A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)
18 Years
65 Years
Both
Multiple Myeloma
Trial Information
A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Outcome Time Frame:
6 years
Safety Issue:
No
Principal Investigator
Mohamad A. Hussein, MD
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000069421
NCT ID:
NCT00040937
Start Date:
June 2002
Completion Date:
July 2012
Related Keywords:
- Multiple Myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Sutter Cancer Center | Sacramento, California 95816 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| Thompson Cancer Survival Center | Knoxville, Tennessee 37916 |
| Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
| Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids, Michigan 49503-2560 |
| Greenville Hospital System Cancer Center | Greenville, South Carolina 29605 |
| Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
| Mecosta County General Hospital | Big Rapids, Michigan 49307 |
| Metropolitan Hospital | Grand Rapids, Michigan 49506 |
| Lacks Cancer Center at Saint Mary's Mercy Medical Center | Grand Rapids, Michigan 49503 |
| Holland Community Hospital | Holland, Michigan 49423 |
| Hackley Hospital | Muskegon, Michigan 49443 |
| Northern Michigan Hospital | Petoskey, Michigan 49770 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| St. Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
| Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
| Internal Medicine Associates of Bozeman | Bozeman, Montana 59715 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| Big Sky Oncology | Great Falls, Montana 59405 |
| Sletten Regional Cancer Institute | Great Falls, Montana 59405 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Medical Oncology | Kalispell, Montana 59901 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Eastern Montana Cancer Center | Miles City, Montana 59301 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grant Riverside Cancer Services | Columbus, Ohio 43215 |
| Mount Carmel West Hospital | Columbus, Ohio 43222 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Fairfield Medical Center | Lancaster, Ohio 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Mercy Medical Center Oncology Unit | Springfield, Ohio 45504 |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| St. Joseph Hospital Community Cancer Center | Bellingham, Washington 98225 |
| Olympic Hematology and Oncology | Bremerton, Washington 98310 |
| Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Central Washington Hospital | Wenatchee, Washington 98801 |
| Wenatchee Valley Clinic | Wenatchee, Washington 98801 |
| Welch Cancer Center | Sheridan, Wyoming 82801 |
| Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
| Piedmont Hospital | Atlanta, Georgia 30309 |
| WellStar Cobb Hospital | Austell, Georgia 30106 |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
| Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
| Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
| Salina Regional Health Center | Salina, Kansas 67401 |
| Stormont-Vail Cancer Center | Topeka, Kansas 66604 |
| St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
| Louisiana State University Health Sciences Center - Monroe | Monroe, Louisiana 71210 |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
| Bay Regional Medical Center | Bay City, Michigan 48708 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
| Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence St. Vincent Medical Center | Portland, Oregon 97225 |
| Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
| Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
| UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| St. Francis Hospital | Federal Way, Washington 98003 |
| St. Clare Hospital | Lakewood, Washington 98499-0998 |
| Capital Medical Center | Olympia, Washington 98502 |
| Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
| Good Samaritan Cancer Center | Puyallup, Washington 98371 |
| St. Joseph Medical Center at Franciscan Health System | Tacoma, Washington 98405-3004 |
| Allenmore Hospital | Tacoma, Washington 98411-0414 |
| St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
| Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center | Portland, Oregon 97210 |
| Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
| St. Francis Medical Center | Honolulu, Hawaii 96817 |
| Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
| Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Judy L. Schmidt, MD, FACP, P. C. | Missoula, Montana 59804 |
| MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
| Sutter Roseville Medical Center | Roseville, California 95661 |
| Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
| Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
| Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
| OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
| OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
| United States Air Force Medical Center Wright-Patterson | Wright-Patterson Afb, Ohio 45433-5529 |
| Regional Cancer Center at Providence Hospital | Centralia, Washington 98531 |
