Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038090 |
In patients with previously untreated multiple myeloma to assess the activity of the combination of thalidomide and dexamethasone.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Thalidomide and dexamethasone |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 78 |
Study Start Date: | September 2001 |
This study will examine the potential efficacy of thalidomide-dexamethasone in the treatment of patients with previously untreated multiple myeloma.
Thalidomide is supplied as 50 mg capsules to be taken by mouth. Thalidomide 200 mg daily each evening at bedtime increasing by 100-200 mg increments (according to patient tolerability) every 4 weeks. For elderly patients, or those with poor performance status or comorbid conditions which may affect tolerance of the thalidomide-dexamethasone combination, the initial dose may be reduced by 50-100 mg decrements and escalated weekly by 50-100 mg increments to tolerance. For patients who experience significant toxicity (> grade 2) or are otherwise unable to tolerate this drug combination, the dose will be reduced by 50-100 mg decrements. For some patients with > grade 2 toxicity, it may be necessary to hold the thalidomide dose until improvement of the side effect with subsequent resumption of the dose after dose reduction as outlined above. Dexamethasone 20mg/m2 each morning after breakfast on days 1-4, 9-12, 17-20, with a repeat cycle after a 1-2 week rest period. In case of partial remission, maintenance treatment with thalidomide alone will be continued for as long as remission is sustained at a dose free of side effects.
For patients achieving CR, consolidation with thalidomide-dexamethasone for 4-6 months followed by follow-up without maintenance treatment. No maximum trial period is planned. At relapse patients may be reinitiated on the original thalidomide-pulse dexamethasone program and responding patients may be maintained on thalidomide alone (CR) or daily thalidomide and dexamethasone (days 1-4) until relapse.
Patients who experience significant toxicity (grade 2 or more) at any time during therapy will receive a lower dose after treatment is interrupted.
In an attempt to avoid deep venous thrombosis, all patients for whom anticoagulation is not contraindicated will be offered therapeutic anticoagulation (INR 1.5-2.5) with coumadin or therapeutic doses of low molecular weight heparin.
Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | ID00-070 |
Study First Received: | May 28, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00038090 History of Changes |
Health Authority: | United States: Food and Drug Administration |
myeloma, thalidomide |
Dexamethasone Anti-Inflammatory Agents Thalidomide Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders |
Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Angiogenesis Inhibitors Glucocorticoids Immunosuppressive Agents Multiple Myeloma Peripheral Nervous System Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Immunologic Factors Thalidomide Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders |
Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Growth Substances Vascular Diseases Gastrointestinal Agents Angiogenesis Inhibitors Immunosuppressive Agents |