Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CZOL446E | Other Identifier | Novartis |
Not provided
Not provided
Not provided
Poor accrual, changes in management of newly diagnosed myeloma patients, new drugs/more effective regimens.
Not provided
Not provided
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Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
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Investigators planned to accrue 176 participants, to compare the response rate, overall response rate and survival of patients with multiple myeloma (MM) when randomized to two regimens (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone). Investigators also planned to test if treatment with zoledronate immediately prior to chemotherapy results in an enhanced response to treatment (i.e. increase in complete response rates).
Patients Randomized to receive VAD (vincristine, adriamycin, dexamethasone): All patients received four cycles of VAD repeated every 4 weeks. Chemotherapy was administered by continuous IV Infusion for 96 hours: vincristine at a dose of 0.4 mg/day and doxorubicin at a dose of 9 mg/m^2/day. Patients were administered dexamethasone 40 mg by mouth (PO) on days 1 to 4, 9 to 12, and 17 to 20 of the initial two cycles. Dexamethasone was given only on days 1-4 of all subsequent cycles. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle. This schedule continued monthly as long as the patient remained on study. The dose was calculated based on the patients' monthly creatinine clearance. Upon initiation of Zometa therapy, the following guidelines were applied: For patients with creatinine clearance >60 mL/min, the recommended dose remained at 4mg. For patients with reduced creatinine clearance, dosing was calculated to achieve the same area under curve (AUC) as in patients with creatinine clearance of 75 mL/min. Creatinine clearance was calculated using the Cockcroft-Gault formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAD Treatment | Active Comparator | VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle. |
|
| Thalidomide and Dexamethasone Treatment | Active Comparator | Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid | Drug | Patients were randomized to receive zoledronic acid I.V. on either Day 1 or 15 of each cycle. This schedule continued monthly as long as the patient remained on study. The dose was calculated based on the patients' monthly creatinine clearance. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rates of VAD vs. Thalidomide/Dexamethasone | Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of serum monoclonal protein for at least 2 determinations 2 weeks apart. | End of Cycle 4 - 4 Months per Participant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events, by Group | Number of participants with toxicities of Thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed multiple myeloma (MM). | 4 Years, 7 Months |
| Number of Participants With Progression Free Survival (PFS), by Treatment Arm |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Alsina, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States | ||
| Watson Clinic |
90 participants were consented. 83 were eligible and randomized to treatment arms. 2 became ineligible after randomization and prior to treatment. 8 withdrew prior to treatment. 73 began treatment.
Recruitment began at Moffitt Cancer Center in June of 2003 and ended prematurely in December of 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: VAD Treatment | VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| dexamethasone | Drug | As outlined in VAD Treatment arm and Thalidomide and Dexamethasone Treatment arm |
|
|
| thalidomide | Drug | As outlined in Thalidomide and Dexamethasone Treatment arm |
|
|
| vincristine | Drug | As outlined in VAD Treatment Arm |
|
|
| adriamycin | Drug | As outlined in VAD Treatment arm |
|
|
Number of participants with PFS for thalidomide/Dexamethasone vs. VAD with respect to progression free survival in newly diagnosed MM. Progressive Disease (PD): (for patients not in CR) Requires one or more of the following; > 25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. > 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg and confirmed on a repeat investigation. >25% increase in plasma cells in a bone marrow aspirate, which also must be an absolute increase of at least 10%. Definite increase in the size of existing lytic lesions or plasmacytomas. Development of new bone lesions or plasmacytomas (except compression fractures). Development of hypercalcemia (corrected calcium > 11.5 mg/dL not attributable to other causes). |
| 4 Months |
| Overall Survival (OS), by Treatment Arm | Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive. Investigators had planned to accrue 176 participants to calculate median overall survival. | Up to 10 Years |
| Lakeland |
| Florida |
| 33805 |
| United States |
| Fawcett Memorial Hospital | Port Charlotte | Florida | 33949 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| San Juan VA Hospital | San Juan | 00921 | Puerto Rico |
| FG001 | Active Comparator: Thalidomide and Dexamethasone Treatment | Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: VAD Treatment | VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle. |
| BG001 | Active Comparator: Thalidomide and Dexamethasone Treatment | Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||||
