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| Sponsored by: |
Riverside Haematology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003603 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more effective in treating patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: cyclophosphamide Drug: dexamethasone Drug: idarubicin Drug: lomustine Drug: melphalan Drug: prednisolone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma |
| Estimated Enrollment: | 660 |
| Study Start Date: | March 1998 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to prior autologous transplant (yes vs no). Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline, at 3, 6, 9, and 12 months, and then every 6 months thereafter.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma based on at least two of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000066676, RHG-MM97, EU-98030 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003603 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
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Anti-Inflammatory Agents Dexamethasone Melphalan Immunologic Factors Blood Protein Disorders Methylprednisolone Hormone Antagonists Lomustine Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Prednisolone acetate Cyclophosphamide Hemostatic Disorders Neuroprotective Agents |
Hormones Anti-Bacterial Agents Hemorrhagic Disorders Alkylating Agents Dexamethasone acetate Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Methylprednisolone acetate Glucocorticoids Immunosuppressive Agents Multiple Myeloma |
|
Anti-Inflammatory Agents Dexamethasone Melphalan Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Prednisolone acetate Cyclophosphamide Antibiotics, Antineoplastic |
Hemostatic Disorders Neuroprotective Agents Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Dexamethasone acetate Methylprednisolone Hemisuccinate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Gastrointestinal Agents |