S0417 A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma
OBJECTIVES:
- Determine the confirmed overall response rate (complete remission, remission, and
partial remission) in patients with relapsed or refractory multiple myeloma treated
with bortezomib, thalidomide, and dexamethasone.
- Determine overall and progression-free survival of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
- Correlate, preliminarily, treatment with bortezomib with the activation of osteoblasts
in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral
thalidomide once daily on days 1-21, and oral dexamethasone once daily on days 1, 2, 4,
5, 8, 9, 11, and 12. Treatment repeats every 21 days until achievement of confirmed
complete remission (CR), remission (R), or partial remission (PR) OR for up to 8
courses in the absence of disease progression or unacceptable toxicity.
Patients achieving confirmed CR, R, or PR who reach a plateau prior to receiving the maximum
8 courses of induction therapy OR who achieve confirmed CR, R, or PR after receiving the
maximum 8 courses of induction therapy proceed to maintenance therapy. Patients achieving
stable disease after receiving the maximum 8 courses of induction therapy either proceed to
maintenance therapy or receive further treatment with bortezomib, thalidomide, and
dexamethasone off-study.
- Maintenance therapy: Patients receive oral dexamethasone on days 1-4. Courses repeat
every 28 days for up to 3 years in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed within 30 days and then every 6
months for up to 5 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).
Responses are defined as follows: Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%. Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein < 0.2gm/day. Bone marrow plasma cells must be ≤ 5%. Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level.
1 year
No
Gordan Srkalovic, MD, PhD
Principal Investigator
Sparrow Regional Cancer Center
United States: Federal Government
CDR0000435925
NCT00124579
August 2005
June 2010
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Foote Hospital | Jackson, Michigan 49201 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Wesley Medical Center | Wichita, Kansas 67214 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Munson Medical Center | Traverse City, Michigan 49684 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
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 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
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 |
Tod Children's Hospital | Youngstown, Ohio 44501 |
Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
Hematology Oncology Consultants - Naperville | Naperville, Illinois 60540 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
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 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
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 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
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 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Ben Taub General Hospital | Houston, Texas 77030 |
Methodist Hospital | Houston, Texas 77030 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Great Falls, Montana 59405 | |
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital | Houston, Texas 77030 |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |
Center for Cancer Medicine and Blood Disorders, PA | El Paso, Texas 79902 |