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S0417 A Phase II Study of Bortezomib (Velcade™, PS-341), Thalidomide, and Dexamethasone in Patients With Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of multiple myeloma (MM)

- Active disease

- Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included
autologous or allogeneic stem cell transplantation

- Relapse is defined as the occurrence of any of the following during or after
prior treatment:

- Myeloma protein level increase by > 100% from the lowest previously
recorded level

- Myeloma protein level increase above the defined response criteria for
partial remission

- Reappearance of any myeloma peak that had disappeared during the prior
treatment

- Increase in the size and number of lytic bone lesions and/or focal lesions
by x-ray, MRI, positron emission tomography, and/or CT scan

- Refractory disease is defined as no response (i.e., not achieving complete
remission, remission, or partial remission) to prior therapy

- Measurable disease

- No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of
M-protein, and skin changes) syndrome

- Must be registered on protocol SWOG-S0334

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-2 (unless due to bone pain)

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,000/mm^3

- Platelet count > 50,000/mm^3

Hepatic

- AST or ALT ≤ 3 times upper limit of normal (ULN)

- Bilirubin ≤ 3 times ULN

Renal

- Creatinine clearance > 30 mL/min

Cardiovascular

- No New York Heart Association class III or IV congestive heart failure

- No myocardial infarction within the past 6 months

- No poorly controlled hypertension

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile female patients must use effective double method contraception for ≥ 4 weeks
before, during, and for ≥ 4 weeks after completion of study treatment (during and for
4 weeks after completion of study treatment for male patients)

- No blood, ova, or sperm donation during study treatment

- No active infection requiring antibiotics

- No neurotoxicity ≥ grade 2

- No diabetes mellitus

- No other serious medical or psychiatric illness that would preclude study treatment

- No other malignancy within the past 3 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered

Endocrine therapy

- Not specified

Radiotherapy

- At least 14 days since prior radiotherapy and recovered

Surgery

- Not specified

Other

- No prior bortezomib alone or combined with thalidomide

- Concurrent participation on protocol SWOG-S0309 allowed

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Gordan Srkalovic, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sparrow Regional Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000435925

NCT ID:

NCT00124579

Start Date:

August 2005

Completion Date:

June 2010

Related Keywords:

  • Multiple Myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Wesley Medical CenterWichita, Kansas  67214
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Latter Day Saints HospitalSalt Lake City, Utah  84143
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
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
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
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
Tod Children's HospitalYoungstown, Ohio  44501
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Hematology Oncology Consultants - NapervilleNaperville, Illinois  60540
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Mecosta County Medical CenterBig Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Ben Taub General HospitalHouston, Texas  77030
Methodist HospitalHouston, Texas  77030
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Pardee Memorial HospitalHendersonville, North Carolina  28791
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Great Falls, Montana  59405
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
AnMed Cancer CenterAnderson, South Carolina  29621
St. Luke's Texas Cancer Institute at St. Luke's Episcopal HospitalHouston, Texas  77030
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115
Center for Cancer Medicine and Blood Disorders, PAEl Paso, Texas  79902