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Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma Clinical research trials and Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma. Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma clinical trial. Participants oftentimes recieve the finest healthcare available for their Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), 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 and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma  Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma
Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma
For Condition: stage 1 multiple myeloma,stage 2 multiple myeloma,stage 3 multiple myeloma
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether a more intensive chemotherapy regimen plus stem cell or bone marrow transplant is more effective than standard chemotherapy in treating patients with myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy plus interferon alfa with or without high dose melphalan or bone marrow or peripheral stem cell transplantation in treating patients with previously untreated myeloma.
Details: OBJECTIVES: I. Compare survival of patients under age 65 with myeloma treated with standard ABCM (doxorubicin, carmustine, cyclophosphamide, melphalan) vs. intensive C-VAMP (cyclophosphamide, vincristine, doxorubicin, methylprednisolone) followed by high-dose melphalan (with or without total-body irradiation) with bone marrow and peripheral blood stem cell support, both with IFN-A maintenance. II. Compare the toxicity profiles of the 2 treatment arms. III. Compare the 2 treatment arms with respect to quality of life and health economics issues. IV. Investigate cellular changes by means of linked morphology, phenotype, and cytogenetics studies before and after treatment and at relapse. PROTOCOL OUTLINE: Randomized study. The following acronyms are used: ABM Autologous Bone Marrow BCNU Carmustine, NSC-409962 CTX Cyclophosphamide, NSC-26271 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony Stimulating Factor (Amgen), NSC-614629 GM-CSF Granulocyte-Macrophage Colony Stimulating Factor (source not specified) IFN-A Interferon alpha (Hoffmann-La Roche), NSC-367982 L-PAM Melphalan, NSC-8806 MePRDL Methylprednisolone, NSC-19987 PBSC Peripheral Blood Stem Cells PRED Prednisone, NSC-10023 TBI Total-Body Irradiation VCR Vincristine, NSC-67574 ARM I. Induction: 4-Drug Combination Chemotherapy or, as indicated, 2-Drug Combination Chemotherapy. ABCM: DOX; BCNU; CTX; L-PAM; or, if pretreatment ANC and platelets are less than 1,300 and 75,000, CTX; PRED. Maintenance: Biological Response Modifier Therapy. IFN-A. ARM II. Induction: 4-Drug Combination Chemotherapy followed by Hematopoietic Stimulation. C-VAMP: DOX; VCR; MePRDL; CTX; followed by CTX; G-CSF or GM-CSF. Consolidation: 3-Drug Combination Chemoablation with or without Radioablation followed by Hematopoietic Rescue. CTX; L-PAM; MePRDL; with or without TBI using megavoltage equipment (linear accelerator preferred); followed by ABM and/or PBSC. Maintenance: Biological Response Modifier Therapy. IFN-A. PROJECTED ACCRUAL: 750 patients will be accrued.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Definite myeloma requiring chemotherapy and fulfilling at least 2 of the following criteria: Neoplastic plasma cell infiltrate and/or microplasmacytomas on bone marrow aspiration and/or trephine - Paraprotein in blood and/or urine - Definite lytic bone lesions (not simply osteoporosis) - No equivocal myeloma (such patients should be registered with the Clinical Trial Service Unit, Oxford) --Prior/Concurrent Therapy-- - No prior therapy other than minimal local radiotherapy for relief of bone pain --Patient Characteristics-- - Age: Under 65 - Performance status: Not specified - Hematopoietic: (following rehydration and treatment for infection, if necessary); ANC at least 1,000 Platelets at least 50,000 - Hepatic: Not specified - Renal: Renal insufficiency does not necessarily exclude (dose reduction may be applicable) - Cardiovascular: No severe cardiac disease; Past history of ischemic heart disease may exclude at the discretion of the investigator - Pulmonary: No severe respiratory illness - Other: Ability to tolerate at least 3 liters/day of fluid; No life-threatening disease unrelated to myeloma; Prior or concurrent psychiatric disorder may exclude at the discretion of the investigator; No prior malignancy except: Nonmelanomatous skin tumors In situ carcinomas
Total Enrollment:
Location and Contact Information:
Overall Study Official:
J.A.Child, Study Chair, Medical Research Council
Leeds Teaching Hospital Trust
Leeds, England, LS1 3EX
United Kingdom
Additional Information:
Study ID Numbers: CDR0000063834; MRC-LEUK-MYEL-VII,EU-94030
Study Start Date: September 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002599
Other Stage 3 Multiple Myeloma Studies:
1. Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma
2. Dexamethasone With or Without Oblimersen in Treating Patients With Relapsed or Refractory Multiple Myeloma
3. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
4. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
5. Stem Cell Transplantation in Treating Patients With Previously-Treated Multiple Myeloma
Related Studies:
Other stage 3 multiple myeloma Clinical Trials
Other England Clinical Trials
Other Leeds Clinical Trials
Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma
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