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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| JHOC-J0456 | |||
| JHOC-04063003 | |||
| MILLENNIUM-JHOC-J0456 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to transplantation off study. Patients who do not undergo transplantation receive 2 additional courses of therapy beyond best response for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve at least a partial response after completion of treatment may receive maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide* once daily OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in the absence of disease progression or unacceptable toxicity.
NOTE: *For patients who had previously discontinued thalidomide, maintenance therapy may consist of bortezomib only.
Quality of life is assessed at baseline, at the beginning of each study course, and after completion of study treatment.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib and Thalidomide | Experimental | The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bortezomib | Drug |
|
| |
| thalidomide |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response to Treatment | Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR. | 1-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher) | Neuropathy was monitored using Total Neuropathy Score reduced (TNSr). | 1-6 months |
| Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation |
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DISEASE CHARACTERISTICS:
Newly diagnosed Salmon-Durie stage II or III multiple myeloma
Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)
No evidence of cord compression requiring concurrent steroids
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior bortezomib
More than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks
No steroids within 14 days prior to study entry
No concurrent corticosteroids except for the treatment of a nonmalignant condition
No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery
No other concurrent investigational agents
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Borrello, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21241279 | Result | Ghosh N, Ye X, Ferguson A, Huff CA, Borrello I. Bortezomib and thalidomide, a steroid free regimen in newly diagnosed patients with multiple myeloma. Br J Haematol. 2011 Mar;152(5):593-9. doi: 10.1111/j.1365-2141.2010.08534.x. Epub 2011 Jan 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bortezomib and Thalidomide | The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide. bortezomib thalidomide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bortezomib and Thalidomide | The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide. bortezomib thalidomide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Clinical Response to Treatment | Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR. | Posted | Number | 95% Confidence Interval | percentage of participants | 1-6 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 | Bortezomib and Thalidomide | The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide. bortezomib thalidomide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dehydration | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peripheral neuropathy | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ivan Borrello | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | (410) 955-4967 | iborrell@jhmi.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 |
|---|---|
| D000069286 | Bortezomib |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Drug |
|
| 1-6 months |
| The Time to Response | 1-6 months |
| Quality of Life | 0-6 months |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide. bortezomib thalidomide |
|
|
| Secondary | Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher) | Neuropathy was monitored using Total Neuropathy Score reduced (TNSr). | Posted | Number | participants | 1-6 months |
|
|
|
| Secondary | Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation | Analysis not completed as the information was not relevant since no patients went on to transplant. | Posted | 1-6 months |
|
|
| Secondary | The Time to Response | Posted | Median | 95% Confidence Interval | months | 1-6 months |
|
|
|
| Secondary | Quality of Life | Analysis not done on subject population. | Posted | 0-6 months |
|
|
| 10 |
| 30 |
| 25 |
| 30 |
| nausea & vomiting | Gastrointestinal disorders |
|
| renal failure | Renal and urinary disorders |
|
| neutropenic fever | Infections and infestations |
|
| pneumonia | Infections and infestations |
|
| hyperkalemia | Metabolism and nutrition disorders |
|
| hypotension | Cardiac disorders |
|
| fatigue | General disorders |
|
| constipation | Gastrointestinal disorders |
|
| diarrhoea | Gastrointestinal disorders |
|
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| 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 |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| 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 |