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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
Not Enrolling
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


- 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

- 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

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


- 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

- 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



- 18 and over

Performance status

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

Life expectancy

- Not specified


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

- Platelet count > 50,000/mm^3


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

- Bilirubin ≤ 3 times ULN


- Creatinine clearance > 30 mL/min


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

- No myocardial infarction within the past 6 months

- No poorly controlled hypertension


- 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


Biologic therapy

- See Disease Characteristics


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

Endocrine therapy

- Not specified


- At least 14 days since prior radiotherapy and recovered


- Not specified


- No prior bortezomib alone or combined with thalidomide

- Concurrent participation on protocol SWOG-S0309 allowed

Type of Study:


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:


Principal Investigator

Gordan Srkalovic, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sparrow Regional Cancer Center


United States: Federal Government

Study ID:




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



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