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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098475 |
Purpose
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.
PURPOSE: This randomized phase III trial is studying lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: acetylsalicylic acid Drug: dexamethasone Drug: lenalidomide Drug: thalidomide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders |
| Estimated Enrollment: | 412 |
| Study Start Date: | October 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 412 patients (206 per treatment arm) will be accrued for this study within 24 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma within the past 90 days, confirmed by the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No other active malignancy
No active uncontrolled seizure disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
The following treatments for non-malignant disorders are allowed:
Radiotherapy
Surgery
Other
Contacts and Locations
Show 243 Study Locations| Study Chair: | S. V. Rajkumar, MD | Mayo Clinic |
| Investigator: | Rafael Fonseca, MD | Mayo Clinic Scottsdale |
More Information
| Study ID Numbers: | CDR0000404161, ECOG-E4A03 |
| Study First Received: | December 7, 2004 |
| Last Updated: | January 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00098475 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Dexamethasone Anti-Inflammatory Agents Immunologic Factors Thalidomide Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Fibrinolytic Agents Hemostatic Disorders Hormones Anti-Bacterial Agents Fibrin Modulating Agents Hemorrhagic Disorders |
Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Cyclooxygenase Inhibitors Vascular Diseases Lenalidomide Cardiovascular Agents Angiogenesis Inhibitors Immunosuppressive Agents Glucocorticoids |
|
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Fibrin Modulating Agents Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Immunoproliferative Disorders |
Immune System Diseases Antineoplastic Agents, Hormonal Hematologic Diseases Cyclooxygenase Inhibitors Glucocorticoids Multiple Myeloma Neoplasms Platelet Aggregation Inhibitors Leprostatic Agents Thalidomide Immunologic Factors Blood Protein Disorders Antineoplastic Agents Paraproteinemias Fibrinolytic Agents |