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Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma Clinical research trials and Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma. Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma  Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma
Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma
For Condition: stage 1 multiple myeloma,stage 2 multiple myeloma,stage 3 multiple myeloma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B,Eastern Cooperative Oncology Group,Southwest Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation therapy and kill more cancer cells. It is not yet known which treatment regimen is more effective for multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan, total-body irradiation, and peripheral stem cell transplantation with that of combination chemotherapy in treating patients who have previously untreated multiple myeloma.
Details: OBJECTIVES: I. Compare tumor cytoreduction achieved with VBMCP (vincristine/carmustine/melphalan/cyclophosphamide/prednisone) vs myeloablative melphalan (L-PAM) and total-body irradiation (TBI) with peripheral blood stem cell (PBSC) rescue in symptomatic myeloma patients with stable or responding disease after induction therapy with VAD (vincristine/doxorubicin/dexamethasone) followed by high dose cyclophosphamide plus filgrastim (G-CSF). II. Compare the efficacy of interferon alfa vs no maintenance therapy in those patients achieving at least 75% cytoreduction to either VBMCP or myeloablative therapy with PBSC rescue. III. Assess allogeneic bone marrow transplantation following the same myeloablative regimen of L-PAM/TBI in patients up to age 55 with an HLA-compatible, MLC-nonreactive donor. (As of 8/1/97, permanent partial closure) IV. Determine whether myeloablative therapy with PBSC rescue can extend the duration of survival by 33% compared to results from standard dose VBMCP. V. Evaluate the toxic effects and possible long term side effects, including development of myelodysplastic disease and/or acute myeloblastic leukemia, associated with these treatments. PROTOCOL OUTLINE: This is a randomized study. Patients are registered at 5 different points, with stratification occurring at some of these registrations. Registration I: Induction I Registration II: Induction II. Patients are stratified according to stage of disease (I/II vs IIIA vs IIIB), beta-2 microglobulin at diagnosis (less than 6 micrograms/mL vs at least 6 micrograms/mL), and response to Induction I (75-100% regression vs 50-74% regression vs less than 50% regression vs not applicable). Registration III: Patients are randomized to allogeneic bone marrow transplant (BMT) (this arm closed as of 8/1/97) or autologous BMT. Patients are stratified according to treatment received (high dose cyclophosphamide (CTX) and peripheral blood stem cells (PBSC) prior to autologous BMT vs prior to chemotherapy) and beta-2 microglobulin at this registration (less than 2 micrograms/mL vs no greater than 3 micrograms/mL vs unknown). Registration IV: Patients are randomized to maintenance therapy or no further therapy. Those patients who are randomized to maintenance therapy are stratified according to treatment (autologous BMT vs chemotherapy vs chemotherapy followed by autologous BMT) and response to treatment (75-99% regression vs complete response). Registration V: Patients receive autologous BMT as in registration III. Patients are stratified according to prior best response (50% or better vs less than 50% vs not applicable), duration of chemotherapy (at least 6 months vs less than 6 months), and progression after therapy (chemotherapy vs interferon alfa vs observation). Induction I: Patients receive vincristine IV and doxorubicin IV by continuous infusion on days 1-4 and dexamethasone IV or orally on days 1-4, 9-12, and 17-20. Treatment repeats every 5 weeks for up to 4 courses. Patients with progressive disease after 2 courses proceed to PBSC stimulation/harvest. Allogeneic BMT arm is permanently closed as of 8/1/97. Autologous BMT: Therapy begins 4-8 weeks following high dose cyclophosphamide. Patients receive melphalan IV over 1 hour on day -5 and total body irradiation twice a day on days -4 to -1. PBSC are reinfused on day 0. G-CSF SQ is administered beginning on day 1 until blood counts recover. Chemotherapy: Patients receive vincristine IV, carmustine IV, and cyclophosphamide IV on day 1, oral melphalan on days 1-4, and oral prednisone on days 1-7. Treatment repeats every 5 weeks for at least 12 months. Patients who have at least a 75% response to autologous BMT or chemotherapy are randomized to maintenance vs no further therapy. Patients who progress on chemotherapy proceed to autologous BMT (registration V). Maintenance therapy: Therapy begins between 5 and 12 weeks after PBSC rescue. Patients receive interferon alfa SQ three times a week. Treatment continues for 4 years in the absence of disease progression or unacceptable toxicity. Patients who progress on chemotherapy undergo an autologous BMT within 8 weeks after the last course of chemotherapy. Patients who are randomized to receive no further therapy are observed for 1 year. PROJECTED ACCRUAL: A total of 500 patients will be randomized over about 4 years to autologous transplantation vs chemotherapy as follows: about 250 patients/year will be accrued for induction of whom 200 will achieve at least stable disease, 125 will be randomized, and 15 will have a suitable donor for allogeneic transplant (as of 8/1/97, allogeneic arm of study is closed). Approximately 300 patients are expected to be randomized to maintenance vs no further therapy.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Newly diagnosed, active multiple myeloma of any stage requiring treatment - Smoldering myeloma (Durie-Salmon stage I) must have a 25% or greater increase in M component levels and/or Bence-Jones protein excretion or development of symptoms Quantifiable M component of IgG, IgA, IgD, IgE, and/or urinary kappa or lambda light chain (Bence-Jones protein) excretion required - Plasmacytosis of at least 30% allowed for non-secretory disease or secretory disease without quantifiable protein - IgM peaks excluded Evaluation of siblings as potential allogeneic bone marrow transplant donors required for patients 55 years of age and younger (As of 8/1/97, permanently closed) - HLA followed by DR and MLC testing required Renal failure, even on dialysis, eligible provided: - Cause is attributed to myeloma (Bence-Jones protein or hypercalcemia) - Duration does not exceed 2 months If medically appropriate, the following conditions should be treated prior to registration: - Pathologic fractures - Pneumonia at diagnosis - Hyperviscosity with shortness of breath --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy except local radiotherapy provided the following cumulative dose limits for prior dose plus potential TBI dose on protocol are not exceeded: - Less than 5,000 cGy to bone - Less than 4,000 cGy to mediastinum, heart, small bowel, brain, and spinal cord - Less than 2,000 cGy to the liver - Less than 1,500 cGy to the kidney and lungs Surgery: Not specified --Patient Characteristics-- Age: 70 and under Performance status: SWOG 0-2 (SWOG 3 or 4 based solely on bone pain allowed) Hematopoietic: Not specified Hepatic: Not specified Renal: See Disease Characteristics Cardiovascular: - Normal ejection fraction by ECHO or MUGA - No myocardial infarction within 6 months - No unstable angina - No difficult to control congestive heart failure - No uncontrolled hypertension - No difficult to control arrhythmias - No history of chronic cerebral vascular accident Pulmonary: - No history of chronic obstructive or restrictive pulmonary disease - Pulmonary function studies and DLCO at least 50% of predicted except for demonstrated myeloma involvement on bronchoscopy and/or open lung biopsy Other: - No uncontrolled diabetes - No significant comorbid medical condition - No uncontrolled, life-threatening infection - No prior malignancy within 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No prior malignancy treated with cytotoxic drugs used on this protocol - Not pregnant or nursing - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesColtman, Study Chair, Southwest Oncology Group
Veterans Affairs Medical Center - New York
New York City, New York, 10010
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Additional Information:
Study ID Numbers: CDR0000063310; SWOG-9321,INT-0141
Study Start Date: March 1994
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002548
Other Stage 1 Multiple Myeloma Studies:
1. Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma
2. Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
3. Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With 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. Beta Alethine in Treating Patients With Myeloma
Related Studies:
Other stage 1 multiple myeloma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma
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