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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008242 |
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of thalidomide, doxorubicin, and dexamethasone in treating patients who have untreated stage II or stage III multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Clinical Trial Of Thalidomide, Adramycin And Dexamethasone (TAD) As Initial Therapy For The Treatment Of Multiple Myeloma |
Study Start Date: | August 2000 |
OBJECTIVES: I. Determine the response rate of patients with previously untreated stage II or III multiple myeloma treated with thalidomide, doxorubicin, and dexamethasone. II. Determine the safety and toxicity of this regimen in this patient population.
OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20, doxorubicin IV on day 1, and oral thalidomide daily. Treatment repeats every 30 days for 4 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within approximately 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Stage II disease Symptomatic due to progressive disease OR Stage III disease No stage I multiple myeloma or smoldering myeloma
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: More than 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3* Platelet count at least 100,000/mm3* *Unless due to multiple myeloma Hepatic: Bilirubin no greater than 2.0 mg/dL ALT and AST no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal: Elevated creatinine allowed Cardiovascular: LVEF at least 50% by MUGA or ECHO No active angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 4 weeks prior to, during, and for at least 4 weeks after study No grade II or greater pre-existing neuropathy No other concurrent or prior active malignancy within the past 2 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix Prior T1a or T1b prostate cancer (detected incidentally at transurethral resection of prostate (TURP) and comprising less than 5% of resected tissue) allowed if PSA normal since TURP HIV negative No AIDS-related illness No other medical condition that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for multiple myeloma Endocrine therapy: No more than 1 course of prior pulse dexamethasone Prior steroids of less than 1 month duration for emergent indications or life-threatening lesions (e.g., hypercalcemia or spinal cord compromise) allowed Radiotherapy: Prior radiotherapy allowed Surgery: Not specified
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Raymond L. Comenzo, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000068390, MSKCC-00077, NCI-G00-1893 |
Study First Received: | January 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00008242 |
Health Authority: | United States: Federal Government |
stage II multiple myeloma stage III multiple myeloma |
Dexamethasone Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Doxorubicin Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Hormones Anti-Bacterial Agents Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents |
Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Glucocorticoids Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Leprostatic Agents |