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The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects.
Recently laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called "anti-angiogenesis" It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thalidomide + Bisphosphonate | Experimental | 200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamidronate | Drug | Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response | Best response to study treatment as defined by protocol-specific response criteria: Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (>20%) with <1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by > 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to <5%; Decrease in Bence-Jones proteinuria by >90%; No new lytic bone lesions or soft tissue plasmacytoma. Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bart Barlogie, MD, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences/MIRT | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18669874 | Derived | Barlogie B, van Rhee F, Shaughnessy JD Jr, Epstein J, Yaccoby S, Pineda-Roman M, Hollmig K, Alsayed Y, Hoering A, Szymonifka J, Anaissie E, Petty N, Kumar NS, Srivastava G, Jenkins B, Crowley J, Zeldis JB. Seven-year median time to progression with thalidomide for smoldering myeloma: partial response identifies subset requiring earlier salvage therapy for symptomatic disease. Blood. 2008 Oct 15;112(8):3122-5. doi: 10.1182/blood-2008-06-164228. Epub 2008 Jul 31. |
| Label | URL |
|---|---|
| Myeloma Institute for Research \& Therapy | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thalidomide + Bisphosphonate | 200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy Thalidomide: All Patients will receive thalidomide 200 mg as an oral once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose) Pamidronate: Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy. Zometa: Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Dise |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thalidomide + Bisphosphonate | 200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy |
| 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 | Best Response | Best response to study treatment as defined by protocol-specific response criteria: Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (>20%) with <1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by > 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to <5%; Decrease in Bence-Jones proteinuria by >90%; No new lytic bone lesions or soft tissue plasmacytoma. Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease. | Posted | Number | participants | 2 years |
|
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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 | Thalidomide + Bisphosphonate | 200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis/infiltrates | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 1 Allergic rhinitis | Immune system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bart Barlogie | UAMS Myeloma Institute | 526-6990 | 2420 | barlogiebart@uams.edu |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077268 | Pamidronate |
| D013792 | Thalidomide |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| Thalidomide | Drug | All Patients will receive thalidomide 200 mg as an oral, once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose) |
|
| Zometa | Drug | Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy |
|
|
| 16 |
| 83 |
| 83 |
| 83 |
| Cardiovascular-other | Cardiac disorders |
|
| Joint, muscle, bone-other | Musculoskeletal and connective tissue disorders |
|
| Lung-other | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory infect w/o neutrop | Respiratory, thoracic and mediastinal disorders |
|
| Diarrhea without colostomy | Gastrointestinal disorders |
|
| Fatigue/malaise/lethargy | General disorders |
|
| Syncope | Cardiac disorders |
|
| Confusion | Psychiatric disorders |
|
| Speech impairment | General disorders |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| GI-other | Gastrointestinal disorders |
|
| Grade 1 Anemia | Blood and lymphatic system disorders |
|
| Grade 2 Anemia | Blood and lymphatic system disorders |
|
| Grade 1 Neutropenia/granulocytopenia | Blood and lymphatic system disorders |
|
| Grade 2 Neutropenia/granulocytopenia | Blood and lymphatic system disorders |
|
| Grade 1 Thrombocytopenia | Blood and lymphatic system disorders |
|
| Grade 2 Thrombocytopenia | Blood and lymphatic system disorders |
|
| Grade 3 Thrombocytopenia | Blood and lymphatic system disorders |
|
| Grade 2 Leukopenia | Blood and lymphatic system disorders |
|
| Grade 1 Arrhythmia, NOS | Cardiac disorders |
|
| Grade 4 Cardiovascular - other | Cardiac disorders |
|
| Grade 1 Edema | Cardiac disorders |
|
| Grade 2 Edema | Cardiac disorders |
|
| Grade 1 Hypertension | Cardiac disorders |
|
| Grade 2 Hypertension | Cardiac disorders |
|
| Grade 1 Sinus bradycardia | Cardiac disorders |
|
| Grade 2 Sinus bradycardia | Cardiac disorders |
|
| Grade 1 Fatigue | General disorders |
|
| Grade 2 Fatigue | General disorders |
|
| Grade 3 Fatigue | General disorders |
|
| Grade 1 Fever without neutropenia | General disorders |
|
| Grade 2 Fever without neutropenia | General disorders |
|
| Grade 1 Fever, NOS | General disorders |
|
| Grade 2 Fever, NOS | General disorders |
|
| Grade 2 Sweating | General disorders |
|
| Grade 1 weight gain | General disorders |
|
| Grade 2 weight gain | General disorders |
|
| Grade 1 weight loss | General disorders |
|
| Grade 1 Dry skin | Skin and subcutaneous tissue disorders |
|
| Grade 1 Erythema/rash/eruption/desquamation | Skin and subcutaneous tissue disorders |
|
| Grade 2 Erythema/rash/eruption/desquamation | Skin and subcutaneous tissue disorders |
|
| Grade 1 Rash/desquamation | Skin and subcutaneous tissue disorders |
|
| Grade 2 Rash/desquamation | Skin and subcutaneous tissue disorders |
|
| Grade 1 Skin - other | Skin and subcutaneous tissue disorders |
|
| Grade 2 Skin - other | Skin and subcutaneous tissue disorders |
|
| Grade 1 Anorexia | Gastrointestinal disorders |
|
| Grade 2 Anorexia | Gastrointestinal disorders |
|
| Grade 2 Constipation | Gastrointestinal disorders |
|
| Grade 1 Constipation/bowel obstruction | Gastrointestinal disorders |
|
| Grade 2 Constipation/bowel obstruction | Gastrointestinal disorders |
|
| Grade 3 Constipation/bowel obstruction | Gastrointestinal disorders |
|
| Grade 1 Diarrhea without colostomy | Gastrointestinal disorders |
|
| Grade 2 Diarrhea without colostomy | Gastrointestinal disorders |
|
| Grade 1 GI - other | Gastrointestinal disorders |
|
| Grade 1 Mouth dryness | Gastrointestinal disorders |
|
| Grade 2 Mouth dryness | Gastrointestinal disorders |
|
| Grade 1 Nausea | Gastrointestinal disorders |
|
| Grade 2 Nausea | Gastrointestinal disorders |
|
| Grade 1 Vomiting | Gastrointestinal disorders |
|
| Grade 1 Alkaline phosphatase increase | Hepatobiliary disorders |
|
| Grade 1 Hypoalbuminemia | Hepatobiliary disorders |
|
| Grade 2 Hypoalbuminemia | Hepatobiliary disorders |
|
| Grade 1 SGOT (AST) increase | Hepatobiliary disorders |
|
| Grade 1 SGPT (ALT) increase | Hepatobiliary disorders |
|
| Grade 1 Infection w/o 3-4 neutropenia | Infections and infestations |
|
| Grade 2 Infection w/o 3-4 neutropenia | Infections and infestations |
|
| Grade 2 Respiratory infect w/o neutrop | Infections and infestations |
|
| Grade 1 Bicarbonate decrease | Metabolism and nutrition disorders |
|
| Grade 1 Hypercalcemia | Metabolism and nutrition disorders |
|
| Grade 1 Hyperglycemia | Metabolism and nutrition disorders |
|
| Grade 2 Hyperglycemia | Metabolism and nutrition disorders |
|
| Grade 3 Hyperglycemia | Metabolism and nutrition disorders |
|
| Grade 1 Hypocalcemia | Metabolism and nutrition disorders |
|
