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Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma Clinical research trials and Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma. Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma clinical trial. Human subjects often get the best healthcare available for their Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma  Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma
Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma
For Condition: stage 2 multiple myeloma,stage 3 multiple myeloma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RaymondComenzo, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068390; MSKCC-00077,NCI-G00-1893
Study Start Date: August 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008242
Other Stage 3 Multiple Myeloma Studies:
1. R115777 in Treating Patients With Relapsed or Refractory Multiple Myeloma
2. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
3. Interferon alfa Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Multiple Myeloma
4. High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
5. Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma
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