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| ID | Type | Description | Link |
|---|---|---|---|
| H-2004-0064 | Other Identifier | Institutional Review Board | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison | |
| NCI-2011-00516 | Registry Identifier | NCI Trial ID |
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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
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Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.
The primary objective of this study is to assess overall response rate to the treatment.
Secondary objectives include: evaluating and describing the incidence of chemotherapy-induced peripheral neuropathy using the FACT/GOG-Ntx assessment tool; evaluating the utility of adding ALCAR to the chemotherapy to reduce the incidence of peripheral neuropathy; and evaluating the utility of the Grooved Pegboard Completion Time as a longitudinal measure of peripheral neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bort, Dex, and Dox with ALCAR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bort, Dex, and Dox with ALCAR | Drug | Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR | Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner. Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy. Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis. | Every 21 days, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From date of randomization until the date of death from any cause, assessed up to 7 years | |
| Progression-free Survival | Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie S Callander, MD | UWCCC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Health Systems | Janesville | Wisconsin | United States | |||
| Gundersen Lutheran |
No events between enrollment and group assignment. All subjects are enrolled are assigned to the same group.
Participants were recruited from University of Wisconsin Hospital and Clinics and the Wisconsin Oncology Network between April 2004 and September 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bort, Dex, and Dox With ALCAR | Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bort, Dex, and Dox With ALCAR | Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR | Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner. Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy. Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis. | Posted | Number | 90% Confidence Interval | percentage of participants | Every 21 days, up to 24 weeks |
|
Adverse Events were collected while subjects were receiving study treatment through 30 days post last dose of study treatment, up to 28 weeks.
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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 | Bort, Dex, and Dox With ALCAR | Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis/embolism - DVT | Vascular disorders | CTCAE version 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | CTCAE version 3 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natalie Callander | University of Wisconsin Hospital and Clinics | 608-265-8690 | nsc@medicine.wisc.edu |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D000108 | Acetylcarnitine |
| D000069286 | Bortezomib |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years. |
| La Crosse |
| Wisconsin |
| United States |
| University of Wisconsin Cancer Center | Madison | Wisconsin | 53792 | United States |
| Regional Cancer Center | Waukesha/Oconomowoc | Wisconsin | United States |
| Aspirus Wausau Hospital, Aspirus Regional Cancer Center | Wausau | Wisconsin | United States |
| Physician Decision |
|
| Other Complicating Disease |
|
| Started Non-Protocol Therapy |
|
| Withdrawal by Subject |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Overall Survival | Posted | Median | Full Range | months | From date of randomization until the date of death from any cause, assessed up to 7 years |
|
|
|
| Secondary | Progression-free Survival | Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray. | Posted | Median | Full Range | months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years. |
|
|
|
| 10 |
| 32 |
| 32 |
| 32 |
| Fever (in the absence of neutropenia) | General disorders | CTCAE version 3 |
|
| CNS Hemorrhage/bleeding | Nervous system disorders | CTCAE version 3 |
|
| Hemorrhage - Other, specify: GI-esophagus | Gastrointestinal disorders | CTCAE version 3 |
|
| Febrile neutropenia - pneumonia | Infections and infestations | CTCAE version 3 |
|
| Infection with unknown ANC | Infections and infestations | CTCAE version 3 |
|
| Infection without Neutropenia | Infections and infestations | CTCAE version 3 |
|
| Infection/Febrile Neutropenia | Infections and infestations | CTCAE version 3 |
|
| Infection/Febrile Neutropenia - Other, specify: Normal ANC, Gr 1 or 2 neutrophils | Infections and infestations | CTCAE version 3 |
|
| Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCAE version 3 |
|
| Neurology - Other, specify: encephalopathy | Nervous system disorders | CTCAE version 3 |
|
| Neurology - Other, specify: vocal cord paralysis | Nervous system disorders | CTCAE version 3 |
|
| Seizure | Nervous system disorders | CTCAE version 3 |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 |
|
| Alkaline phosphatase increased | Investigations | CTCAE version 3 |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE version 3 |
|
| Anemia | Blood and lymphatic system disorders | CTCAE version 3 |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE version 3 |
|
| back pain | Musculoskeletal and connective tissue disorders | CTCAE version 3 |
|
| Bloating | Gastrointestinal disorders | CTCAE version 3 |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE version 3 |
|
| Blurred vision | Eye disorders | CTCAE version 3 |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE version 3 |
|
| Colitis | Gastrointestinal disorders | CTCAE version 3 |
|
| Confusion | Psychiatric disorders | CTCAE version 3 |
|
| Constipation | Gastrointestinal disorders | CTCAE version 3 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 |
|
| Creatine increased | Investigations | CTCAE version 3 |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE version 3 |
|
| Diarrhea | Gastrointestinal disorders | CTCAE version 3 |
|
| Dizziness | Nervous system disorders | CTCAE version 3 |
|
| Dysphagia | Gastrointestinal disorders | CTCAE version 3 |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 |
|
| Edema limbs | General disorders | CTCAE version 3 |
|
| Extrapyramidal involuntary movement | Nervous system disorders | CTCAE version 3 |
|
| Fatigue | General disorders | CTCAE version 3 |
|
| Fever | General disorders | CTCAE version 3 |
|
| Headache | Nervous system disorders | CTCAE version 3 |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 3 |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE version 3 |
|
| Hypertension | Vascular disorders | CTCAE version 3 |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE version 3 |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE version 3 |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 3 |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 3 |
|
| Hypotension | Vascular disorders | CTCAE version 3 |
|
| Infections and infestations other, specify: with or without neutropenia | Infections and infestations | CTCAE version 3 |
|
| Insomnia | Psychiatric disorders | CTCAE version 3 |
|
| LDH | Investigations | CTCAE version 3 |
|
| Lymphocyte count decrease | Investigations | CTCAE version 3 |
|
| Metabolic changes | Metabolism and nutrition disorders | CTCAE version 3 |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | CTCAE version 3 |
|
| Musculoskeletal and connective tissue disorder- other, specify: Joint pain | Musculoskeletal and connective tissue disorders | CTCAE version 3 |
|
| Nausea | Gastrointestinal disorders | CTCAE version 3 |
|
| Neuropathic pain | Nervous system disorders | CTCAE version 3 |
|
| Neutrophil count decreased | Investigations | CTCAE version 3 |
|
| Oral pain | Gastrointestinal disorders | CTCAE version 3 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE version 3 |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE version 3 |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 3 |
|
| Platelet count decreased | Investigations | CTCAE version 3 |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 3 |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 3 |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE version 3 |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE version 3 |
|
| Sweating | Skin and subcutaneous tissue disorders | CTCAE version 3 |
|
| Taste Alteration | Gastrointestinal disorders | CTCAE version 3 |
|
| Upper respiratory infection | Infections and infestations | CTCAE version 3 |
|
| Urinary frequency | Renal and urinary disorders | CTCAE version 3 |
|
| Vomiting | Gastrointestinal disorders | CTCAE version 3 |
|
| Weight loss | Investigations | CTCAE version 3 |
|
| White blood cell decreased | Investigations | CTCAE version 3 |
|
Not provided
Not provided
| 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002331 | Carnitine |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |