nineteen (19) subjects discontinued study prior to completion. Only one (1) subject completed all study related activities. |
| Arm/Group Title | Total Therapy 5B |
|---|---|
| Arm/Group Description | Induction 1 - MEL-10+CFZ-TD-PACE, Optional Bridging with TD, First Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Inter-Therapy - MEL-20+CFZ-TD-PACE (75%), Optional Bridging with TD, Second Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Consolidation - CFZ-TD-PACE, Maintenance - CFZ-R(T)-D |
| Measure Participants | 20 |
| Number [Participants] |
0
0%
|
Adverse Events
| Time Frame | From baseline to either death or study completion for each subject (up to 48 months) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Study Treatment | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Study Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/20 (20%) | |
Serious Adverse Events |
||
| Study Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 13/20 (65%) | |
| Blood and lymphatic system disorders | ||
| Hospitalization for Hematuria | 1/20 (5%) | 1 |
| Thrombocytopenia | 1/20 (5%) | 1 |
| Myelodysplastic Snydrome (MDS) | 1/20 (5%) | 1 |
| Acute Myeloid Leukemia (AML) | 1/20 (5%) | 1 |
| Cardiac disorders | ||
| Hospitalization for Syncope | 1/20 (5%) | 1 |
| Hospitalization for Sinus Bradycardia | 1/20 (5%) | 1 |
| Hospitalization for Atrial Fibrillation | 1/20 (5%) | 1 |
| Gastrointestinal disorders | ||
| Hospitalization for Neutropenic Colitis | 1/20 (5%) | 1 |
| Colitis / Grade 3 | 1/20 (5%) | 1 |
| General disorders | ||
| Hospitalization for Uncontrolled Pain | 1/20 (5%) | 1 |
| Hospitalization for Chest Pain | 1/20 (5%) | 1 |
| Immune system disorders | ||
| Leukopenia / Grade 2 | 1/20 (5%) | 1 |
| Neutropenia / Grade 3 | 4/20 (20%) | 5 |
| Injury, poisoning and procedural complications | ||
| Hospitalization for L. hip pain | 1/20 (5%) | 1 |
| Renal and urinary disorders | ||
| Acute Kidney Injury | 1/20 (5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Hospitalization for Parainfluenza | 1/20 (5%) | 1 |
| Hospitalization for K. Pneumonia UTI | 1/20 (5%) | 1 |
| Hospitalization for Shortness of Breath | 1/20 (5%) | 1 |
| Shortness of Breath | 1/20 (5%) | 1 |
| Hospitalization for Hypoxia | 1/20 (5%) | 1 |
| Hospitalization Influenza | 1/20 (5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Study Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 20/20 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 20/20 (100%) | |
| Blood and lymphatic system disorders | 7/20 (35%) | |
| Febrile neutropenia | 9/20 (45%) | |
| Lymphocyte count decreased | 20/20 (100%) | |
| Neutrophil count decreased | 19/20 (95%) | |
| Platelet count decreased | 20/20 (100%) | |
| Wbc decrease (leukopenia) | 20/20 (100%) | |
| Cardiac disorders | ||
| Atrial fibrillation | 2/20 (10%) | |
| Cardiac disorders - other | 4/20 (20%) | |
| Heart failure | 1/20 (5%) | |
| Palpitations | 1/20 (5%) | |
| Sinus bradycardia | 8/20 (40%) | |
| Sinus tachycardia | 8/20 (40%) | |
| Supraventricular tachycardia | 1/20 (5%) | |
| Ventricular tachycardia | 1/20 (5%) | |
| Ear and labyrinth disorders | ||
