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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00064337 |
Purpose
RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving melphalan together with autologous stem cell transplantation works in treating patients with multiple myeloma or primary systemic amyloidosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Drug: cyclophosphamide Drug: dexamethasone Drug: melphalan Drug: thalidomide Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study) |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2004 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease (high-risk multiple myeloma vs primary systemic amyloidosis vs both).
Mobilization and stem cell collection:
All patients undergo leukapheresis for the collection of stem cells until the target number of CD34+ cells is reached.
Patients undergo a second autologous PBSC transplantation within 3-6 months, but no later than 12 months, after the first transplantation.
Patients are followed at 3 and 6 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 20-25 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 of the following diagnoses:
Multiple myeloma
At least 1 of the following must be present:
Histologically confirmed primary systemic amyloidosis
No severe cardiac involvement
Light Chain Deposition Disease alone or in combination with multiple myeloma meeting the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni 501-686-8274 | |
| United States, California | |
| Alta Bates Summit Comprehensive Cancer Center | Recruiting |
| Berkeley, California, United States, 94704 | |
| Contact: Clinical Trials Office - Alta Bates Summit Comprehensive Cance 510-204-3428 | |
| California Pacific Medical Center - California Campus | Recruiting |
| San Francisco, California, United States, 94118 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| Marin Cancer Institute at Marin General Hospital | Recruiting |
| Greenbrae, California, United States, 94904 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| Sutter Solano Medical Center | Recruiting |
| Vallejo, California, United States, 94589 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| Scripps Cancer Center - San Diego | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: James R. Mason, MD 858-554-8597 | |
| Sutter Health - Western Division Cancer Research Group | Recruiting |
| Greenbrae, California, United States, 94904 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| Peninsula Medical Center | Recruiting |
| Burlingame, California, United States, 94010 | |
| Contact: David H. Irwin, MD 510-204-1591 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| United States, Idaho | |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Recruiting |
| Boise, Idaho, United States, 83712 | |
| Contact: William H. Kreisle, MD 208-381-2711 | |
| United States, Kansas | |
| Tammy Walker Cancer Center at Salina Regional Health Center | Recruiting |
| Salina, Kansas, United States, 67401 | |
| Contact: William F. Cathcart-Rake, MD 785-452-4860 | |
| Wesley Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| United States, Louisiana | |
| Tulane Cancer Center Office of Clinical Research | Recruiting |
| Alexandria, Louisiana, United States, 71315-3198 | |
| Contact: Clinical Trials Office - Tulane Cancer Center 504-988-6121 | |
| United States, Massachusetts | |
| Boston University Cancer Research Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-353-7571 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| Josephine Ford Cancer Center at Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Robert A. Chapman, MD 313-916-1332 | |
| United States, Missouri | |
| Saint Louis University Cancer Center | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Clinical Trials Office - Saint Louis University Cancer Center 314-977-4440 | |
| United States, Montana | |
| Big Sky Oncology | Recruiting |
| Great Falls, Montana, United States, 59405-5309 | |
| Contact: Clinical Trail Office - Big Sky Oncology 406-731-8217 | |
| Billings Clinic - Downtown | Recruiting |
| Billings, Montana, United States, 59107-7000 | |
| Contact: Clinical Trials Office - Billings Clinic - Downtown 800-996-2663 research@billingsclinic.org | |
| Bozeman Deaconess Cancer Center | Recruiting |
| Bozeman, Montana, United States, 59715 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| CCOP - Montana Cancer Consortium | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Community Medical Center | Recruiting |
| Missoula, Montana, United States, 59801 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Glacier Oncology, PLLC | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Great Falls Clinic - Main Facility | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Guardian Oncology and Center for Wellness | Recruiting |
| Missoula, Montana, United States, 59804 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Northern Rockies Radiation Oncology Center | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Kalispell Medical Oncology at KRMC | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Kalispell Regional Medical Center | Recruiting |
| Kalispell, Montana, United States, 59901 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Recruiting | |
| Great Falls, Montana, United States, 59405 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Recruiting |
| Missoula, Montana, United States, 59807 | |
| Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick 406-329-7029 | |
| Montana Cancer Specialists at Montana Cancer Center | Recruiting |
| Missoula, Montana, United States, 59807-7877 | |
| Contact: Clinical Trials Office - Montana Cancer Specialists at Montana 406-238-6962 | |
| Northern Montana Hospital | Recruiting |
| Havre, Montana, United States, 59501 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Sletten Cancer Institute at Benefis Healthcare | Recruiting |
| Great Falls, Montana, United States, 59405 | |
| Contact: Grant W. Harrer, MD, FACP, CCTI 406-731-8100 | |
| St. James Healthcare Cancer Care | Recruiting |
| Butte, Montana, United States, 59701 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| St. Peter's Hospital | Recruiting |
| Helena, Montana, United States, 59601 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| St. Vincent Healthcare Cancer Care Services | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Richard I. Fisher, MD 585-275-0842 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| United States, Oregon | |
| Adventist Medical Center | Recruiting |
| Portland, Oregon, United States, 97216 | |
| Contact: Keith S. Lanier, MD 503-299-6500 | |
| CCOP - Columbia River Oncology Program | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Keith S. Lanier, MD 503-299-6500 | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| Providence St. Vincent Medical Center | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Clinical Trials Office - Providence St. Vincent Medical Center 503-215-6412 | |
| Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Contact: Clinical Trials Office - Legacy Good Samaritan Hospital & Com 503-413-1742 | |
| Legacy Meridian Park Hospital | Recruiting |
| Tualatin, Oregon, United States, 97062 | |
| Contact: Clinical Trials Office - Legacy Meridian Park Hospital 503-413-1742 | |
| Legacy Mount Hood Medical Center | Recruiting |
| Gresham, Oregon, United States, 97030 | |
| Contact: Clinical Trials Office - Legacy Mount Hood Medical Center 503-413-2150 | |
| Northwest Cancer Specialists at Rose Quarter Cancer Center | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Kasra Karamlou 503-228-6509 | |
| Providence Cancer Center at Providence Portland Medical Center | Recruiting |
| Portland, Oregon, United States, 97213-2967 | |
| Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 | |
| Providence Milwaukie Hospital | Recruiting |
| Milwaukie, Oregon, United States, 97222 | |
| Contact: Keith S. Lanier, MD 503-299-6500 | |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce 503-413-8199 | |
| United States, Tennessee | |
| Thompson Cancer Survival Center | Recruiting |
| Knoxville, Tennessee, United States, 37916 | |
| Contact: Clinical Trials Office - Thompson Cancer Survival Center 865-541-1812 | |
| United States, Washington | |
| Cancer Care Northwest - Spokane South | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South 509-228-1083 | |
| Columbia Basin Hematology | Recruiting |
| Kennewick, Washington, United States, 99336 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Group Health Central Hospital | Recruiting |
| Seattle, Washington, United States, 98112 | |
| Contact: Clinical Trials Office - Group Health Central Hospital 206-287-2900 | |
| Olympic Hematology and Oncology | Recruiting |
| Bremerton, Washington, United States, 98310 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Legacy Salmon Creek Medical Center | Recruiting |
| Vancouver, Washington, United States, 98686 | |
| Contact: Kasra Karamlou 360-487-1000 | |
| Minor and James Medical, PLLC | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Harborview Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Polyclinic First Hill | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Southwest Washington Medical Center Cancer Center | Recruiting |
| Vancouver, Washington, United States, 98668 | |
| Contact: Keith S. Lanier, MD 503-299-6500 | |
| St. Joseph Cancer Center | Recruiting |
| Bellingham, Washington, United States, 98225 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Recruiting |
| Seattle, Washington, United States, 98122-4307 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| University Cancer Center at University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195-6043 | |
| Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289 | |
| United States, West Virginia | |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Recruiting |
| Parkersburg, West Virginia, United States, 26102 | |
| Contact: Clinical Trials Office - Community Comprehensive Cancer Center 304-424-2585 | |
| United States, Wyoming | |
| Rocky Mountain Oncology | Recruiting |
| Casper, Wyoming, United States, 82609 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Welch Cancer Center at Sheridan Memorial Hospital | Recruiting |
| Sheridan, Wyoming, United States, 82801 | |
| Contact: Benjamin T. Marchello, MD 406-238-6290 | |
| Investigator: | Vaishali Sanchorawala, MD | Boston Medical Center |
| Investigator: | David C. Seldin, MD, PhD | Boston Medical Center |
More Information
| Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
| Study ID Numbers: | CDR0000315382, SWOG-S0115 |
| Study First Received: | July 8, 2003 |
| Last Updated: | November 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00064337 History of Changes |
| Health Authority: | Unspecified |
|
primary systemic amyloidosis stage II multiple myeloma stage III multiple myeloma |
|
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Angiogenesis Modulating Agents Immunoproliferative Disorders Metabolic Diseases Immune System Diseases |
Antineoplastic Agents, Hormonal Hematologic Diseases Glucocorticoids Multiple Myeloma Neoplasms Leprostatic Agents Melphalan Immunologic Factors Thalidomide Blood Protein Disorders Antineoplastic Agents Paraproteinemias Cyclophosphamide Hemostatic Disorders Anti-Bacterial Agents |