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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 CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
CCOP - NorthwestTacoma, Washington  98405-0986
Sutter Cancer CenterSacramento, California  95816
University of California Davis Cancer CenterSacramento, California  95817
Wesley Medical CenterWichita, Kansas  67214
Great Falls ClinicGreat Falls, Montana  59405
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Mecosta County General HospitalBig Rapids, Michigan  49307
Metropolitan HospitalGrand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical CenterGrand Rapids, Michigan  49503
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Northern Michigan HospitalPetoskey, Michigan  49770
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Internal Medicine Associates of BozemanBozeman, Montana  59715
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mercy Medical Center Oncology UnitSpringfield, Ohio  45504
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Central Washington HospitalWenatchee, Washington  98801
Wenatchee Valley ClinicWenatchee, Washington  98801
Welch Cancer CenterSheridan, Wyoming  82801
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Salina Regional Health CenterSalina, Kansas  67401
Stormont-Vail Cancer CenterTopeka, Kansas  66604
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Louisiana State University Health Sciences Center - MonroeMonroe, Louisiana  71210
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Bay Regional Medical CenterBay City, Michigan  48708
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Capital Medical CenterOlympia, Washington  98502
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical CenterPortland, Oregon  97210
Institute of Oncology at Vilnius UniversityPortland, Oregon  97227
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
St. Francis Medical CenterHonolulu, Hawaii  96817
Auburn Regional Center for Cancer CareAuburn, Washington  98002
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Judy L. Schmidt, MD, FACP, P. C.Missoula, Montana  59804
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Sutter Roseville Medical CenterRoseville, California  95661
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
United States Air Force Medical Center Wright-PattersonWright-Patterson Afb, Ohio  45433-5529
Regional Cancer Center at Providence HospitalCentralia, Washington  98531