| Grade 2 Hypocalcemia | Metabolism and nutrition disorders |
|
| Grade 1 Hypokalemia | Metabolism and nutrition disorders |
|
| Grade 1 Hypomagnesemia | Metabolism and nutrition disorders |
|
| Grade 1 Hyponatremia | Metabolism and nutrition disorders |
|
| Grade 3 Hyponatremia | Metabolism and nutrition disorders |
|
| Grade 2 Hypophosphatemia | Metabolism and nutrition disorders |
|
| Grade 3 Hypophosphatemia | Metabolism and nutrition disorders |
|
| Grade 2 Arthritis | Musculoskeletal and connective tissue disorders |
|
| Grade 1 Joint, muscle, bone - other | Musculoskeletal and connective tissue disorders |
|
| Grade 2 Joint, muscle, bone - other | Musculoskeletal and connective tissue disorders |
|
| Grade 3 Joint, muscle, bone - other | Musculoskeletal and connective tissue disorders |
|
| Grade 1 Muscle Weakness (not neuro) | Musculoskeletal and connective tissue disorders |
|
| Grade 2 Muscle Weakness (not neuro) | Musculoskeletal and connective tissue disorders |
|
| Grade 1 Anxiety/agitation | Psychiatric disorders |
|
| Grade 2 Anxiety/agitation | Psychiatric disorders |
|
| Grade 1 Ataxia | Nervous system disorders |
|
| Grade 1 Confusion | Psychiatric disorders |
|
| Grade 2 Confusion | Psychiatric disorders |
|
| Grade 1 Cranial neuropathy | Nervous system disorders |
|
| Grade 1 Depression | Psychiatric disorders |
|
| Grade 2 Depression | Psychiatric disorders |
|
| Grade 1 Dizziness/light headedness | Nervous system disorders |
|
| Grade 2 Dizziness/light headedness | Nervous system disorders |
|
| Grade 3 Dizziness/light headedness | Nervous system disorders |
|
| Grade 1 Headache | General disorders |
|
| Grade 2 Headache | General disorders |
|
| Grade 1 Insomnia | Psychiatric disorders |
|
| Grade 2 Insomnia | Psychiatric disorders |
|
| Grade 1 Memory loss | Psychiatric disorders |
|
| Grade 1 Mood/consciousness change, NOS | Psychiatric disorders |
|
| Grade 1 Neuro - other | Nervous system disorders |
|
| Grade 2 Neuro - other | Nervous system disorders |
|
| Grade 1 Sensory neuropathy | Nervous system disorders |
|
| Grade 2 Sensory neuropathy | Nervous system disorders |
|
| Grade 3 Sensory neuropathy | Nervous system disorders |
|
| Grade 1 Somnolence/consciousness loss | General disorders |
|
| Grade 2 Somnolence/consciousness loss | General disorders |
|
| Grade 3 Somnolence/consciousness loss | General disorders |
|
| Grade 1 Tremor | Nervous system disorders |
|
| Grade 2 Tremor | Nervous system disorders |
|
| Grade 1 Weakness (motor neuropathy) | Nervous system disorders |
|
| Grade 2 Weakness (motor neuropathy) | Nervous system disorders |
|
| Grade 3 Weakness (motor neuropathy) | Nervous system disorders |
|
| Grade 2 Blurred vision | Eye disorders |
|
| Grade 1 Eye - other | Eye disorders |
|
| Grade 1 Bone Pain | General disorders |
|
| Grade 2 Bone Pain | General disorders |
|
| Grade 3 Bone Pain | General disorders |
|
| Grade 1 Chest pain, not cardio or pleural | General disorders |
|
| Grade 2 Lower Back | General disorders |
|
| Grade 1 Pain - other | General disorders |
|
| Grade 2 Pain - other | General disorders |
|
| Grade 3 Pain - other | General disorders |
|
| Grade 1 Upper Back | General disorders |
|
| Grade 1 Cough | Respiratory, thoracic and mediastinal disorders |
|
| Grade 2 Cough | Respiratory, thoracic and mediastinal disorders |
|
| Grade 2 Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Grade 3 Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Grade 3 Pneumonitis/infiltrates | Respiratory, thoracic and mediastinal disorders |
|
| Grade 1 Creatinine increase | Renal and urinary disorders |
|
| Grade 2 Creatinine increase | Renal and urinary disorders |
|
| Grade 1 GU - other | Renal and urinary disorders |
|
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| 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 |
| 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 |
| D007093 | Imidazoles |
| D001393 | Azoles |