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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112827 |
RATIONALE: Drugs used in chemotherapy, such as 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. Radiation therapy uses high-energy x-rays to kill cancer cells. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving chemotherapy together with radiation therapy, thalidomide, and autologous stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given together with high-dose melphalan followed by dexamethasone and thalidomide and to see how well they work in treating patients who are undergoing autologous stem cell transplant for stage I, stage II, or stage III multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Drug: cyclophosphamide Drug: dexamethasone Drug: melphalan Drug: thalidomide Procedure: autologous-autologous tandem hematopoietic stem cell transplantation Radiation: total marrow irradiation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Tandem High-Dose Therapy With Melphalan & Total Marrow Irradiation (TMI) With PBPC Support & Dexamethasone/Thalidomide Maintenance |
Estimated Enrollment: | 86 |
Study Start Date: | October 2004 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of total marrow irradiation (TMI).
Ablative therapy:
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 3-86 patients (3-36 for the phase I portion and 28-50 for the phase II portion) will be accrued for this study within approximately 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 within the past 18 months
Smoldering myeloma allowed provided there is evidence of progressive disease requiring therapy, as indicated by any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 2 weeks since prior bisphosphonates
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org |
Responsible Party: | City of Hope Comprehensive Cancer Center ( George Somlo ) |
Study ID Numbers: | CDR0000428410, CHNMC-04064 |
Study First Received: | June 2, 2005 |
Last Updated: | June 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00112827 History of Changes |
Health Authority: | Unspecified |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Melphalan Thalidomide Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Anti-Bacterial Agents |
Hemorrhagic Disorders Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Angiogenesis Inhibitors Immunosuppressive Agents Glucocorticoids Multiple Myeloma Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Lymphoproliferative Disorders |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Melphalan Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders |
Hormones Anti-Bacterial Agents Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Growth Substances |