| Ear pain | 2/20 (10%) | |
| Hearing impaired | 2/20 (10%) | |
| Tinnitus | 1/20 (5%) | |
| Vertigo | 1/20 (5%) | |
| Vestibular Disorder | 1/20 (5%) | |
| Eye disorders | ||
| Blurred vision | 2/20 (10%) | |
| Dry eye | 1/20 (5%) | |
| Eye disorders - Other, | 1/20 (5%) | |
| Floaters | 1/20 (5%) | |
| Watering eyes | 1/20 (5%) | |
| Gastrointestinal disorders | ||
| Abdominal distension | 7/20 (35%) | |
| Abdominal pain | 5/20 (25%) | |
| Anal hemorrhage | 1/20 (5%) | |
| Bloating | 4/20 (20%) | |
| Colitis | 2/20 (10%) | |
| Colonic perforation | 1/20 (5%) | |
| Constipation | 16/20 (80%) | |
| Diarrhea | 18/20 (90%) | |
| Dry mouth | 2/20 (10%) | |
| Dyspepsia | 6/20 (30%) | |
| Dysphagia | 6/20 (30%) | |
| Enterocolitis | 1/20 (5%) | |
| Esophageal obstruction | 1/20 (5%) | |
| Esophageal pain | 1/20 (5%) | |
| Gastroesophageal reflux disease | 5/20 (25%) | |
| Gastrointestinal disorders - Other, | 4/20 (20%) | |
| Gastrointestinal pain | 1/20 (5%) | |
| Gastroparesis | 1/20 (5%) | |
| Hemorrhoids | 2/20 (10%) | |
| Mucositis oral | 7/20 (35%) | |
| Nausea | 20/20 (100%) | |
| Oral pain | 1/20 (5%) | |
| Rectal hemorrhage | 1/20 (5%) | |
| Rectal pain | 1/20 (5%) | |
| Stomach pain | 4/20 (20%) | |
| Toothache | 1/20 (5%) | |
| Vomiting | 1/20 (5%) | |
| General disorders | ||
| Chills | 8/20 (40%) | |
| Edema face | 5/20 (25%) | |
| Edema limbs | 14/20 (70%) | |
| Edema trunk | 2/20 (10%) | |
| Fatigue | 18/20 (90%) | |
| Fever | 10/20 (50%) | |
| Flu like symptoms | 2/20 (10%) | |
| Gait disturbance | 4/20 (20%) | |
| Malaise | 1/20 (5%) | |
| Neck edema | 1/20 (5%) | |
| Non-cardiac chest pain | 6/20 (30%) | |
| Pain | 11/20 (55%) | |
| Hepatobiliary disorders | ||
| Alanine aminotransferase increased | 15/20 (75%) | |
| Alkaline phosphatase increased | 16/20 (80%) | |
| Aspartate aminotransferase increased | 14/20 (70%) | |
| Blood bilrubin increased | 7/20 (35%) | |
| Hypoalbuminemia | 20/20 (100%) | |
| Immune system disorders | ||
| Allergic reaction | 1/20 (5%) | |
| Immune system disorders - Other, | 6/20 (30%) | |
| Infections and infestations | ||
| Abdominal infection | 1/20 (5%) | |
| Infections and infestations - Other, | 11/20 (55%) | |
| Lung infection | 5/20 (25%) | |
| Otitis media | 1/20 (5%) | |
| Pharyngitis | 1/20 (5%) | |
| Rhinitis infective | 7/20 (35%) | |
| Sepsis | 1/20 (5%) | |
| Sinusitis | 2/20 (10%) | |
| Skin infection | 2/20 (10%) | |
| Upper respiratory infection | 1/20 (5%) | |
| Urinary tract infection | 2/20 (10%) | |
| Injury, poisoning and procedural complications | ||
| Bruising | 1/20 (5%) | |
| Fall | 1/20 (5%) | |
| Hip fracture | 1/20 (5%) | |
| Investigations | ||
| Ejection fraction decreased | 1/20 (5%) | |
| Weight gain | 9/20 (45%) | |
| Metabolism and nutrition disorders | ||
| Anorexia | 9/20 (45%) | |
| Dehydration | 3/20 (15%) | |
| Hyperglycemia | 20/20 (100%) | |
| Hyperkalemia | 7/20 (35%) | |
| Hypermagnesemia | 3/20 (15%) | |
| Hypernatremia | 2/20 (10%) | |
| Hypocalcemia | 20/20 (100%) | |
| Hypokalemia | 16/20 (80%) | |
| Hypomagnesemia | 20/20 (100%) | |
| Hyponatremia | 20/20 (100%) | |
| Hypophosphatemia | 3/20 (15%) | |
