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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 |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Multiple Myeloma |
| ChemIDplus related topics: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Thalidomide Lenalidomide CC 5013 Acetylsalicylic acid |
| 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.
In both arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 courses of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms. Patients who progress during treatment on arms I or II have the option to register on salvage therapy arms III or IV respectively.
In both salvage therapy arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of 4 courses of therapy, patients may undergo stem cell harvest (using growth factors only) for cryopreservation.
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 |
| Eastern Cooperative Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | S. V. Rajkumar, MD | Mayo Clinic |
| Investigator: | Rafael Fonseca, MD | Mayo Clinic Scottsdale |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Rajkumar SV, Jacobus S, Callander N, et al.: A randomized phase III trial of lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone in newly diagnosed multiple myeloma (E4A03): a trial coordinated by the Eastern Cooperative Oncology Group. [Abstract] Blood 108 (11): A-799, 2006. |
| Study ID Numbers: | CDR0000404161, ECOG-E4A03 |
| First Received: | December 7, 2004 |
| Last Updated: | July 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00098475 |
| Health Authority: | United States: Food and Drug Administration |
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