S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
This study is ongoing, but not recruiting participants.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00040937
First received: July 8, 2002
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma.
PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: dexamethasone Drug: melphalan Drug: prednisone Drug: thalidomide Procedure: peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study) |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Thalidomide
Prednisone
Melphalan
Dexamethasone acetate
Dexamethasone sodium phosphate
Melphalan hydrochloride
Filgrastim
Sargramostim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Efficacy [ Time Frame: 6 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 99 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | July 2012 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: treatment arm
thalidomide/dexamethasone followed by tandem melphalan transplant and prednisone/thalidomide maintenance
|
Biological: filgrastim
PBSC collection: 10 mcg/kg SQ days 1-10
Other Name: G-CSF
Biological: sargramostim
PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis 1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery Other Name: GM-CSF
Drug: cyclophosphamide
PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
Other Name: cytoxan
Drug: dexamethasone
40 mg/d PO days 1-4, 9-12, 17-20
Other Name: decadron
Drug: melphalan
maint: 50 mg/d PO every other day until progression
Other Name: steroid
Drug: thalidomide
ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression
Other Name: thalomid
Procedure: peripheral blood stem cell transplantation
2-4 x 10^6/kg IV day 0
Other Name: stem cell transplant
|
Detailed Description:
OBJECTIVES:
- Determine the efficacy and toxicity of thalidomide and dexamethasone as a pre-transplantation induction regimen in patients with multiple myeloma.
- Determine, preliminarily, the safety and efficacy of prednisone and thalidomide maintenance therapy in these patients.
- Correlate chromosome 13 abnormalities with therapeutic response in patients treated with this regimen.
- Correlate specific subsets of chromosome aberrations with event-free and overall survival of patients treated with this regimen.
- Evaluate immune reconstitution and recovery after first and second transplantation in these patients.
OUTLINE: This is a multicenter study.
- Induction chemotherapy: Patients receive oral thalidomide once daily on days 1-35 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Treatment repeats every 35 days for 3 courses in the absence of disease progression or unacceptable toxicity.
- Stem cell mobilization and collection: Beginning 5-7 days, but no more than 3 weeks, after completion of induction chemotherapy, patients receive cyclophosphamide IV over 45-60 minutes on day 0, filgrastim (G-CSF) subcutaneously (SC) on days 1-10, and sargramostim (GM-CSF) SC beginning on day 1 and continuing until completion of peripheral blood stem cell (PBSC) collection. Patients begin PBSC collection on day 11 or as soon as blood counts recover.
- First transplantation: Within 3-6 weeks after cyclophosphamide administration, patients receive melphalan IV over 20 minutes on day -1. Patients undergo PBSC infusion on day 0. Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood counts recover.
- Second transplantation: Between 2-4 months after first transplantation, patients undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as above.
- Maintenance therapy: Beginning 70-90 days post-transplantation, patients receive oral prednisone every other day and oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 months for 10 years.
PROJECTED ACCRUAL: Approximately 99 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Newly diagnosed multiple myeloma requiring treatment
Smoldering myeloma with evidence of progressive disease requiring chemotherapy
- More than 25% increase in M component levels and/or Bence-Jones excretion or symptom development
- Non-secretory patients with at least 30% bone marrow plasmacytosis
- No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or more than 3 lytic lesions
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Performance status
- Zubrod 0-2 OR
- Zubrod 3-4 based solely on bone pain
Life expectancy
- Not specified
Hematopoietic
- No untreated, unresolved symptomatic hyperviscosity
Hepatic
- Hepatitis B negative
Renal
- Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after hydration and/or correction of hypercalcemia)
Cardiovascular
- No history of chronic cerebrovascular accident
- No myocardial infarction within the past 6 months
- No unstable angina
- No congestive heart failure that is difficult to control
- No uncontrollable hypertension
- No cardiac arrhythmia that is difficult to control
Pulmonary
- No history of chronic obstructive or chronic restrictive pulmonary disease
- No untreated, unresolved pneumonia
- Pulmonary function tests (PFTs) at least 50% of predicted
- DLCO at least 50% of predicted
- Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to bone pain or fracture
Other
- HIV negative
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No untreated, unresolved pathologic fractures
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use at least 2 highly effective methods of contraception for 4 weeks before, during, and for at least 4 weeks after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No more than 8 weeks of prior thalidomide therapy
Chemotherapy
- No prior chemotherapy for this disease
Endocrine therapy
- Prior steroid therapy allowed provided treatment duration was no more than 2 weeks
Radiotherapy
- No prior radiotherapy to more than 50% of the pelvis
Surgery
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040937
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| United States, Arkansas | |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| University of California Davis Cancer Center | |
| Davis, California, United States, 95616 | |
| Sutter Roseville Medical Center | |
| Roseville, California, United States, 95661 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| United States, Georgia | |
| Saint Joseph's Hospital of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| Northside Hospital Cancer Center | |
| Atlanta, Georgia, United States, 30342 | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342 | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| WellStar Cobb Hospital | |
| Austell, Georgia, United States, 30106 | |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| Gwinnett Medical Center | |
| Lawrenceville, Georgia, United States, 30045 | |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | |
| Marietta, Georgia, United States, 30060 | |
| Southern Regional Medical Center | |
| Riverdale, Georgia, United States, 30274 | |
| United States, Hawaii | |
| Kapiolani Medical Center at Pali Momi | |
| Aiea, Hawaii, United States, 96701 | |
| Cancer Research Center of Hawaii | |
| Honolula, Hawaii, United States, 96813 | |
| Kapiolani Medical Center for Women and Children | |
| Honolulu, Hawaii, United States, 96826 | |
| OnCare Hawaii, Incorporated - Kuakini | |
| Honolulu, Hawaii, United States, 96817 | |
| OnCare Hawaii, Incorporated - Lusitana | |
| Honolulu, Hawaii, United States, 96813 | |
| Queen's Cancer Institute at Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| St. Francis Medical Center | |
| Honolulu, Hawaii, United States, 96817 | |
| Straub Clinic and Hospital, Incorporated | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| St. Luke's Mountain States Tumor Institute - Boise | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| St. Francis Hospital and Health Centers | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Kansas | |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Salina Regional Health Center | |
| Salina, Kansas, United States, 67401 | |
| St. Francis Comprehensive Cancer Center | |
| Topeka, Kansas, United States, 66606 | |
| Stormont-Vail Cancer Center | |
| Topeka, Kansas, United States, 66604 | |
| Wesley Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Louisiana State University Health Sciences Center - Monroe | |
| Monroe, Louisiana, United States, 71210 | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| Battle Creek Health System Cancer Care Center | |
| Battle Creek, Michigan, United States, 49017 | |
| Bay Regional Medical Center | |
| Bay City, Michigan, United States, 48708 | |
| Mecosta County General Hospital | |
| Big Rapids, Michigan, United States, 49307 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| Metropolitan Hospital | |
| Grand Rapids, Michigan, United States, 49506 | |
| Spectrum Health Cancer Care - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| Holland Community Hospital | |
| Holland, Michigan, United States, 49423 | |
| Hackley Hospital | |
| Muskegon, Michigan, United States, 49443 | |
| Northern Michigan Hospital | |
| Petoskey, Michigan, United States, 49770 | |
| Munson Medical Center | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| United States, Montana | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107 | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| Internal Medicine Associates of Bozeman | |
| Bozeman, Montana, United States, 59715 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Sletten Regional Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Medical Oncology | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Eastern Montana Cancer Center | |
| Miles City, Montana, United States, 59301 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59802 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59802 | |
| Judy L. Schmidt, MD, FACP, P. C. | |
| Missoula, Montana, United States, 59804 | |
| United States, New York | |
| Interlakes Oncology/Hematology PC | |
| Rochester, New York, United States, 14623 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| McDowell Cancer Center at Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 54601 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214 | |
| Mount Carmel West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| MedCentral - Mansfield Hospital | |
| Mansfield, Ohio, United States, 44903 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Mercy Medical Center Oncology Unit | |
| Springfield, Ohio, United States, 45504 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373 | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| United States Air Force Medical Center Wright-Patterson | |
| Wright-Patterson Afb, Ohio, United States, 45433-5529 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oregon | |
| Legacy Mount Hood Medical Center | |
| Glesham, Oregon, United States, 97030 | |
| Providence Milwaukie Hospital | |
| Milwaukie, Oregon, United States, 97222 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | |
| Portland, Oregon, United States, 97210 | |
| Institute of Oncology at Vilnius University | |
| Portland, Oregon, United States, 97227 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| Legacy Meridian Park Hospital | |
| Tualatin, Oregon, United States, 97062 | |
| United States, South Carolina | |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| Bon Secours St. Francis Health System | |
| Greenville, South Carolina, United States, 29601 | |
| Greenville Hospital System Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29304 | |
| United States, Tennessee | |
| Thompson Cancer Survival Center | |
| Knoxville, Tennessee, United States, 37916 | |
| United States, Texas | |
| Brooke Army Medical Center | |
| Fort Sam Houston, Texas, United States, 78234 | |
| Wilford Hall Medical Center | |
| Lackland AFB, Texas, United States, 78236 | |
| UMC Southwest Cancer and Research Center | |
| Lubbock, Texas, United States, 79415 | |
| United States, Washington | |
| Auburn Regional Center for Cancer Care | |
| Auburn, Washington, United States, 98002 | |
| St. Joseph Hospital Community Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Regional Cancer Center at Providence Hospital | |
| Centralia, Washington, United States, 98531 | |
| St. Francis Hospital | |
| Federal Way, Washington, United States, 98003 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| Capital Medical Center | |
| Olympia, Washington, United States, 98507 | |
| Providence St. Peter Hospital Regional Cancer Center | |
| Olympia, Washington, United States, 95806 | |
| Good Samaritan Cancer Center | |
| Puyallup, Washington, United States, 98372 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98104 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98114 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| North Puget Oncology at United General Hospital | |
| Sedro-Wooley, Washington, United States, 98284 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| St. Clare Hospital | |
| Tacoma, Washington, United States, 98499 | |
| Allenmore Hospital | |
| Tacoma, Washington, United States, 98405 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405 | |
| St. Joseph Medical Center at Franciscan Health System | |
| Tacoma, Washington, United States, 98405 | |
| Southwest Washington Medical Center Cancer Center | |
| Vancouver, Washington, United States, 98668 | |
| Central Washington Hospital | |
| Wenatchee, Washington, United States, 98801 | |
| Wenatchee Valley Clinic | |
| Wenatchee, Washington, United States, 98801 | |
| United States, West Virginia | |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | |
| Parkersburg, West Virginia, United States, 26101 | |
| United States, Wyoming | |
| Welch Cancer Center | |
| Sheridan, Wyoming, United States, 82801 | |
Sponsors and Collaborators
Southwest Oncology Group
Investigators
| Study Chair: | Mohamad A. Hussein, MD | The Cleveland Clinic |
More Information
Additional Information:
Publications:
Hussein MA, Jakubowiak AJ, Bolejack V, et al.: S0204: melphalan (MEL)-based tandem autotransplants (TAT) for multiple myeloma (MM) with thalidomide/dexamethasone (TD) induction and thalidomide/prednisone (TP) maintenance: a phase II trial of the Southwest Oncology Group. [Abstract] Blood 108 (11): A-3088, 2006.
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00040937 History of Changes |
| Other Study ID Numbers: | CDR0000069421, S0204, U10CA032102 |
| Study First Received: | July 8, 2002 |
| Last Updated: | June 13, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Cyclophosphamide |
Melphalan Thalidomide Dexamethasone Prednisone Lenograstim Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on June 17, 2013