| Sex: Female, Male | 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 | Response Rates of VAD vs. Thalidomide/Dexamethasone | Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of serum monoclonal protein for at least 2 determinations 2 weeks apart. | All evaluable participants | Posted | Number | participants | End of Cycle 4 - 4 Months per Participant |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events, by Group | Number of participants with toxicities of Thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed multiple myeloma (MM). | All evaluable participants | Posted | Number | participants | 4 Years, 7 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progression Free Survival (PFS), by Treatment Arm | Number of participants with PFS for thalidomide/Dexamethasone vs. VAD with respect to progression free survival in newly diagnosed MM. Progressive Disease (PD): (for patients not in CR) Requires one or more of the following; > 25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. > 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg and confirmed on a repeat investigation. >25% increase in plasma cells in a bone marrow aspirate, which also must be an absolute increase of at least 10%. Definite increase in the size of existing lytic lesions or plasmacytomas. Development of new bone lesions or plasmacytomas (except compression fractures). Development of hypercalcemia (corrected calcium > 11.5 mg/dL not attributable to other causes). | All evaluable participants | Posted | Number | participants | 4 Months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS), by Treatment Arm | Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive. Investigators had planned to accrue 176 participants to calculate median overall survival. | All participants with evaluable follow-up data. | Posted | Median | Full Range | months | Up to 10 Years |
|
5 years
All participants who received treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator: VAD Treatment | VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle. | 0 | 36 | 36 | 36 | ||
| EG001 | Active Comparator: Thalidomide and Dexamethasone Treatment | Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. | 1 | 37 | 37 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis/pulmonary infiltrates - Grade 4 | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain or cramping | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Bilirubin | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTC V3 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Depressed level of consciousness | General disorders | CTC V3 | Systematic Assessment |
| |
| Diarrhea - patients without colostomy | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Dizziness/lightheadedness | General disorders | CTC V3 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Dysuria (painful urination) | Renal and urinary disorders | CTC V3 | Systematic Assessment |
| |
| Edema | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTC V3 | Systematic Assessment |
| |
| Fever (in the absence of neutropenia) | General disorders | CTC V3 | Systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | CTC V3 | Systematic Assessment |
| |
| Low Hemoglobin | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTC V3 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hypoalbuminemia | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTC V3 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTC V3 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Infection without neutropenia | Infections and infestations | CTC V3 | Systematic Assessment |
| |
| Insomnia | General disorders | CTC V3 | Systematic Assessment |
| |
| Low Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Melena/GI bleeding | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Mood alteration-anxiety, agitation | General disorders | CTC V3 | Systematic Assessment |
| |
| Mouth dryness | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Myalgia (muscle pain) | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Neuropathy - motor | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Neuropathy - sensory | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment |
| |
| Low Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Low Platelets | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment |
| |
| Prothrombin time (PT) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTC V3 | Systematic Assessment |
| |
| Rigors, chills | General disorders | CTC V3 | Systematic Assessment |
| |
| SGOT (AST) (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| SGPT (ALT) (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTC V3 | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | Cardiac disorders | CTC V3 | Systematic Assessment |
| |
| Sweating (diaphoresis) | General disorders | CTC V3 | Systematic Assessment |
| |
| Syncope (fainting) | General disorders | CTC V3 | Systematic Assessment |
| |
| Taste disturbance (dysgeusia) | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTC V3 | Systematic Assessment |
| |
| Transfusion - Platelets | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Transfusion: pRBCs | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment |
| |
| Tremor | General disorders | CTC V3 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC V3 | Systematic Assessment |
| |
| Weight loss | General disorders | CTC V3 | Systematic Assessment |
|
Target accrual for planned analysis (176) was not met. Principal Investigator (PI) determined study must close due to changes in the management of newly diagnosed myeloma (emergence of new drugs, more effective regimens).
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Alsina, M.D. | H. Lee Moffitt Cancer Center and Research Institute | 813-745-6886 | melissa.alsina@moffitt.org |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D019337 | Hematologic Neoplasms |
| 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 |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D013792 | Thalidomide |
| D014750 | Vincristine |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur 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 |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Minimal Response |
|
| Participants |
|
|
| OG001 |
| Active Comparator: Thalidomide and Dexamethasone Treatment |
Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. |
|
|
| Units | Counts |
|---|
| Participants |
|
|