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S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
sargramostim
cyclophosphamide
dexamethasone
melphalan
prednisone
thalidomide
peripheral blood stem cell transplantation
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • University of California Davis Cancer Center
  • Sutter Roseville Medical Center
  • Sutter Cancer Center
  • Piedmont Hospital
  • CCOP - Atlanta Regional
  • Northside Hospital Cancer Center
  • Saint Joseph's Hospital of Atlanta
  • WellStar Cobb Hospital
  • Charles B. Eberhart Cancer Center at DeKalb Medical Center
  • Gwinnett Medical Center
  • Kennestone Cancer Center at Wellstar Kennestone Hospital
  • Southern Regional Medical Center
  • Kapiolani Medical Center at Pali Momi
  • Cancer Research Center of Hawaii
  • OnCare Hawaii, Incorporated - Lusitana
  • Queen's Cancer Institute at Queen's Medical Center
  • Straub Clinic and Hospital, Incorporated
  • OnCare Hawaii, Incorporated - Kuakini
  • St. Francis Medical Center
  • Kapiolani Medical Center for Women and Children
  • St. Luke's Mountain States Tumor Institute - Boise
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • St. Francis Hospital and Health Centers
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Salina Regional Health Center
  • Stormont-Vail Cancer Center
  • St. Francis Comprehensive Cancer Center
  • Wesley Medical Center
  • Louisiana State University Health Sciences Center - Monroe
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • University of Michigan Comprehensive Cancer Center
  • Battle Creek Health System Cancer Care Center
  • Bay Regional Medical Center
  • Mecosta County General Hospital
  • CCOP - Grand Rapids
  • Lacks Cancer Center at Saint Mary's Mercy Medical Center
  • Spectrum Health Cancer Care - Butterworth Campus
  • Metropolitan Hospital
  • Holland Community Hospital
  • Hackley Hospital
  • Northern Michigan Hospital
  • Munson Medical Center
  • University of Mississippi Medical Center
  • CCOP - Kansas City
  • CCOP - Montana Cancer Consortium
  • Deaconess Billings Clinic - Downtown
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Northern Rockies Radiation Oncology Center
  • St. Vincent Healthcare
  • Deaconess Billings Clinic Cancer Center
  • Bozeman Deaconess Hospital
  • Internal Medicine Associates of Bozeman
  • St. James Community Hospital
  • Big Sky Oncology
  • Great Falls Clinic
  • Sletten Regional Cancer Institute
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Eastern Montana Cancer Center
  • Community Medical Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Montana Cancer Specialists at Montana Cancer Center
  • Judy L. Schmidt, MD, FACP, P. C.
  • Interlakes Oncology/Hematology PC
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Rutherford Hospital
  • Comprehensive Cancer Center at Wake Forest University
  • McDowell Cancer Center at Akron General Medical Center
  • Adena Regional Medical Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Riverside Cancer Services
  • Mount Carmel West Hospital
  • Doctors Hospital at Ohio Health
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • Grady Memorial Hospital
  • Charles F. Kettering Memorial Hospital
  • Fairfield Medical Center
  • MedCentral - Mansfield Hospital
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Middletown Regional Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Mercy Medical Center Oncology Unit
  • Community Hospital of Springfield and Clark County
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  • United States Air Force Medical Center Wright-Patterson
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Genesis - Good Samaritan Hospital
  • Legacy Mount Hood Medical Center
  • Providence Milwaukie Hospital
  • Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
  • Providence Cancer Center at Providence Portland Medical Center
  • CCOP - Columbia River Oncology Program
  • Providence St. Vincent Medical Center
  • Institute of Oncology at Vilnius University
  • Cancer Institute at Oregon Health and Science University
  • Legacy Meridian Park Hospital
  • Rose Ramer Cancer Clinic at Anderson Area Medical Center
  • Bon Secours St. Francis Health System
  • Greenville Hospital System Cancer Center
  • CCOP - Greenville
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • CCOP - Upstate Carolina
  • Thompson Cancer Survival Center
  • Brooke Army Medical Center
  • Wilford Hall Medical Center
  • UMC Southwest Cancer and Research Center
  • Auburn Regional Center for Cancer Care
  • St. Joseph Hospital Community Cancer Center
  • Olympic Hematology and Oncology
  • Regional Cancer Center at Providence Hospital
  • St. Francis Hospital
  • Skagit Valley Hospital Cancer Care Center
  • Providence St. Peter Hospital Regional Cancer Center
  • Capital Medical Center
  • Good Samaritan Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Group Health Central Hospital
  • Harborview Medical Center
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • University Cancer Center at University of Washington Medical Center
  • North Puget Oncology at United General Hospital
  • Cancer Care Northwest - Spokane South
  • Allenmore Hospital
  • CCOP - Northwest
  • St. Joseph Medical Center at Franciscan Health System
  • St. Clare Hospital
  • Southwest Washington Medical Center Cancer Center
  • Central Washington Hospital
  • Wenatchee Valley Clinic
  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.

