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| Sponsored by: |
Medical College of Wisconsin |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003163 |
Purpose
RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have multiple myeloma or other B-cell cancers.
| Condition | Intervention | Phase |
|
Lymphoma Multiple Myeloma and Plasma Cell Neoplasm |
Drug: cyclophosphamide Drug: filgrastim Drug: melphalan Drug: sargramostim Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Bone Marrow Transplantation Cancer Lymphoma Multiple Myeloma |
| ChemIDplus related topics: | Cyclophosphamide Filgrastim Melphalan Sargramostim Granulocyte-macrophage colony-stimulating factor Melphalan hydrochloride Sarcolysin |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies |
| Estimated Enrollment: | 10 |
| Study Start Date: | September 1997 |
OBJECTIVES:
OUTLINE: Patients must have hematopoietic stem cell procurement completed prior to myeloablative therapy. Patients receive high dose chemotherapy with autologous hematopoietic stem cell transplantation and supportive care. Melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Peripheral blood stem cells and/or bone marrow is reinfused on day 0. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered beginning on day 1 posttransplantation and continuing until blood counts recover.
Patients who are not candidates for tandem transplant may receive melphalan plus total body irradiation (TBI). Melphalan is administered IV on day -4. Total body irradiation is administered three times a day on days -3 and -2 and twice on day -1. At least 4 hours must elapse between each treatment. Hematopoietic stem cells are reinfused on day -1 upon completion of TBI or on day 0.
If patient is ineligible for melphalan plus TBI, the alternative single high dose regimen of melphalan plus cyclophosphamide is administered. Melphalan, for these patients, is given in two equal doses on day -4 followed by two consecutive days of cyclophosphamide on days -3 and -2. Hematopoietic stem cells are reinfused on day 0.
A second transplant may be considered, preferably between 3 and 6 months after the first transplant. The preferred regimen for the second transplant is melphalan alone or melphalan plus TBI as described above. The alternative regimens for the second dose therapy are melphalan alone or melphalan plus cyclophosphamide. For patients receiving melphalan alone, melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Hematopoietic stem cells are reinfused on day 0 for both alternative regimens.
Patients are followed for response from treatment for a minimum of 4 weeks and then periodically for survival.
PROJECTED ACCRUAL: A minimum of 10 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed multiple myeloma or other B-cell malignancy including non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, or amyloidosis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Wisconsin | |||||
| Medical College of Wisconsin | |||||
| Milwaukee, Wisconsin, United States, 53226 | |||||
| Medical College of Wisconsin |
| Study Chair: | David H. Vesole, MD, PhD | Medical College of Wisconsin |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000065959, MCW-96110, MCW-HRRC-29196, NCI-V97-1368 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003163 |
| Health Authority: | United States: Federal Government |
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