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Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma



Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma

For Condition: stage 1 multiple myeloma,stage 2 multiple myeloma,stage 3 multiple myeloma
Status: Recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and thalidomide in treating patients who have newly diagnosed stage I, stage II, or stage III multiple myeloma.
Details: OBJECTIVES: - Determine the overall response rate in patients with newly diagnosed stage I, II, or III multiple myeloma treated with vincristine, doxorubicin, dexamethasone, and low-dose thalidomide. - Determine the ability to collect peripheral blood stem cells in patients after treatment with this regimen. OUTLINE: This is an open-label, nonrandomized study. Patients receive vincristine IV and doxorubicin IV continuously on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-21. Patients also receive low-dose oral thalidomide daily on days 1-28. Treatment repeats every 4 weeks for 4-6 courses in the absence of disease progression. Patients are followed until disease progression or bone marrow transplantation. PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Newly diagnosed stage I, II, or III multiple myeloma (MM) - No refractory or relapsed MM PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin less than 1.5 mg/dL - AST less than 2.5 times upper limit of normal Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 effective methods of contraception (including at least 1 highly active method) for at least 4 weeks before, during, and for at least 4 weeks after study - No active serious infections uncontrolled by antibiotics - No insufficient mental capacity that would preclude informed consent - No other medical condition or reason that would preclude study participation - Willing and able to comply with the FDA-mandated S.T.E.P.S program PRIOR CONCURRENT THERAPY: Biologic therapy - No prior thalidomide Chemotherapy - No more than 1 course of prior vincristine, doxorubicin, and dexamethasone Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No concurrent alcohol consumption
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AsherChanan-Khan,  Study Chair,  Roswell Park Cancer Institute

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Asher  Chanan-Khan 716-845-1348


Additional Information:
Study ID Numbers:
  CDR0000269903;  RPCI-RP-0215
Study Start Date: 
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054158

Other Stage 1 Multiple Myeloma Studies:
1. Chemotherapy, Vaccine Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Multiple Myeloma

2. O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

3. Chemotherapy and Peripheral Stem Cell Transplantation Followed By Immunotherapy in Treating Patients With Multiple Myeloma

4. Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma

5. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Refractory Multiple Myeloma

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Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma

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