Full Information

First Posted
July 8, 2002
Last Updated
October 26, 2016
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00040937
Brief Title
S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma
Official Title
A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
G-CSF
Intervention Description
PBSC collection: 10 mcg/kg SQ days 1-10
Intervention Type
Biological
Intervention Name(s)
sargramostim
Other Intervention Name(s)
GM-CSF
Intervention Description
PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis 1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
cytoxan
Intervention Description
PBSC collection: 1 mg/m2 IV over 45-60 mins day 0
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
decadron
Intervention Description
40 mg/d PO days 1-4, 9-12, 17-20
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Description
st trans: 140 mg/m2 IV over 20 mins day -1 nd trans: 200mg/m2 IV over 20 mins day -1
Intervention Type
Drug
Intervention Name(s)
prednisone
Other Intervention Name(s)
steroid
Intervention Description
maint: 50 mg/d PO every other day until progression
Intervention Type
Drug
Intervention Name(s)
thalidomide
Other Intervention Name(s)
thalomid
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Other Intervention Name(s)
stem cell transplant
Intervention Description
2-4 x 10^6/kg IV day 0
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
4-7 years
Secondary Outcome Measure Information:
Title
Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.
Description
To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.
Time Frame
Induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad A. Hussein, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California Davis Cancer Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital Cancer Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Saint Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
WellStar Cobb Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Charles B. Eberhart Cancer Center at DeKalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Kennestone Cancer Center at Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Southern Regional Medical Center
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Kapiolani Medical Center at Pali Momi
City
Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolula
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Lusitana
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Institute at Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital, Incorporated
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
St. Francis Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
St. Francis Hospital and Health Centers
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Stormont-Vail Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
St. Francis Comprehensive Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Monroe
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71210
Country
United States
Facility Name
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Battle Creek Health System Cancer Care Center
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Bay Regional Medical Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Mecosta County General Hospital
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Mercy Medical Center
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Cancer Care - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Metropolitan Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Holland Community Hospital
City
Holland
State/Province
Michigan
ZIP/Postal Code
49423
Country
United States
Facility Name
Hackley Hospital
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49443
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Deaconess Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Deaconess Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Internal Medicine Associates of Bozeman
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Community Hospital
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Regional Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Eastern Montana Cancer Center
City
Miles City
State/Province
Montana
ZIP/Postal Code
59301
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Judy L. Schmidt, MD, FACP, P. C.
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Interlakes Oncology/Hematology PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
54601
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Riverside Cancer Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
MedCentral - Mansfield Hospital
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44903
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Middletown Regional Hospital
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Mercy Medical Center Oncology Unit
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
United States Air Force Medical Center Wright-Patterson
City
Wright-Patterson Afb
State/Province
Ohio
ZIP/Postal Code
45433-5529
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Legacy Mount Hood Medical Center
City
Glesham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Providence Milwaukie Hospital
City
Milwaukie
State/Province
Oregon
ZIP/Postal Code
97222
Country
United States
Facility Name
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Institute of Oncology at Vilnius University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Legacy Meridian Park Hospital
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Rose Ramer Cancer Clinic at Anderson Area Medical Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Bon Secours St. Francis Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Greenville Hospital System Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29304
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland AFB
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
UMC Southwest Cancer and Research Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Facility Name
Auburn Regional Center for Cancer Care
City
Auburn
State/Province
Washington
ZIP/Postal Code
98002
Country
United States
Facility Name
St. Joseph Hospital Community Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Regional Cancer Center at Providence Hospital
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
St. Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Skagit Valley Hospital Cancer Care Center
City
Mt. Vernon
State/Province
Washington
ZIP/Postal Code
98273
Country
United States
Facility Name
Providence St. Peter Hospital Regional Cancer Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
95806
Country
United States
Facility Name
Capital Medical Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98507
Country
United States
Facility Name
Good Samaritan Cancer Center
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98114
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
North Puget Oncology at United General Hospital
City
Sedro-Wooley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Allenmore Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St. Joseph Medical Center at Franciscan Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St. Clare Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Southwest Washington Medical Center Cancer Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98668
Country
United States
Facility Name
Central Washington Hospital
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Wenatchee Valley Clinic
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
City
Parkersburg
State/Province
West Virginia
ZIP/Postal Code
26101
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19546405
Citation
Hussein MA, Bolejack V, Zonder JA, Durie BG, Jakubowiak AJ, Crowley JJ, Barlogie B. Phase II study of thalidomide plus dexamethasone induction followed by tandem melphalan-based autotransplantation and thalidomide-plus-prednisone maintenance for untreated multiple myeloma: a southwest oncology group trial (S0204). J Clin Oncol. 2009 Jul 20;27(21):3510-7. doi: 10.1200/JCO.2008.19.9240. Epub 2009 Jun 22.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

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