![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014508 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's tissues. Peripheral stem cell transplantation with the person's own stem cells followed by donor peripheral stem cell transplantation may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with autologous peripheral stem cell transplantation and donor peripheral stem cell transplantation in treating patients who have multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: sargramostim Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: melphalan Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial Of Autologous Stem Cell Transplant Followed By Mini-Allogeneic Stem Cell Transplant In Lieu Of Standard Allogeneic Bone Marrow Transplantation For Treatment Of Multiple Myeloma |
Study Start Date: | April 2001 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive melphalan IV over 15 minutes on day -1. Autologous peripheral blood stem cells (PBSCs) are reinfused on day 0. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) or IV over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover. Beginning 100-182 days after autologous PBSC transplantation, patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -3 and -2. Allogeneic PBSCs are infused on day 0. Patients may receive a second allogeneic PBSC infusion on day 1. Patients also receive GM-CSF SC or IV over at least 30 minutes daily beginning on day 1 and continuing until blood counts recover. Cyclosporine is administered IV or orally twice daily as graft-versus-host disease (GVHD) prophylaxis, beginning on day -1 and continuing until day 60, followed by a taper in the absence of GVHD.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total 19-46 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma meeting 1 of the following criteria:
Meets at least 1 of the following criteria:
Radiographic evidence of osteolytic lesions
No non-secretory myeloma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Florida | |
Baptist Cancer Institute - Jacksonville | |
Jacksonville, Florida, United States, 32207-8554 | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Cancer Center at Tufts - New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 | |
CCOP - Northern New Jersey | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
MBCCOP-Our Lady of Mercy Cancer Center | |
Bronx, New York, United States, 10466 | |
United States, Ohio | |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
Cleveland, Ohio, United States, 44106-5065 | |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109 | |
United States, Pennsylvania | |
Abramson Cancer Center at the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033-0850 |
Study Chair: | Neal Flomenberg, MD | Kimmel Cancer Center (KCC) |
Study ID Numbers: | CDR0000068551, ECOG-E4A98 |
Study First Received: | April 10, 2001 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00014508 History of Changes |
Health Authority: | United States: Federal Government |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Antimetabolites Melphalan Anti-Infective Agents Cyclosporine Immunologic Factors Blood Protein Disorders Paraproteinemias Cyclophosphamide Hemostatic Disorders Cyclosporins Hemorrhagic Disorders Antifungal Agents Alkylating Agents |
Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Fludarabine monophosphate Immunosuppressive Agents Multiple Myeloma Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antirheumatic Agents Neoplasms, Plasma Cell |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Cyclophosphamide Hemostatic Disorders Cyclosporins Hemorrhagic Disorders Antifungal Agents |
Therapeutic Uses Cardiovascular Diseases Dermatologic Agents Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Vascular Diseases Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms |