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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068156 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20032 | |||
| ISRCTN65684689 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma.
PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients without a maximal response after completion of course 4 may receive up to 2 additional courses.
Quality of life is assessed at baseline and then prior to each study course.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| idarubicin | Drug | |||
| vincristine sulfate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of response rates |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve a maximal response | ||
| Duration of response |
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DISEASE CHARACTERISTICS:
Diagnosis of stage II or III multiple myeloma
No indolent multiple myeloma
No monoclonal gammopathy of unknown significance
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Cook, MD, PhD | Leeds Cancer Centre at St. James's University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Heartlands Hospital | Birmingham | England | B9 5SS | United Kingdom | ||
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust |
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| Cambridge |
| England |
| CB2 2QQ |
| United Kingdom |
| Royal Liverpool and Broadgreen Hospitals NHS Trust | Liverpool | England | L7 8XP | United Kingdom |
| New Cross Hospital | Wolverhampton | England | WV10 0QP | United Kingdom |
| Centre for Cancer Research and Cell Biology at Belfast City Hospital | Belfast | Northern Ireland | BT9 7AB | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Vale Of Leven D G Hospital | Alexandria | Scotland | G83 0UA | United Kingdom |
| Dumfries Royal Infirmary | Dumfries | Scotland | DG1 4AP | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | Scotland | DD1 9SY | United Kingdom |
| West of Scotland Cancer Centre | Glasgow | Scotland | G11 6NT | United Kingdom |
| Royal Infirmary - Castle | Glasgow | Scotland | G4 0SF | United Kingdom |
| Royal Alexandra Hospital | Paisley | Scotland | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D004317 | Doxorubicin |
| D015255 | Idarubicin |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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