| Tumor lysis syndrome | 1/20 (5%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthritis | 1/20 (5%) | |
| Back pain | 14/20 (70%) | |
| Bone pain | 10/20 (50%) | |
| Chest wall pain | 3/20 (15%) | |
| Generalized muscle weakness | 3/20 (15%) | |
| Joint range of motion decreased | 1/20 (5%) | |
| Muscle weakness lower limb | 1/20 (5%) | |
| Muscle weakness upper limb | 1/20 (5%) | |
| Musculoskeletal and connective tissue disorder - Other, | 5/20 (25%) | |
| Myalgia | 3/20 (15%) | |
| Neck pain | 2/20 (10%) | |
| Pain in extremity | 5/20 (25%) | |
| Nervous system disorders | ||
| Ataxia | 1/20 (5%) | |
| Dizziness | 11/20 (55%) | |
| Dysgeusia | 1/20 (5%) | |
| Dysphasia | 1/20 (5%) | |
| Facial nerve disorder | 1/20 (5%) | |
| Headache | 9/20 (45%) | |
| Myelitis | 2/20 (10%) | |
| Neuralgia | 1/20 (5%) | |
| Paresthesia | 2/20 (10%) | |
| Peripheral motor neuropathy | 3/20 (15%) | |
| Peripheral sensory neuropathy | 14/20 (70%) | |
| Presyncope | 2/20 (10%) | |
| Sinus pain | 1/20 (5%) | |
| Syncope | 2/20 (10%) | |
| Tremor | 4/20 (20%) | |
| Psychiatric disorders | ||
| Anxiety | 8/20 (40%) | |
| Confusion | 2/20 (10%) | |
| Depression | 4/20 (20%) | |
| Insomnia | 11/20 (55%) | |
| Renal and urinary disorders | ||
| Acute kidney injury | 1/20 (5%) | |
| Chronic kidney disease | 1/20 (5%) | |
| Creatinine increased | 15/20 (75%) | |
| Hematuria | 1/20 (5%) | |
| Renal and urinary disorders - Other, | 2/20 (10%) | |
| Urinary frequency | 6/20 (30%) | |
| Urinary retention | 1/20 (5%) | |
| Urinary urgency | 1/20 (5%) | |
| Reproductive system and breast disorders | ||
| Pelvic pain | 1/20 (5%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Allergic rhinitis | 12/20 (60%) | |
| Apnea | 2/20 (10%) | |
| Bronchospasm | 1/20 (5%) | |
| Cough | 12/20 (60%) | |
| Dyspnea | 11/20 (55%) | |
| Hiccups | 1/20 (5%) | |
| Hypoxia | 2/20 (10%) | |
| Laryngeal inflammation | 6/20 (30%) | |
| Laryngeal mucositis | 3/20 (15%) | |
| Laryngospasm | 1/20 (5%) | |
| Nasal congestion | 6/20 (30%) | |
| Pleural effusion | 1/20 (5%) | |
| Pleuritic pain | 1/20 (5%) | |
| Pneumothorax | 1/20 (5%) | |
| Postnasal drip | 5/20 (25%) | |
| Productive cough | 5/20 (25%) | |
| Pulmonary hypertension | 1/20 (5%) | |
| Sore throat | 6/20 (30%) | |
| Wheezing | 1/20 (5%) | |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 6/20 (30%) | |
| Dermatology/skin - bruising | 1/20 (5%) | |
| Dry skin | 4/20 (20%) | |
| Hyperhidrosis | 1/20 (5%) | |
| Pruritus | 3/20 (15%) | |
| Rash acneiform | 2/20 (10%) | |
| Rash maculo-papular | 7/20 (35%) | |
| Skin and subcutaneous tissue disorders - Other, | 3/20 (15%) | |
| Skin ulceration | 1/20 (5%) | |
| Social circumstances | ||
| Social circumstances - Other, | 5/20 (25%) | |
| Vascular disorders | ||
| Flushing | 3/20 (15%) | |
| Hot flashes | 1/20 (5%) | |
| Hypertension | 13/20 (65%) | |
| Hypotension | 14/20 (70%) | |
| Thromboembolic event | 1/20 (5%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Frits Van Rhee, MD |
|---|---|
| Organization | University of Arkansas for Medical Sciences |
| Phone | 501-526-2873 |
| vanrheefrits@uams.edu |
- 134668