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A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Multiple Myeloma

Thank you

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