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Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma Clinical research trials and Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma. Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma clinical trial. Participants frequently obtain the most expert healthcare available for their Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma  Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma
Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma
For Condition: stage 1 multiple myeloma,stage 3 multiple myeloma,stage 2 multiple myeloma
Status: Recruiting
Sponsor(s): Beckman Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide in treating patients who have stage I, stage II, or stage III multiple myeloma.
Details: OBJECTIVES: - Determine the feasibility and toxic effects of high-dose melphalan, busulfan, and cyclophosphamide followed by autologous peripheral blood stem cell rescue, interferon alfa, and pamidronate in patients with responsive or stable, low-bulk multiple myeloma. - Determine the response rate and progression-free and overall survival of patients treated with this regimen. - Determine the feasibility of adding thalidomide to interferon alfa and pamidronate in patients who are not in complete remission (CR) 6 months after the second course of high-dose chemotherapy. - Determine whether administration of thalidomide can increase the CR rate in patients who are not in CR 6 months after the second course of high-dose chemotherapy and determine its effect on progression-free and overall survival of these patients. - Determine the pharmacokinetics of busulfan and cyclophosphamide and correlate the pharmacokinetics with the toxic effects of these drugs and outcome in these patients. - Determine the effect of thalidomide on microvascular density of bone marrow and correlate these possible effects with outcome in these patients. - Determine the cytogenetics, gene rearrangement, and fluorescence in situ hybridization in baseline and post treatment bone marrow and blood specimens and correlate the presence/persistence of these features with treatment outcome in these patients. OUTLINE: Patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) or IV twice a day beginning on day 2 and continuing until peripheral blood stem cells (PBSCs) are collected. PBSCs are collected beginning on day 10. Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover. Patients with responding or stable disease after chemotherapy receive maintenance therapy with interferon alfa beginning 14-20 weeks after day 0 of the second course of chemotherapy. Interferon alfa is administered SC 3 times a week for 3 years. Patients also receive pamidronate IV every 4 weeks until disease progression. Patients who are not in complete remission (CR) 6 months after completing the second course of chemotherapy receive oral thalidomide daily for a maximum of 1 year or for 3 months after achieving CR. Patients are followed monthly for 1 year, every 3 months for 1 year, and then periodically thereafter. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within approximately 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven stage I-III multiple myeloma - Less than 18 months since diagnosis - Smoldering myeloma allowed if there is evidence of progressive disease requiring therapy - At least 25% increase in M protein levels or Bence Jones excretion - Hemoglobin no greater than 10.5 g/dL - Hypercalcemia - Frequent infections - Rise in serum creatinine above normal on 2 separate occasions - Nonquantifiable monoclonal proteins allowed if other criteria for multiple myeloma or smoldering myeloma are met - Response/status after induction therapy: - Responding or stable disease AND no greater than 40% myelomatous involvement of bone marrow - No Waldenstrom's macroglobulinemia PATIENT CHARACTERISTICS: Age: - 65 and under Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT and SGPT less than 2.5 times upper limit of normal - Hepatitis B antigen or hepatitis C RNA negative Renal: - See Disease Characteristics - Creatinine no greater than 1.4 mg/dL - Creatinine clearance greater than 65 mL/min Cardiovascular: - Cardiac ejection fraction at least 50% by MUGA or echocardiogram Pulmonary: - FEV_1 greater than 60% - DLCO greater than 50% of predicted lower limit Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No other medical or psychosocial problems that would increase patient risk - No other malignancy within past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix - No known hypersensitivity to filgrastim (G-CSF) or E. coli-derived proteins PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No more than 3 prior chemotherapy regimens - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeSomlo, Study Chair, Beckman Research Institute
Good Samaritan Regional Medical Center *Recruiting*
Phoenix, Arizona, 85006
United States
Recruiting Jeffrey Schriber 602-239-4526
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting George Somlo 626-359-8111
Additional Information:
Study ID Numbers: CDR0000067301; CHNMC-IRB-99021,NCI-G99-1583
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004088
Other Stage 2 Multiple Myeloma Studies:
1. R115777 in Treating Patients With Relapsed or Refractory Multiple Myeloma
2. Bevacizumab With or Without Thalidomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon alfa in Treating Patients With Advanced Multiple Myeloma
4. Total-Body Irradiation, Busulfan, and Interferon alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma
5. Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma
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