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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Cancer and Leukemia Group B Eastern Cooperative Oncology Group |
| Information provided by: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002548 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: recombinant interferon alfa Drug: carmustine Drug: cyclophosphamide Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: melphalan Drug: prednisone Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | STANDARD DOSE VERSUS MYELOABLATIVE THERAPY FOR PREVIOUSLY UNTREATED SYMPTOMATIC MULTIPLE MYELOMA, A PHASE III INTERGROUP STUDY |
| Estimated Enrollment: | 500 |
| Study Start Date: | January 1994 |
3 million units/m2 SQ Monday-Wednesday
-Friday (3 times a week)
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed, active multiple myeloma of any stage requiring treatment
Quantifiable M component of IgG, IgA, IgD, IgE, and/or urinary kappa or lambda light chain (Bence-Jones protein) excretion required
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)
Renal failure, even on dialysis, eligible provided:
If medically appropriate, the following conditions should be treated prior to registration:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
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:
Surgery:
Contacts and Locations
Show 34 Study Locations| Study Chair: | Bart Barlogie, MD | University of Arkansas |
| Study Chair: | Kenneth C. Anderson, MD | Dana-Farber Cancer Institute |
| Study Chair: | Robert A. Kyle, MD | Mayo Clinic |
More Information
| Responsible Party: | Laurence H. Baker, D.O/Chair, Southwest Oncology Group, Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002548 History of Changes |
| Other Study ID Numbers: | CDR0000063310, SWOG-9321, CLB-9312, E-S9321, INT-0141, U10CA032102 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Federal Government |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Interferon-alpha Interferon Alfa-2a Interferons Cyclophosphamide Melphalan Carmustine Dexamethasone Doxorubicin Prednisone Vincristine Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Antiviral Agents Anti-Infective Agents |