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Study 14 of 872 for search of: | "Paraproteinemias" |
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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00028600 |
RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine phosphate Drug: melphalan Drug: methotrexate Drug: tacrolimus Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma |
Estimated Enrollment: | 63 |
Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until peripheral blood stem cell (PBSC) collection is complete.
Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 15-30 minutes on day -2. Patients then undergo autologous PBSC transplantation (PBSCT) on day 0. Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover.
Approximately 2-4 months after autologous PBSCT, patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 hour on days -4 to -3. Patients undergo allogeneic PBSCT on day 0. Patients receive G-CSF SC beginning on day 7 and continuing until blood counts recover.
Patients receive graft-vs-host disease (GVHD) prophylaxis comprising oral tacrolimus twice daily on days -1 to 90 followed by a taper on days 91-150 and methotrexate IV on days 1, 3, and 6.
After day 120, patients with stable or progressive disease and no evidence of active GVHD may receive donor lymphocyte infusion (DLI) over 2 hours. Patients may receive up to 3 DLIs every 8 weeks.
Patients are followed every 3 months for 3 years, every 6 months for 5 years, and then annually for 15 years.
PROJECTED ACCRUAL: A maximum of 63 patients will be accrued for this study.
Ages Eligible for Study: | up to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of active multiple myeloma that requires treatment
Must have HLA-identical sibling donor (6/6) by serologic typing (A, B, DR)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Delaware | |
CCOP - Christiana Care Health Services | |
Newark, Delaware, United States, 19713 | |
Tunnell Cancer Center at Beebe Medical Center | |
Lewes, Delaware, United States, 19958 | |
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242-1002 | |
United States, Maryland | |
Union Hospital Cancer Program at Union Hospital | |
Elkton MD, Maryland, United States, 21921 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis | |
St Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Cancer Institute of New Jersey at Cooper - Voorhees | |
Voorhees, New Jersey, United States, 08043 | |
United States, New York | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210-1240 | |
United States, Pennsylvania | |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |
Pittsburgh, Pennsylvania, United States, 15224-1791 |
Study Chair: | Kenneth C. Anderson, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000069109, CALGB-100001 |
Study First Received: | January 4, 2002 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00028600 |
Health Authority: | United States: Federal Government |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Melphalan Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Tacrolimus Fludarabine monophosphate Cyclophosphamide |
Hemostatic Disorders Multiple Myeloma Folic Acid Hemorrhagic Disorders Multiple myeloma Methotrexate Fludarabine Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Abortifacient Agents Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |