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| Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00293306 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, melphalan, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving chemotherapy with a stem cell transplant, using stem cells from the patient, may allow more chemotherapy to be given so more cancer cells are killed. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving maintenance therapy, using dexamethasone and thalidomide, after an autologous stem cell transplant may kill any cancer cells that remain.
PURPOSE: This clinical trial is studying how well giving cyclophosphamide and melphalan followed by an autologous stem cell transplant together with dexamethasone and thalidomide works in treating patients with previously treated multiple myeloma.
| Condition | Intervention |
|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: cyclophosphamide Drug: dexamethasone Drug: filgrastim Drug: melphalan Drug: thalidomide Procedure: peripheral blood stem cell transplantation |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Autologous Transplantation for Multiple Myeloma |
| Estimated Enrollment: | 70 |
| Study Start Date: | April 2004 |
OBJECTIVES:
OUTLINE: Patients receive high-dose cyclophosphamide IV over 2 hours. Patients then receive filgrastim (G-CSF) and undergo stem cell collection. Patients with an insufficient number of stem cells are removed from study. Beginning 2-4 weeks later, patients deemed suitable by the principal investigator receive high-dose melphalan IV on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation on day 0. Patients receive G-CSF beginning on day 5 and continuing until blood counts recover. Patients may receive radiotherapy. After blood counts recovery, patients receive maintenance therapy comprising dexamethasone and thalidomide. Treatment with dexamethasone and thalidomide may continue for up to 1 year in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| University of Minnesota Children's Hospital - Fairview | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - University of Minnesota Children's Ho 612-273-3000 | |
| Study Chair: | Mukta Arora, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Study ID Numbers: | CDR0000450771, UMN-2004LS001, UMN-MT2003-13, UMN-0312M54569 |
| Study First Received: | February 16, 2006 |
| Last Updated: | November 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00293306 |
| Health Authority: | Unspecified |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
|
Dexamethasone Melphalan Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Cyclophosphamide Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
|
Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Anti-Bacterial Agents Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents |
Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Angiogenesis Inhibitors Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents |
