Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00040937

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 and Plasma Cell Neoplasm	Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: dexamethasone Drug: melphalan Drug: prednisone Drug: thalidomide Procedure: peripheral blood stem cell transplantation	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Safety [ Designated as safety issue: Yes ]
Correlation of chromosome 13 abnormalities with therapeutic response [ Designated as safety issue: No ]
Correlation of chromosome aberrations with event-free survival and overall survival [ Designated as safety issue: No ]
Immune reconstitution and recovery [ Designated as safety issue: No ]

Study Start Date:

June 2002

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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Locations

United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Sutter Cancer Center
Sacramento, California, United States, 95816
Sutter Roseville Medical Center
Roseville, California, United States, 95661
University of California Davis Cancer Center
Davis, California, United States, 95616
United States, Georgia
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
United States, Hawaii
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Cancer Research Center of Hawaii
Honolula, Hawaii, United States, 96813
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
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, United States, 71210
United States, Michigan
Hackley Hospital
Muskegon, Michigan, United States, 49443
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Holland Community Hospital
Holland, Michigan, United States, 49423
Lacks Cancer Center at Saint Mary's Mercy Medical Center
Grand Rapids, Michigan, United States, 49503
Mecosta County General Hospital
Big Rapids, Michigan, United States, 49307
Metropolitan Hospital
Grand Rapids, Michigan, United States, 49506
Munson Medical Center
Traverse City, Michigan, United States, 49684
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States, 49503
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
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
Big Sky Oncology
Great Falls, Montana, United States, 59405
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59101
Great Falls Clinic
Great Falls, Montana, United States, 59405
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States, 59715
Judy L. Schmidt, MD, FACP, P. C.
Missoula, Montana, United States, 59804
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59802
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59802
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Sletten Regional Cancer Institute
Great Falls, Montana, United States, 59405
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
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
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, Ohio
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Adena Regional Medical Center
Chillicothe, Ohio, United States, 54601
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grandview Hospital
Dayton, Ohio, United States, 45405
Grant Riverside Cancer Services
Columbus, Ohio, United States, 43215
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States, 44903
Mercy Medical Center Oncology Unit
Springfield, Ohio, United States, 45504
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States, 43081
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
United States Air Force Medical Center Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
United States, Oregon
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
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
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
Legacy Mount Hood Medical Center
Glesham, Oregon, United States, 97030
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29304
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States, 29605
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
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
UMC Southwest Cancer and Research Center
Lubbock, Texas, United States, 79415
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
United States, Washington
Regional Cancer Center at Providence Hospital
Centralia, Washington, United States, 98531
Allenmore Hospital
Tacoma, Washington, United States, 98405
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
CCOP - Northwest
Tacoma, Washington, United States, 98405
Central Washington Hospital
Wenatchee, Washington, United States, 98801
Capital Medical Center
Olympia, Washington, United States, 98507
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Group Health Central Hospital
Seattle, Washington, United States, 98104
Harborview Medical Center
Seattle, Washington, United States, 98104
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
St. Clare Hospital
Tacoma, Washington, United States, 98499
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 95806
St. Francis Hospital
Federal Way, Washington, United States, 98003
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, United States, 98405
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
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

National Cancer Institute (NCI)

Investigators

Study Chair:

Mohamad A. Hussein, MD

The Cleveland Clinic

Study ID Numbers:	CDR0000069421, SWOG-S0204
Study First Received:	July 8, 2002
Last Updated:	July 10, 2009
ClinicalTrials.gov Identifier:	NCT00040937 History of Changes
Health Authority:	United States: Federal Government